ibuprofen and Fever
ibuprofen has been researched along with Fever in 285 studies
Midol: combination of cinnamedrine, phenacetin, aspirin & caffeine
Fever: An abnormal elevation of body temperature, usually as a result of a pathologic process.
Research Excerpts
| Excerpt | Relevance | Reference |
|---|---|---|
| "This study aims to evaluate the efficacy and safety of multiple or single-dosage intravenous ibuprofen (IVIB) in managing postoperative pain and fever in adults who are unable to take oral medications." | 9.41 | Intravenous ibuprofen in postoperative pain and fever management in adults: A systematic review and meta-analysis of randomized controlled trials. ( Chen, L; He, L; Tian, S; Wang, E; Zhai, S; Zhou, P, 2023) |
| "Our primary objective was to assess the effectiveness of paracetamol (acetaminophen) or NSAIDs, alone or combined, compared with placebo or no treatment in relieving pain in children with AOM." | 9.41 | Paracetamol (acetaminophen) or non-steroidal anti-inflammatory drugs, alone or combined, for pain relief in acute otitis media in children. ( Damoiseaux, RA; de Sévaux, JLH; Hay, AD; Little, P; Lutje, V; Schilder, AG; van de Pol, AC; Venekamp, RP, 2023) |
| "In adult age group patients admitted to the emergency department with high fever, the IV forms of 1000 mg paracetamol and 400 mg ibuprofen effectively and equally reduce complaints, such as fever and accompanying pain." | 9.41 | Comparison of intravenous ibuprofen and paracetamol in the treatment of fever: A randomized double-blind study. ( Can, Ö; Kıyan, GS; Yalçınlı, S, 2021) |
| "the overall result showed that ibuprofen had a better fever reducing effect compared to paracetamol." | 9.34 | Ibuprofen versus paracetamol for treating fever in preschool children in Nigeria: a randomized clinical trial of effectiveness and safety. ( Akande, PA; Alaje, EO; Meremikwu, MM; Odey, FA; Udoh, EE, 2020) |
| "No evidence can be found in the medical literature about the efficacy of alternating acetaminophen and ibuprofen treatment in children with refractory fever." | 9.24 | Alternating Acetaminophen and Ibuprofen versus Monotherapies in Improvements of Distress and Reducing Refractory Fever in Febrile Children: A Randomized Controlled Trial. ( Guo, Q; Luo, Q; Luo, S; Ran, M; Shu, M; Wan, C; Xie, X; Zhang, C; Zhu, Y, 2017) |
| "001); in a greater reduction in change from baseline temperature compared to treatment with acetaminophen, and it reduced fever throughout a 24 h dosing period." | 9.24 | A multicenter, randomized, open-label, active-comparator trial to determine the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for treatment of fever in hospitalized pediatric patients. ( Chumpitazi, CE; Hahn, BJ; Kaelin, BA; Khalil, SN; Macias, CG; Rock, AD, 2017) |
| "To evaluate ibuprofen and acetaminophen in the treatment of infectious fever in children." | 9.22 | Comparison between Ibuprofen and Acetaminophen in the Treatment of Infectious Fever in Children: A Meta-Analysis. ( Guo, H; Liu, Y; Yin, F, 2022) |
| "Studies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking." | 9.22 | Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma. ( Bacharier, LB; Baxi, SN; Beigelman, A; Benson, M; Blake, K; Boehmer, SJ; Cabana, MD; Chmiel, JF; Covar, R; Daines, CL; Daines, MO; Fitzpatrick, AM; Gaffin, JM; Gentile, DA; Gower, WA; Holguin, F; Israel, E; Jackson, DJ; Kumar, HV; Lang, JE; Lazarus, SC; Lemanske, RF; Lima, JJ; Ly, N; Marbin, J; Martinez, FD; Mauger, DT; Morgan, WJ; Moy, JN; Myers, RE; Olin, JT; Paul, IM; Peters, SP; Phipatanakul, W; Pongracic, JA; Raissy, HH; Robison, RG; Ross, K; Sheehan, WJ; Sorkness, CA; Szefler, SJ; Thyne, SM; Wechsler, ME, 2016) |
| "To establish the relative clinical effectiveness and cost-effectiveness of paracetamol plus ibuprofen compared with paracetamol and ibuprofen separately for time without fever, and the relief of fever-associated discomfort in young children who can be managed at home." | 9.14 | Paracetamol and ibuprofen for the treatment of fever in children: the PITCH randomised controlled trial. ( Costelloe, C; Fletcher, M; Hay, AD; Hollinghurst, S; Montgomery, AA; Peters, TJ; Redmond, NM, 2009) |
| "Hospitalized patients are often unable to ingest or tolerate oral antipyretics and recently an aqueous formulation of intravenous (IV) ibuprofen was approved by the US-FDA for the reduction of fever in adults." | 9.14 | A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults. ( Arons, MM; Guntupalli, KK; Morris, PE; Promes, JT; Wright, PE, 2010) |
| "Because some febrile patients are unable to swallow or retain oral antipyretic drugs, we carried out a double-blind, placebo-controlled trial in which intravenous ibuprofen (IV-ibuprofen) was given to adults hospitalized with fever associated with acute uncomplicated falciparum malaria treated with oral artesunate plus mefloquine." | 9.14 | Intravenous ibuprofen (IV-ibuprofen) controls fever effectively in adults with acute uncomplicated Plasmodium falciparum malaria but prolongs parasitemia. ( Duangdee, C; Krudsood, S; Looareesuwan, S; Pothipak, N; Tangpukdee, N; Warrell, DA; Wilairatana, P, 2010) |
| "To investigate whether paracetamol (acetaminophen) plus ibuprofen are superior to either drug alone for increasing time without fever and the relief of fever associated discomfort in febrile children managed at home." | 9.13 | Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial. ( Costelloe, C; Fletcher, M; Hay, AD; Hollinghurst, S; Montgomery, AA; Peters, TJ; Redmond, NM, 2008) |
| "According to this study: In children younger than age two, treatment with ibuprofen was associated with reduced fever and less pain within the first 24 hours compared with acetaminophen." | 9.12 | Ibuprofen Better than Acetaminophen for Reducing Fever, Pain in Young Children. ( Rosenberg, K, 2021) |
| "5 mg/kg per dose) and ibuprofen (5 mg/kg per dose) every 4 hours for 3 days, regardless of the initial loading medication, is more effective than monotherapy in lowering fever in infants and children." | 9.12 | Antipyretic treatment in young children with fever: acetaminophen, ibuprofen, or both alternating in a randomized, double-blind study. ( Cohen, HA; Sarrell, EM; Wielunsky, E, 2006) |
| "A randomised open label study of the combined use of paracetamol and ibuprofen to rapidly reduce fever is reported." | 9.12 | Randomised controlled trial of combined paracetamol and ibuprofen for fever. ( Benger, JR; Chinnick, PJ; Coppens, K; Davies, P; Erlewyn-Lajeunesse, MD; Higginson, IM; Hunt, LP, 2006) |
| "Children from the age of 3 months to 12 years with a fever of non-serious origin were randomized to receive either ibuprofen or paracetamol." | 9.12 | Ibuprofen versus paracetamol in pediatric fever: objective and subjective findings from a randomized, blinded study. ( Autret-Leca, E; Gibb, IA; Goulder, MA, 2007) |
| " In a previous randomized trial we observed that treatment with high-dose acetaminophen (paracetamol) led to a reduction of body temperature in patients with acute ischemic stroke, even when they had no fever." | 9.10 | Effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute ischemic stroke PISA, a phase II double-blind, randomized, placebo-controlled trial [ISRCTN98608690]. ( Dippel, DW; Kappelle, LJ; Koudstaal, PJ; Meijer, RJ; van Breda, EJ; van der Worp, HB; van Gemert, HM, 2003) |
| "Rather than supporting the hypothesis that ibuprofen increases asthma morbidity among children who are not known to be sensitive to aspirin or other nonsteroidal antiinflammatory drugs, these data suggest that compared with acetaminophen, ibuprofen may reduce such risks." | 9.10 | Asthma morbidity after the short-term use of ibuprofen in children. ( Lesko, SM; Louik, C; Mitchell, AA; Vezina, RM, 2002) |
| " Most importantly, we wanted to report the effect of ibuprofen treatment on vital signs, organ failure, and mortality in hypothermic sepsis." | 9.09 | Effects of ibuprofen on the physiology and survival of hypothermic sepsis. Ibuprofen in Sepsis Study Group. ( Arons, MM; Bernard, GR; Christman, BW; Dupont, WD; Fulkerson, W; Russell, JA; Schein, R; Steinberg, KP; Summer, WR; Swindell, BB; Wheeler, AP; Wright, P, 1999) |
| " The role of COX-2 in the genesis of fever in monkeys and humans was examined with use of the specific COX-2 inhibitor rofecoxib." | 9.09 | Cyclooxygenase-2 inhibition by rofecoxib reverses naturally occurring fever in humans. ( Adcock, S; Bachmann, KA; Chan, CC; Cohen, RA; Davidson, MH; Dobratz, D; Gertz, BJ; Grasing, K; Hedges, J; Jones, TM; McBride, KJ; Moritz, C; Mukhopadhyay, S; Schwartz, JI, 1999) |
| "The aim of this study was to assess and compare the efficacy and tolerability of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections (URTIs)." | 9.09 | Assessment of the efficacy and safety of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections. ( Cin, S; Köksal, Y; Ulukol, B, 1999) |
| "5 mg/kg per dose), aspirin (10 mg/kg/dose) and paracetamol (10 mg/kg per dose) on children with fever aged 6-24 months in an open, randomised study with three parallel groups." | 9.08 | Evaluation of ibuprofen versus aspirin and paracetamol on efficacy and comfort in children with fever. ( Autret, E; Courcier, S; Goehrs, JM; Henry-Launois, B; Laborde, C; Languillat, G; Launois, R; Reboul-Marty, J, 1997) |
| "In the ibuprofen group, but not the placebo group, there were significant declines in urinary levels of prostacyclin and thromboxane, temperature, heart rate, oxygen consumption, and lactic acidosis." | 9.08 | The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group. ( Bernard, GR; Christman, BW; Dupont, WD; Fulkerson, WJ; Higgins, SB; Russell, JA; Schein, R; Steinberg, KP; Summer, WR; Swindell, BB; Wheeler, AP; Wright, PE, 1997) |
| "kg-1 acetaminophen syrup (n = 77) in 154 children (6 months to 5 years) with fever (> or = 38 degrees C) associated with infectious diseases and treated with antibiotic therapy." | 9.07 | Comparative efficacy and tolerance of ibuprofen syrup and acetaminophen syrup in children with pyrexia associated with infectious diseases and treated with antibiotics. ( Autret, E; Breart, G; Courcier, S; Goehrs, JM; Jonville, AP; Lassale, C, 1994) |
| "Amphotericin B produces chills and fever in a significant proportion of patients who receive this drug." | 9.06 | Induction of prostaglandin synthesis as the mechanism responsible for the chills and fever produced by infusing amphotericin B. ( Gigliotti, F; Lott, L; Shenep, JL; Thornton, D, 1987) |
| "Acetaminophen (paracetamol) and ibuprofen are the most widely prescribed and available over-the-counter medications for management of fever and pain in children." | 9.05 | Comparison of Acetaminophen (Paracetamol) With Ibuprofen for Treatment of Fever or Pain in Children Younger Than 2 Years: A Systematic Review and Meta-analysis. ( Braithwaite, I; Dalziel, SR; McKinlay, CJD; Tan, E, 2020) |
| "The antipyretic activity of ibuprofen and aspirin was compared in sixteen children with pyrexia due to upper respiratory tract infection and in twelve with fever due to other causes." | 9.05 | Comparative evaluation of antipyretic activity of ibuprofen and aspirin in children with pyrexia of varied aetiology. ( Joshi, MK; Joshi, VR; Kandoth, PW; Satoskar, RS, 1984) |
| "In a study of the antipyretic effect of two dosage levels of ibuprofen syrup in children with fever due to a variety of causes, forty-four out of the fifty children admitted completed the 24-hour trial period, twenty-three receiving 20 mg ibuprofen/kg body-weight, twenty-one receiving 30 mg/kg ibuprofen." | 9.05 | A comparative study of two dosage levels of ibuprofen syrup in children with pyrexia. ( Kotob, A, 1985) |
| "Our primary objective was to assess the effectiveness of paracetamol (acetaminophen) or NSAIDs, alone or combined, compared with placebo or no treatment in relieving pain in children with AOM." | 8.93 | Paracetamol (acetaminophen) or non-steroidal anti-inflammatory drugs, alone or combined, for pain relief in acute otitis media in children. ( Damoiseaux, RA; Hay, AD; Little, P; Schilder, AG; Sjoukes, A; van de Pol, AC; Venekamp, RP, 2016) |
| "Combination treatment with ibuprofen and acetaminophen is beneficial over either agent alone for sustained fever reduction in children older than 6 months." | 8.89 | Does combination treatment with ibuprofen and acetaminophen improve fever control? ( Malya, RR, 2013) |
| " For many years, ketorolac was the only intravenous NSAID available in the US, but in 2009 intravenous ibuprofen was approved by the US FDA for the treatment of pain and fever in adults." | 8.88 | Pharmacokinetics of intravenous ibuprofen: implications of time of infusion in the treatment of pain and fever. ( Smith, HS; Voss, B, 2012) |
| "To analyse major sources of evidence-based information on the efficacy and gastrointestinal tolerability of aspirin, used short-term, in over-the-counter (OTC) doses, to relieve acute pain and cold symptoms, including associated feverishness." | 8.88 | Efficacy and gastrointestinal risk of aspirin used for the treatment of pain and cold. ( McCarthy, DM, 2012) |
| "Acetylsalicylic acid (ASA [aspirin]) is a commonly used over-the-counter drug for the treatment of pain, fever, or colds, but data on the safety of this use are very limited." | 8.87 | Short-term acetylsalicylic acid (aspirin) use for pain, fever, or colds - gastrointestinal adverse effects: a meta-analysis of randomized clinical trials. ( Baron, JA; Brueckner, A; Lanas, A; McCarthy, D; Senn, S; Voelker, M, 2011) |
| "Paracetamol and ibuprofen are safe and effective medications for reducing a fever in children and young people and they are often administered together with a view to reducing a temperature quickly." | 8.86 | Fever management: evaluating the use of ibuprofen and paracetamol. ( Crook, J, 2010) |
| "Although many studies have investigated the safety and tolerability of ibuprofen or acetaminophen (paracetamol) use in children, few have specifically examined the association of ibuprofen or acetaminophen and the occurrence of asthma in pediatric populations." | 8.84 | A review of ibuprofen and acetaminophen use in febrile children and the occurrence of asthma-related symptoms. ( Dale, S; Kanabar, D; Rawat, M, 2007) |
| "To summarize studies testing the efficacy and safety of single-dose acetaminophen and ibuprofen for treating children's pain or fever." | 8.82 | Efficacy and safety of acetaminophen vs ibuprofen for treating children's pain or fever: a meta-analysis. ( Champion, GD; Goodenough, B; Perrott, DA; Piira, T, 2004) |
| "to compare the antipyretic effects of ibuprofen in febrile children with serious bacterial infections (SBI), and children with a presumed viral infection." | 8.02 | Fever response to ibuprofen in viral and bacterial childhood infections. ( Barkan Perl, S; Breitbart, R; Gamsu, S; Gelernter, R; Goldman, M; Kozer, E; Lazarovitch, Z; Ophir, N; Oren-Amit, A; Youngster, I, 2021) |
| "A healthy 15-year-old boy presented to the emergency department with headache, nausea, dizziness, fever, conjunctival hyperemia and blurred vision 30 minutes after ibuprofen-intake." | 7.91 | IBUPROFEN-INDUCED ASEPTIC MENINGITIS: A CASE REPORT. ( Agro, JPSEABD; Lemos, AP; Maia, PADSV; Pereira, EPMN; Pires, SAP, 2019) |
| " Drug lymphocyte stimulation tests implicated ibuprofen, a main component of the OTC drugs, which has the potential to induce this pathology, and a diagnosis of drug-induced liver injury with multiform exudative erythema was made." | 7.81 | Drug-induced liver injury with serious multiform exudative erythema following the use of an over-the-counter medication containing ibuprofen. ( Abe, M; Aritomo, K; Hiasa, Y; Hirooka, M; Ikeda, Y; Koizumi, Y; Kumagi, T; Matsuura, B; Ochi, H; Tada, F; Tokumoto, Y; Watanabe, T, 2015) |
| "Children who have unresolved pain despite the use of either ibuprofen or acetaminophen should have their medication regimen reviewed to ensure they are receiving the medication at an adequate dose and interval." | 7.78 | Alternating acetaminophen and ibuprofen for pain in children. ( Goldman, RD; Smith, C, 2012) |
| "Seventy-five (3 x 25) patients with acute ischaemic stroke confined to the anterior circulation will be randomised to treatment with either: 400 mg ibuprofen, 1000 mg acetaminophen, or with placebo 6 times daily during 5 days." | 7.71 | PISA. The effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute stroke: protocol for a phase II double-blind randomised placebo-controlled trial [ISRCTN98608690]. ( Dippel, DW; Kappelle, J; Koudstaal, PJ; Meijer, R; van Breda, EJ; van der Worp, B; van Gemert, M, 2002) |
| "Fever is a common symptom in children and one of the major concerns of parents of younger and preschool-age children." | 6.75 | Ketoprofen versus paracetamol (acetaminophen) or ibuprofen in the management of fever: results of two randomized, double-blind, double-dummy, parallel-group, repeated-dose, multicentre, phase III studies in children. ( Kokki, H; Kokki, M, 2010) |
| "At physician-directed dosing (acetaminophen 15 mg/kg vs ibuprofen 10 mg/kg), no significant differences in antipyretic effects from 0‒6 h and between 0‒6, ‒12, ‒24, or ‒48 h, with single or multiple-doses, respectively, were observed." | 6.72 | Acetaminophen and ibuprofen in the treatment of pediatric fever: a narrative review. ( Paul, IM; Walson, PD, 2021) |
| "Ibuprofen liquid was given as a single dose, 5 mg/kg to 18 patients (group I) and 10 mg/kg to 18 patients (group II); placebo was administered to 20 patients (group III)." | 6.67 | Efficacy of ibuprofen in pediatric patients with fever. ( Durrell, DE; Gupta, N; Miller, MA; Nahata, MC; Powell, DA, 1992) |
| "Ibuprofen, paracetamol and placebo have similar tolerability and safety profiles in terms of gastrointestinal symptoms, asthma and renal adverse effects." | 6.45 | Systematic review and meta-analysis of the clinical safety and tolerability of ibuprofen compared with paracetamol in paediatric pain and fever. ( Kleijnen, J; Soares-Weiser, K; Southey, ER, 2009) |
| "Fever has been reported as a common symptom occurring in COVID-19 illness." | 5.56 | The use of ibuprofen to treat fever in COVID-19: A possible indirect association with worse outcome? ( Haryadi, TH; Jamerson, BD, 2020) |
| " The Paracetamol and Ibuprofen in the Primary Prevention of Asthma in Tamariki (PIPPA Tamariki) trial is an open-label, randomised controlled trial aiming to determine whether paracetamol treatment, compared with ibuprofen treatment, as required for fever and pain in the first year of life, increases the risk of asthma at age six years." | 5.51 | Panic or peace - prioritising infant welfare when medicating feverish infants: a grounded theory study of adherence in a paediatric clinical trial. ( Braithwaite, I; Dalziel, SR; Fernando, K; Haskell, L; Hoare, K; McKinlay, CJ; Riley, J; Tan, E, 2022) |
| " Eligible children will receive treatment allocation randomization either to standard of care for fever management or to prophylactic, scheduled treatment every 6 hours for 72 hours with dual antipyretic therapies using acetaminophen and ibuprofen." | 5.51 | Aggressive antipyretics in central nervous system malaria: Study protocol of a randomized-controlled trial assessing antipyretic efficacy and parasite clearance effects (Malaria FEVER study). ( Birbeck, GL; Chilombe, MB; Mathews, M; McDermott, MP; Mwenechanya, M; Seydel, KB, 2022) |
| "This study aims to evaluate the efficacy and safety of multiple or single-dosage intravenous ibuprofen (IVIB) in managing postoperative pain and fever in adults who are unable to take oral medications." | 5.41 | Intravenous ibuprofen in postoperative pain and fever management in adults: A systematic review and meta-analysis of randomized controlled trials. ( Chen, L; He, L; Tian, S; Wang, E; Zhai, S; Zhou, P, 2023) |
| "Our primary objective was to assess the effectiveness of paracetamol (acetaminophen) or NSAIDs, alone or combined, compared with placebo or no treatment in relieving pain in children with AOM." | 5.41 | Paracetamol (acetaminophen) or non-steroidal anti-inflammatory drugs, alone or combined, for pain relief in acute otitis media in children. ( Damoiseaux, RA; de Sévaux, JLH; Hay, AD; Little, P; Lutje, V; Schilder, AG; van de Pol, AC; Venekamp, RP, 2023) |
| "In adult age group patients admitted to the emergency department with high fever, the IV forms of 1000 mg paracetamol and 400 mg ibuprofen effectively and equally reduce complaints, such as fever and accompanying pain." | 5.41 | Comparison of intravenous ibuprofen and paracetamol in the treatment of fever: A randomized double-blind study. ( Can, Ö; Kıyan, GS; Yalçınlı, S, 2021) |
| "Ibuprofen is a well established analgesic, anti-inflammatory and antipyretic NSAID." | 5.38 | Intravenous ibuprofen: in adults for pain and fever. ( Scott, LJ, 2012) |
| "the overall result showed that ibuprofen had a better fever reducing effect compared to paracetamol." | 5.34 | Ibuprofen versus paracetamol for treating fever in preschool children in Nigeria: a randomized clinical trial of effectiveness and safety. ( Akande, PA; Alaje, EO; Meremikwu, MM; Odey, FA; Udoh, EE, 2020) |
| "He had an upper respiratory tract infection in which a vaso-occlusive crisis was precipitated." | 5.34 | Tramadol infusion for the pain management in sickle cell disease: a case report. ( Aydinok, Y; Balkan, C; Erhan, E; Inal, MT; Yegul, I, 2007) |
| "We here present the case of a patient with severe neutropenia, haemolytic anaemia and thrombocytopenia associated with long-term use of ibuprofen." | 5.28 | A case of severe pancytopenia caused by ibuprofen. ( Lindblad, R; Rödjer, S, 1991) |
| "We aimed to compare the antipyretic efficacy, safety, and tolerability between oral dexibuprofen and intravenous propacetamol in children with upper respiratory tract infection (URTI) presenting with fever." | 5.27 | The antipyretic efficacy and safety of propacetamol compared with dexibuprofen in febrile children: a multicenter, randomized, double-blind, comparative, phase 3 clinical trial. ( Choi, SJ; Choi, UY; Chun, YH; Jeong, DC; Kim, HM; Lee, J; Lee, JH; Moon, S; Rhim, JW, 2018) |
| "A 21-year-old woman with systemic lupus erythematosus (SLE) had meningismus, conjunctivitis, lymphadenopathy, and elevation of liver function values following ibuprofen therapy." | 5.26 | Tolmetin-induced aseptic meningitis. ( Barth, WF; Ruppert, GB, 1981) |
| "No evidence can be found in the medical literature about the efficacy of alternating acetaminophen and ibuprofen treatment in children with refractory fever." | 5.24 | Alternating Acetaminophen and Ibuprofen versus Monotherapies in Improvements of Distress and Reducing Refractory Fever in Febrile Children: A Randomized Controlled Trial. ( Guo, Q; Luo, Q; Luo, S; Ran, M; Shu, M; Wan, C; Xie, X; Zhang, C; Zhu, Y, 2017) |
| "Two blinded single-dose studies randomized children 6 months to 11 years old with fever to receive ibuprofen (IBU) pediatric suspension 7." | 5.24 | Antipyretic Efficacy and Safety of Ibuprofen Versus Acetaminophen Suspension in Febrile Children: Results of 2 Randomized, Double-Blind, Single-Dose Studies. ( Jayawardena, S; Kellstein, D, 2017) |
| "001); in a greater reduction in change from baseline temperature compared to treatment with acetaminophen, and it reduced fever throughout a 24 h dosing period." | 5.24 | A multicenter, randomized, open-label, active-comparator trial to determine the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for treatment of fever in hospitalized pediatric patients. ( Chumpitazi, CE; Hahn, BJ; Kaelin, BA; Khalil, SN; Macias, CG; Rock, AD, 2017) |
| "To evaluate ibuprofen and acetaminophen in the treatment of infectious fever in children." | 5.22 | Comparison between Ibuprofen and Acetaminophen in the Treatment of Infectious Fever in Children: A Meta-Analysis. ( Guo, H; Liu, Y; Yin, F, 2022) |
| "Studies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking." | 5.22 | Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma. ( Bacharier, LB; Baxi, SN; Beigelman, A; Benson, M; Blake, K; Boehmer, SJ; Cabana, MD; Chmiel, JF; Covar, R; Daines, CL; Daines, MO; Fitzpatrick, AM; Gaffin, JM; Gentile, DA; Gower, WA; Holguin, F; Israel, E; Jackson, DJ; Kumar, HV; Lang, JE; Lazarus, SC; Lemanske, RF; Lima, JJ; Ly, N; Marbin, J; Martinez, FD; Mauger, DT; Morgan, WJ; Moy, JN; Myers, RE; Olin, JT; Paul, IM; Peters, SP; Phipatanakul, W; Pongracic, JA; Raissy, HH; Robison, RG; Ross, K; Sheehan, WJ; Sorkness, CA; Szefler, SJ; Thyne, SM; Wechsler, ME, 2016) |
| "The main purpose of the study was to determine the safety profile and efficacy of intravenous ibuprofen administered over 5 to 10 minutes for the treatment of pain or fever in hospitalized patients." | 5.20 | The shortened infusion time of intravenous ibuprofen part 1: a multicenter, open-label, surveillance trial to evaluate safety and efficacy. ( Ayad, SS; Bergese, SD; Candiotti, K; Gan, TJ; Soghomonyan, S, 2015) |
| "To establish the relative clinical effectiveness and cost-effectiveness of paracetamol plus ibuprofen compared with paracetamol and ibuprofen separately for time without fever, and the relief of fever-associated discomfort in young children who can be managed at home." | 5.14 | Paracetamol and ibuprofen for the treatment of fever in children: the PITCH randomised controlled trial. ( Costelloe, C; Fletcher, M; Hay, AD; Hollinghurst, S; Montgomery, AA; Peters, TJ; Redmond, NM, 2009) |
| "Hospitalized patients are often unable to ingest or tolerate oral antipyretics and recently an aqueous formulation of intravenous (IV) ibuprofen was approved by the US-FDA for the reduction of fever in adults." | 5.14 | A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults. ( Arons, MM; Guntupalli, KK; Morris, PE; Promes, JT; Wright, PE, 2010) |
| "Because some febrile patients are unable to swallow or retain oral antipyretic drugs, we carried out a double-blind, placebo-controlled trial in which intravenous ibuprofen (IV-ibuprofen) was given to adults hospitalized with fever associated with acute uncomplicated falciparum malaria treated with oral artesunate plus mefloquine." | 5.14 | Intravenous ibuprofen (IV-ibuprofen) controls fever effectively in adults with acute uncomplicated Plasmodium falciparum malaria but prolongs parasitemia. ( Duangdee, C; Krudsood, S; Looareesuwan, S; Pothipak, N; Tangpukdee, N; Warrell, DA; Wilairatana, P, 2010) |
| "Many pediatricians recommend, and many parents administer, alternating or combined doses of ibuprofen and acetaminophen for fever." | 5.14 | Efficacy of standard doses of Ibuprofen alone, alternating, and combined with acetaminophen for the treatment of febrile children. ( Berlin, CM; Engle, L; Paul, IM; Sturgis, SA; Watts, H; Yang, C, 2010) |
| "Methods A prospective, randomized double-blind placebo control study comparing the efficacy of acetaminophen to acetaminophen alternated with ibuprofen in 38 healthy outpatient children 6 months to 6 years presenting to the outpatient clinic with fever >38 degrees C was conducted." | 5.13 | Alternating antipyretics: antipyretic efficacy of acetaminophen versus acetaminophen alternated with ibuprofen in children. ( Fairchok, MP; Harper, DP; Kramer, LC; Richards, PA; Thompson, AM, 2008) |
| "To investigate whether paracetamol (acetaminophen) plus ibuprofen are superior to either drug alone for increasing time without fever and the relief of fever associated discomfort in febrile children managed at home." | 5.13 | Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial. ( Costelloe, C; Fletcher, M; Hay, AD; Hollinghurst, S; Montgomery, AA; Peters, TJ; Redmond, NM, 2008) |
| "In the clinical trial of the antipyretic action of dexibuprofen in patients with fever caused by URTI, there was no statistically significant difference in maximal decrease of temperature and mean time to become apyrexial among the 5 mg kg(-1) dexibuprofen, 7 mg kg(-1) dexibuprofen and 10 mg kg(-1) ibuprofen groups (P > 0." | 5.13 | The effects and safety of dexibuprofen compared with ibuprofen in febrile children caused by upper respiratory tract infection. ( Jeong, DC; Kang, JH; Kim, JT; Koh, YY; Lee, HS; Lee, JS; Lee, KY; Oh, JW; Yoon, JS, 2008) |
| "According to this study: In children younger than age two, treatment with ibuprofen was associated with reduced fever and less pain within the first 24 hours compared with acetaminophen." | 5.12 | Ibuprofen Better than Acetaminophen for Reducing Fever, Pain in Young Children. ( Rosenberg, K, 2021) |
| "5 mg/kg per dose) and ibuprofen (5 mg/kg per dose) every 4 hours for 3 days, regardless of the initial loading medication, is more effective than monotherapy in lowering fever in infants and children." | 5.12 | Antipyretic treatment in young children with fever: acetaminophen, ibuprofen, or both alternating in a randomized, double-blind study. ( Cohen, HA; Sarrell, EM; Wielunsky, E, 2006) |
| "A randomised open label study of the combined use of paracetamol and ibuprofen to rapidly reduce fever is reported." | 5.12 | Randomised controlled trial of combined paracetamol and ibuprofen for fever. ( Benger, JR; Chinnick, PJ; Coppens, K; Davies, P; Erlewyn-Lajeunesse, MD; Higginson, IM; Hunt, LP, 2006) |
| "Children from the age of 3 months to 12 years with a fever of non-serious origin were randomized to receive either ibuprofen or paracetamol." | 5.12 | Ibuprofen versus paracetamol in pediatric fever: objective and subjective findings from a randomized, blinded study. ( Autret-Leca, E; Gibb, IA; Goulder, MA, 2007) |
| "To determine whether evidence in the medical literature supports ibuprofen or acetaminophen for reducing fever in children." | 5.11 | The antipyretic effect of ibuprofen and acetaminophen in children. ( Wahba, H, 2004) |
| "One hundred and three cases of postopterative pain and 60 cases of fever, altogether 163 patients were randomly divided into 2 groups: S (+) -ismer of ibuprofen supporsitory treatment group (one supporsitory per day for 3 days) and ibuprofen supporsitory treatment group (one supporsitory per day for 3 days)." | 5.11 | [Randomized controlled study of S (+) -ismer of ibuprofen supporsitory]. ( Gao, JS; Huang, AL; Luo, H; Wu, CL; You, YH, 2004) |
| " In a previous randomized trial we observed that treatment with high-dose acetaminophen (paracetamol) led to a reduction of body temperature in patients with acute ischemic stroke, even when they had no fever." | 5.10 | Effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute ischemic stroke PISA, a phase II double-blind, randomized, placebo-controlled trial [ISRCTN98608690]. ( Dippel, DW; Kappelle, LJ; Koudstaal, PJ; Meijer, RJ; van Breda, EJ; van der Worp, HB; van Gemert, HM, 2003) |
| "Rather than supporting the hypothesis that ibuprofen increases asthma morbidity among children who are not known to be sensitive to aspirin or other nonsteroidal antiinflammatory drugs, these data suggest that compared with acetaminophen, ibuprofen may reduce such risks." | 5.10 | Asthma morbidity after the short-term use of ibuprofen in children. ( Lesko, SM; Louik, C; Mitchell, AA; Vezina, RM, 2002) |
| " Most importantly, we wanted to report the effect of ibuprofen treatment on vital signs, organ failure, and mortality in hypothermic sepsis." | 5.09 | Effects of ibuprofen on the physiology and survival of hypothermic sepsis. Ibuprofen in Sepsis Study Group. ( Arons, MM; Bernard, GR; Christman, BW; Dupont, WD; Fulkerson, W; Russell, JA; Schein, R; Steinberg, KP; Summer, WR; Swindell, BB; Wheeler, AP; Wright, P, 1999) |
| " The role of COX-2 in the genesis of fever in monkeys and humans was examined with use of the specific COX-2 inhibitor rofecoxib." | 5.09 | Cyclooxygenase-2 inhibition by rofecoxib reverses naturally occurring fever in humans. ( Adcock, S; Bachmann, KA; Chan, CC; Cohen, RA; Davidson, MH; Dobratz, D; Gertz, BJ; Grasing, K; Hedges, J; Jones, TM; McBride, KJ; Moritz, C; Mukhopadhyay, S; Schwartz, JI, 1999) |
| "To compare the incidence of serious adverse clinical events among children <2 years old given ibuprofen and acetaminophen to control fever." | 5.09 | The safety of acetaminophen and ibuprofen among children younger than two years old. ( Lesko, SM; Mitchell, AA, 1999) |
| "The aim of this study was to assess and compare the efficacy and tolerability of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections (URTIs)." | 5.09 | Assessment of the efficacy and safety of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections. ( Cin, S; Köksal, Y; Ulukol, B, 1999) |
| "Both ibuprofen formulations were effective in reducing fever and may be considered clinically bioequivalent." | 5.09 | [Evaluation of the antipyretic safety and accuracy of two pediatric ibuprofen formulations]. ( Antelo Cortizas , J; Armenteros González , S; Díez Domingo , J; Domínguez Granados , R; Molina Carballo , A; Moreno Carretero , E; Moreno Madrid , F; Moreno Martín , J; Planelles Cantarino , MV; Uberos Fernández , J, 2000) |
| "To evaluate the effects of endotoxemia on respiratory controller function, 12 subjects were randomized to receive endotoxin or saline; six also received ibuprofen, a cyclooxygenase inhibitor, and six received placebo." | 5.09 | Effect of endotoxin on ventilation and breath variability: role of cyclooxygenase pathway. ( Banks, SM; Godin, PJ; Jubran, A; Preas, HL; Reda, D; Suffredini, AF; Tobin, MJ; Vandivier, RW, 2001) |
| "This study compared the antipyretic effectiveness of acetaminophen, ibuprofen, and dipyrone in young children with fever." | 5.09 | Antipyretic effects of dipyrone versus ibuprofen versus acetaminophen in children: results of a multinational, randomized, modified double-blind study. ( Barragán, S; Campos, S; De León González, M; Escobar, AM; Ferrero, F; Kesselring, GL; Plager, M; Santolaya, ME; Sibbald, A; Wong, A, 2001) |
| "5 mg/kg per dose), aspirin (10 mg/kg/dose) and paracetamol (10 mg/kg per dose) on children with fever aged 6-24 months in an open, randomised study with three parallel groups." | 5.08 | Evaluation of ibuprofen versus aspirin and paracetamol on efficacy and comfort in children with fever. ( Autret, E; Courcier, S; Goehrs, JM; Henry-Launois, B; Laborde, C; Languillat, G; Launois, R; Reboul-Marty, J, 1997) |
| "In the ibuprofen group, but not the placebo group, there were significant declines in urinary levels of prostacyclin and thromboxane, temperature, heart rate, oxygen consumption, and lactic acidosis." | 5.08 | The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group. ( Bernard, GR; Christman, BW; Dupont, WD; Fulkerson, WJ; Higgins, SB; Russell, JA; Schein, R; Steinberg, KP; Summer, WR; Swindell, BB; Wheeler, AP; Wright, PE, 1997) |
| " Children with a febrile illness were enrolled from outpatient pediatric and family medicine practices and randomly assigned to receive either acetaminophen suspension or one of two dosages of ibuprofen suspension (5 mg/kg or 10 mg/kg) for fever control." | 5.08 | Renal function after short-term ibuprofen use in infants and children. ( Lesko, SM; Mitchell, AA, 1997) |
| "kg-1 acetaminophen syrup (n = 77) in 154 children (6 months to 5 years) with fever (> or = 38 degrees C) associated with infectious diseases and treated with antibiotic therapy." | 5.07 | Comparative efficacy and tolerance of ibuprofen syrup and acetaminophen syrup in children with pyrexia associated with infectious diseases and treated with antibiotics. ( Autret, E; Breart, G; Courcier, S; Goehrs, JM; Jonville, AP; Lassale, C, 1994) |
| "5-, 5-, or 10-mg/kg ibuprofen therapy via a liquid or 15-mg/kg acetaminophen therapy via an elixir every 6 hours for 24 to 48 hours show equivalent fever reduction or suffer adverse effects of the drug administered." | 5.07 | Comparison of multidose ibuprofen and acetaminophen therapy in febrile children. ( Braden, NJ; Chomilo, F; Galletta, G; Sawyer, LA; Scheinbaum, ML; Walson, PD, 1992) |
| "A double-blind, parallel-group, triple-dummy-designed, single-oral-dose study compared the efficacy, tolerability, safety, and dose-response of 5 mg/kg (n = 32) and 10 mg/kg (n = 28) ibuprofen suspension, 10 mg/kg acetaminophen elixir (n = 33), and placebo liquids (n = 34) in 127 children (2 to 11 years of age) with fever (101 degrees to 104 degrees F)." | 5.06 | Ibuprofen, acetaminophen, and placebo treatment of febrile children. ( Alexander, L; Braden, NJ; Galletta, G; Walson, PD, 1989) |
| "Amphotericin B produces chills and fever in a significant proportion of patients who receive this drug." | 5.06 | Induction of prostaglandin synthesis as the mechanism responsible for the chills and fever produced by infusing amphotericin B. ( Gigliotti, F; Lott, L; Shenep, JL; Thornton, D, 1987) |
| "Acetaminophen (paracetamol) and ibuprofen are the most widely prescribed and available over-the-counter medications for management of fever and pain in children." | 5.05 | Comparison of Acetaminophen (Paracetamol) With Ibuprofen for Treatment of Fever or Pain in Children Younger Than 2 Years: A Systematic Review and Meta-analysis. ( Braithwaite, I; Dalziel, SR; McKinlay, CJD; Tan, E, 2020) |
| "The antipyretic activity of ibuprofen and aspirin was compared in sixteen children with pyrexia due to upper respiratory tract infection and in twelve with fever due to other causes." | 5.05 | Comparative evaluation of antipyretic activity of ibuprofen and aspirin in children with pyrexia of varied aetiology. ( Joshi, MK; Joshi, VR; Kandoth, PW; Satoskar, RS, 1984) |
| "In a study of the antipyretic effect of two dosage levels of ibuprofen syrup in children with fever due to a variety of causes, forty-four out of the fifty children admitted completed the 24-hour trial period, twenty-three receiving 20 mg ibuprofen/kg body-weight, twenty-one receiving 30 mg/kg ibuprofen." | 5.05 | A comparative study of two dosage levels of ibuprofen syrup in children with pyrexia. ( Kotob, A, 1985) |
| "- Paracetamol or ibuprofen should only be given when there is a combination of fever and pain." | 4.95 | [Revision of the Dutch College of General Practitioners practice guideline 'Children with fever']. ( Eizenga, WE; Opstelten, W, 2017) |
| " Paracetamol and ibuprofen are the most commonly used interventions to manage fever in children; however, there have been no comparative analyses." | 4.95 | Effectiveness of paracetamol versus ibuprofen administration in febrile children: A systematic literature review. ( Cooper, S; Innes, K; Morphet, J; Narayan, K, 2017) |
| "Ibuprofen is a non-steroidal anti-inflammatory drug frequently administered to children of various ages for relief of fever and pain and is approved as an over-the-counter medication in many countries worldwide." | 4.95 | Efficacy and Safety of Ibuprofen in Infants Aged Between 3 and 6 Months. ( Erb, TO; van den Anker, JN; Ziesenitz, VC; Zutter, A, 2017) |
| "Ibuprofen is the most widely used non-steroidal anti-inflammatory drug (NSAID) for the treatment of inflammation, mild-to-moderate pain and fever in children, and is the only NSAID approved for use in children aged ≥3 months." | 4.95 | Working Towards an Appropriate Use of Ibuprofen in Children: An Evidence-Based Appraisal. ( Boner, A; Chiarugi, A; de Martino, M; De' Angelis, GL; Montini, G, 2017) |
| " The aim of this review is to determine if there are any clinically relevant differences in safety between ibuprofen and paracetamol that may recommend one agent over the other in the management of fever and discomfort in children older than 3 months of age." | 4.95 | A clinical and safety review of paracetamol and ibuprofen in children. ( Kanabar, DJ, 2017) |
| "Our primary objective was to assess the effectiveness of paracetamol (acetaminophen) or NSAIDs, alone or combined, compared with placebo or no treatment in relieving pain in children with AOM." | 4.93 | Paracetamol (acetaminophen) or non-steroidal anti-inflammatory drugs, alone or combined, for pain relief in acute otitis media in children. ( Damoiseaux, RA; Hay, AD; Little, P; Schilder, AG; Sjoukes, A; van de Pol, AC; Venekamp, RP, 2016) |
| "Health professionals frequently recommend fever treatment regimens for children that either combine paracetamol and ibuprofen or alternate them." | 4.90 | Combined and alternating paracetamol and ibuprofen therapy for febrile children. ( Ganshorn, H; Hartling, L; Johnson, DW; Maconochie, IK; Stang, AS; Thomsen, AM; Wong, T, 2014) |
| "Combination treatment with ibuprofen and acetaminophen is beneficial over either agent alone for sustained fever reduction in children older than 6 months." | 4.89 | Does combination treatment with ibuprofen and acetaminophen improve fever control? ( Malya, RR, 2013) |
| "Health professionals frequently recommend fever treatment regimens for children that either combine paracetamol and ibuprofen or alternate them." | 4.89 | Combined and alternating paracetamol and ibuprofen therapy for febrile children. ( Ganshorn, H; Hartling, L; Johnson, DW; Maconochie, IK; Stang, AS; Thomsen, AM; Wong, T, 2013) |
| " In paediatric populations, ibuprofen and paracetamol (acetaminophen) are both commonly used over-the-counter medicines for the management of fever or mild-to-moderate pain associated with sore throat, otitis media, toothache, earache and headache." | 4.89 | Optimising the management of fever and pain in children. ( van den Anker, JN, 2013) |
| " For many years, ketorolac was the only intravenous NSAID available in the US, but in 2009 intravenous ibuprofen was approved by the US FDA for the treatment of pain and fever in adults." | 4.88 | Pharmacokinetics of intravenous ibuprofen: implications of time of infusion in the treatment of pain and fever. ( Smith, HS; Voss, B, 2012) |
| "To analyse major sources of evidence-based information on the efficacy and gastrointestinal tolerability of aspirin, used short-term, in over-the-counter (OTC) doses, to relieve acute pain and cold symptoms, including associated feverishness." | 4.88 | Efficacy and gastrointestinal risk of aspirin used for the treatment of pain and cold. ( McCarthy, DM, 2012) |
| "To evaluate the evidence surrounding the use of combinations of paracetamol and ibuprofen in the treatment of fever." | 4.87 | Systematic review of studies comparing combined treatment with paracetamol and ibuprofen, with either drug alone. ( Purssell, E, 2011) |
| "Acetylsalicylic acid (ASA [aspirin]) is a commonly used over-the-counter drug for the treatment of pain, fever, or colds, but data on the safety of this use are very limited." | 4.87 | Short-term acetylsalicylic acid (aspirin) use for pain, fever, or colds - gastrointestinal adverse effects: a meta-analysis of randomized clinical trials. ( Baron, JA; Brueckner, A; Lanas, A; McCarthy, D; Senn, S; Voelker, M, 2011) |
| "Ibuprofen is as or more efficacious than acetaminophen for the treatment of pain and fever in adult and pediatric populations and is equally safe." | 4.86 | Efficacy and safety of ibuprofen and acetaminophen in children and adults: a meta-analysis and qualitative review. ( Pierce, CA; Voss, B, 2010) |
| "Paracetamol and ibuprofen are safe and effective medications for reducing a fever in children and young people and they are often administered together with a view to reducing a temperature quickly." | 4.86 | Fever management: evaluating the use of ibuprofen and paracetamol. ( Crook, J, 2010) |
| "Although many studies have investigated the safety and tolerability of ibuprofen or acetaminophen (paracetamol) use in children, few have specifically examined the association of ibuprofen or acetaminophen and the occurrence of asthma in pediatric populations." | 4.84 | A review of ibuprofen and acetaminophen use in febrile children and the occurrence of asthma-related symptoms. ( Dale, S; Kanabar, D; Rawat, M, 2007) |
| "Ibuprofen is prescribed for children for the treatment of acute pain and fever, and for juvenile idiopathic arthritis." | 4.82 | A general overview of the use of ibuprofen in paediatrics. ( Autret-Leca, E, 2003) |
| "This paper describes two studies in children with fever in which the safety of ibuprofen was compared with that of paracetamol." | 4.82 | The safety of ibuprofen suspension in children. ( Lesko, SM, 2003) |
| "Ibuprofen was significantly more effective than acetaminophen in reducing fever after a single dose." | 4.82 | Antipyretic efficacy and safety of ibuprofen and acetaminophen in children. ( Goldman, RD; Ko, K; Linett, LJ; Scolnik, D, 2004) |
| "To summarize studies testing the efficacy and safety of single-dose acetaminophen and ibuprofen for treating children's pain or fever." | 4.82 | Efficacy and safety of acetaminophen vs ibuprofen for treating children's pain or fever: a meta-analysis. ( Champion, GD; Goodenough, B; Perrott, DA; Piira, T, 2004) |
| "Paracetamol 1,000 mg represents the first choice for the treatment of fever in the ED, followed by Paracetamol/Ibuprofen 500/150 mg." | 4.31 | Treatment of fever and associated symptoms in the emergency department: which drug to choose? ( Candelli, M; Carnicelli, A; Covino, M; Franceschi, F; Lorusso, C; Novelli, A; Ojetti, V; Saviano, A, 2023) |
| "to compare the antipyretic effects of ibuprofen in febrile children with serious bacterial infections (SBI), and children with a presumed viral infection." | 4.02 | Fever response to ibuprofen in viral and bacterial childhood infections. ( Barkan Perl, S; Breitbart, R; Gamsu, S; Gelernter, R; Goldman, M; Kozer, E; Lazarovitch, Z; Ophir, N; Oren-Amit, A; Youngster, I, 2021) |
| " One hundred and seventy-nine (44%) patients had fever, with 32% using paracetamol and 22% using ibuprofen, for symptom-relief." | 3.96 | Ibuprofen use and clinical outcomes in COVID-19 patients. ( Bar-Haim, A; Kozer, E; Rinott, E; Shapira, Y; Youngster, I, 2020) |
| "A healthy 15-year-old boy presented to the emergency department with headache, nausea, dizziness, fever, conjunctival hyperemia and blurred vision 30 minutes after ibuprofen-intake." | 3.91 | IBUPROFEN-INDUCED ASEPTIC MENINGITIS: A CASE REPORT. ( Agro, JPSEABD; Lemos, AP; Maia, PADSV; Pereira, EPMN; Pires, SAP, 2019) |
| " Drug lymphocyte stimulation tests implicated ibuprofen, a main component of the OTC drugs, which has the potential to induce this pathology, and a diagnosis of drug-induced liver injury with multiform exudative erythema was made." | 3.81 | Drug-induced liver injury with serious multiform exudative erythema following the use of an over-the-counter medication containing ibuprofen. ( Abe, M; Aritomo, K; Hiasa, Y; Hirooka, M; Ikeda, Y; Koizumi, Y; Kumagi, T; Matsuura, B; Ochi, H; Tada, F; Tokumoto, Y; Watanabe, T, 2015) |
| "The primary objective was to assess whether patients with a fever are treated with acetaminophen or ibuprofen more promptly than they are treated for pain." | 3.80 | Is fever treated more promptly than pain in the pediatric emergency department? ( Bair, J; Dvorkin, R; Glantz, S; Marguilies, J; Patel, H; Rosalia, A; Yens, DP, 2014) |
| "Treatment of pediatric fever is based on two main molecules, paracetamol and ibuprofen." | 3.80 | [How to treat pediatric fever in 2013 with little evidence-based?]. ( Gehri, M; Pauchard, JY, 2014) |
| "Health-care professionals frequently recommend fever treatment regimens for children who either combine paracetamol and ibuprofen or alternate them." | 3.80 | Cochrane in context: Combined and alternating paracetamol and ibuprofen therapy for febrile children. ( Ganshorn, H; Hartling, L; Johnson, DW; Maconochie, IK; Stang, AS; Thomsen, AM; Wong, T, 2014) |
| "Children who have unresolved pain despite the use of either ibuprofen or acetaminophen should have their medication regimen reviewed to ensure they are receiving the medication at an adequate dose and interval." | 3.78 | Alternating acetaminophen and ibuprofen for pain in children. ( Goldman, RD; Smith, C, 2012) |
| "This study compared the antipyretic effects of ibuprofen and indomethacin regarding the efficacy in blocking fevers induced by lipopolysaccharide (LPS from E." | 3.77 | Cyclooxygenase-independent mechanism of ibuprofen-induced antipyresis: the role of central vasopressin V₁ receptors. ( Cristofoletti, R; Fabricio, AS; Lindsey, CJ; Melo, MC; Soares, DM; Souza, GE; Veiga-Souza, FH, 2011) |
| "Ibuprofen was the first of a new breed of NSAIDs originally introduced into the United Kingdom in 1969." | 3.76 | Update on ibuprofen: review article. ( Busson, M, 1986) |
| " IBU blocked LPS-induced fever but did not block LPS-induced increases in plasma cytokines and corticosterone in the pregnant dam." | 3.75 | Effects of prenatal immune activation on hippocampal neurogenesis in the rat. ( Ashdown, H; Boksa, P; Cui, K; Luheshi, GN, 2009) |
| "To report Australian parents' medication (paracetamol, ibuprofen and homeopathic) use in childhood fever management." | 3.74 | Over-the-counter medication use for childhood fever: a cross-sectional study of Australian parents. ( Edwards, H; Fraser, J; Walsh, A, 2007) |
| " However, due to its side effects, ibuprofen should be used only in high and badly tolerated fever that is not altered by a well conducted acetaminophen monotherapy." | 3.73 | [Familial use of ibuprofen in febrile children: a prospective study in the emergency room of an hospital in Lille]. ( Charkaluk, ML; El Kohen, R; Kalach, N; Kremp, O, 2005) |
| "The results of this survey concerning antipyretic treatment of children by their Jewish and Bedouin Moslem caregivers suggest that lighter body weight and the use of acetaminophen rectal suppositories were associated with the administration of higher-than-recommended doses of acetaminophen." | 3.73 | Determinants of antipyretic misuse in children up to 5 years of age: a cross-sectional study. ( Bilenko, N; Gorodischer, R; Okbe, R; Press, J; Tessler, H, 2006) |
| " Nonetheless, these data suggest that parents use ibuprofen or ibuprofen together with acetaminophen to treat high fever and severe illness, which seems to identify children at high risk for invasive GAS infection." | 3.71 | Invasive group A streptococcal infection and nonsteroidal antiinflammatory drug use among children with primary varicella. ( Lesko, SM; Mitchell, AA; O'Brien, KL; Schwartz, B; Vezina, R, 2001) |
| " Predictive factors of this practice among pediatricians are male sex, having relatively little experience, considering ibuprofen as the drug of choice and recommending the administration of new doses of antipyretic to control mild fever." | 3.71 | [Use of alternating antipyretics in the treatment of fever in Spain]. ( Ballester Sanz, A; Burgos Ramírez, A; Díez Domingo, J; Garrido García, J; Moreno Carretero, E, 2001) |
| "Seventy-five (3 x 25) patients with acute ischaemic stroke confined to the anterior circulation will be randomised to treatment with either: 400 mg ibuprofen, 1000 mg acetaminophen, or with placebo 6 times daily during 5 days." | 3.71 | PISA. The effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute stroke: protocol for a phase II double-blind randomised placebo-controlled trial [ISRCTN98608690]. ( Dippel, DW; Kappelle, J; Koudstaal, PJ; Meijer, R; van Breda, EJ; van der Worp, B; van Gemert, M, 2002) |
| " To assess the role of MIP-1alpha and MIP-1beta in human inflammation, healthy subjects were studied during experimental endotoxemia with prior administration of ibuprofen, a cyclooxygenase inhibitor, or dimeric p75 tumor necrosis factor (TNF)-alpha receptor, a TNF antagonist; septic patients were also studied." | 3.70 | Detection of macrophage inflammatory protein (MIP)-1alpha and MIP-1beta during experimental endotoxemia and human sepsis. ( Banks, SM; O'Grady, NP; Preas, HL; Reda, D; Suffredini, AF; Tropea, M; Vandivier, RW, 1999) |
| "Ibuprofen is effective in the treatment of fever in children." | 3.70 | [Analysis of prognostic factors for the antipyretic response to ibuprofen]. ( , 2000) |
| " The anti-inflammatory potency of NS-398 in rat carrageenin-induced edema was as potent as that of indomethacin and 8 times more potent than diclofenac." | 3.68 | NS-398, a novel non-steroidal anti-inflammatory drug with potent analgesic and antipyretic effects, which causes minimal stomach lesions. ( Arai, I; Futaki, N; Hamasaka, Y; Higuchi, S; Iizuka, H; Otomo, S; Yoshikawa, K, 1993) |
| "Ibuprofen may be an alternative to acetaminophen to control fever in children but little is known about its pharmacokinetics in pediatric patients." | 3.68 | Pharmacokinetics of ibuprofen in febrile children. ( Durrell, DE; Gupta, N; Nahata, MC; Powell, DA, 1991) |
| "Three young women with systemic lupus erythematosus who were given ibuprofen for arthritis voluntarily discontinued taking the drug." | 3.66 | Acute adverse reactions to ibuprofen in systemic lupus erythematosus. ( Finch, WR; Strottman, MP, 1979) |
| "The capacity of ibuprofen to reduce fever in children was compared with that of aspirin, paracetamol, aminophenazone and indomethacin." | 3.65 | Oral antipyretic therapy. ( Keinänen, S; Kouvalainen, K; Similä, S, 1976) |
| " No drug-related adverse events were reported." | 3.30 | A Multi-Center Evaluation of the Pharmacokinetics and Safety of Intravenous Ibuprofen in Infants 1-6 Months of Age. ( Berkenbosch, JW; Gibson, BHY; Glover, CD; Kaelin, B; Patel, NV; Taylor, MB; Zhong, J, 2023) |
| "Fever is the most common reason for children's visits to medical centers." | 3.11 | Comparing the effect of body wash with marshmallow plant and lukewarm water on reducing the temperature of febrile children: a randomized clinical trial. ( Delfan, B; Ebrahimzade, F; Ghasemi, F; Goodarzi, H; Seifosadat, SH; Taee, N; Valizadeh, F, 2022) |
| " Globally, the pharmacologic treatment of pain in pediatric patients is limited largely to nonopioid analgesics, and dosing must account for differences in age, weight, metabolism, and risk of adverse effects." | 3.01 | Common Selfcare Indications of Pain Medications in Children. ( Bell, J; Kachroo, P; Mossali, VM; Siddiqui, K; Zempsky, W, 2023) |
| "Pain, swelling, infection, trismus and temperature were recorded on days 3, 7 and 14 after surgery." | 2.75 | Antibiotic prophylaxis in third molar surgery: A randomized double-blind placebo-controlled clinical trial using split-mouth technique. ( Morkel, JA; Siddiqi, A; Zafar, S, 2010) |
| "Fever is a common symptom in children and one of the major concerns of parents of younger and preschool-age children." | 2.75 | Ketoprofen versus paracetamol (acetaminophen) or ibuprofen in the management of fever: results of two randomized, double-blind, double-dummy, parallel-group, repeated-dose, multicentre, phase III studies in children. ( Kokki, H; Kokki, M, 2010) |
| "Fever was measured with the aid of a tympanic thermometer (Braun Kronberg 6014) and followed for 4-6 hours." | 2.74 | Antipyretic effect of ketoprofen. ( Akgoz, S; Arisoy, ES; Aygun, D; Celebi, S; Citak Kurt, AN; Hacimustafaoglu, M; Karali, Y; Seringec, M, 2009) |
| "At physician-directed dosing (acetaminophen 15 mg/kg vs ibuprofen 10 mg/kg), no significant differences in antipyretic effects from 0‒6 h and between 0‒6, ‒12, ‒24, or ‒48 h, with single or multiple-doses, respectively, were observed." | 2.72 | Acetaminophen and ibuprofen in the treatment of pediatric fever: a narrative review. ( Paul, IM; Walson, PD, 2021) |
| "Diclofenac-K was superior to placebo (P < 0." | 2.71 | A multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled, parallel-group comparison of diclofenac-K and ibuprofen for the treatment of adults with influenza-like symptoms. ( Frank, WO; Gold, MS; Grebe, W; Ionescu, E; Liu, JM, 2003) |
| "During subsequent treatment of the fever episode, parents had to call the investigator at least once each day to notify the investigator in case of febrile seizure recurrence." | 2.69 | Randomized, controlled trial of ibuprofen syrup administered during febrile illnesses to prevent febrile seizure recurrences. ( Derksen-Lubsen, G; Habbema, JD; Moll, HA; Steyerberg, EW; van Stuijvenberg, M, 1998) |
| "To analyse the population pharmacokinetic-pharmacodynamic relationships of racemic ibuprofen administered in suspension or as effervescent granules with the aim of exploring the effect of formulation on the relevant pharmacodynamic parameters." | 2.69 | Pharmacokinetic-Pharmacodynamic Modelling of the antipyretic effect of two oral formulations of ibuprofen. ( Armenteros, S; Benítez, J; Calvo, R; Domínguez, R; Planelles, MV; Trocóniz, IF, 2000) |
| "3 patients in the colorectal cancer group demonstrated objective responses (1 complete remission (CR), 2 partial remission (PR))." | 2.68 | Phase II trial of intravenous endotoxin in patients with colorectal and non-small cell lung cancer. ( Braun, M; Engelhardt, R; Galanos, C; Mackensen, A; Mertelsmann, R; Otto, F; Schmid, P; Seiz, A; Wehr, U, 1996) |
| " The statistical analysis of the results confirmed that ibuprofen and paracetamol are equivalent with respect to the following criteria (1) time elapsed between dosing and the lowest temperature: 3." | 2.68 | Equivalent antipyretic activity of ibuprofen and paracetamol in febrile children. ( d'Athis, P; Debregeas, S; Olive, G; Pariente-Khayat, A; Pons, G; Vauzelle-Kervroëdan, F, 1997) |
| " Pharmacokinetic and pharmacodynamic analyses were performed with temperature as the effect parameter and mean acetaminophen, total ibuprofen, and ibuprofen stereoisomer concentrations over time." | 2.67 | Pharmacokinetics and pharmacodynamics of ibuprofen isomers and acetaminophen in febrile children. ( Cox, S; Edge, JH; Kelley, MT; Mortensen, ME; Walson, PD, 1992) |
| "Ibuprofen liquid was given as a single dose, 5 mg/kg to 18 patients (group I) and 10 mg/kg to 18 patients (group II); placebo was administered to 20 patients (group III)." | 2.67 | Efficacy of ibuprofen in pediatric patients with fever. ( Durrell, DE; Gupta, N; Miller, MA; Nahata, MC; Powell, DA, 1992) |
| "Ibuprofen is a potent antipyretic agent and is a safe alternative for the selected febrile child who may benefit from antipyretic medication but who either cannot take or does not achieve satisfactory antipyresis with acetaminophen." | 2.67 | Antipyretic efficacy of ibuprofen vs acetaminophen. ( Kauffman, RE; Sawyer, LA; Scheinbaum, ML, 1992) |
| "Ibuprofen was evaluated as an antipyretic agent in 178 children (aged 3 months to 12 years) to compare dosage (5 vs 10 mg/kg), establish absolute efficacy (with a placebo control group), determine relative efficacy (ibuprofen vs acetaminophen), evaluate maximum efficacy, and identify potential confounding variables." | 2.67 | Single-dose, placebo-controlled comparative study of ibuprofen and acetaminophen antipyresis in children. ( Bertrand, KM; Brown, RD; Eichler, VF; Johnson, VA; Kearns, GL; Lowe, BA; Wilson, JT, 1991) |
| " Data suggesting that conditions associated with chronic liver damage reduce the dosing threshold for induction of liver failure are of particular concern." | 2.61 | Symptomatic treatment of dengue: should the NSAID contraindication be reconsidered? ( Fernandes, L; Kellstein, D, 2019) |
| "Ibuprofen (IBU) is an efficacious over-the-counter analgesic/antipyretic with adverse event (AE) rates comparable to placebo." | 2.52 | Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. ( Jayawardena, S; Kellstein, D; Leyva, R, 2015) |
| "Fever is a common symptom of childhood infections that in itself does not require treatment." | 2.50 | A practical approach to the treatment of low-risk childhood fever. ( Kanabar, D, 2014) |
| "The selected studies showed great heterogeneity of participants, temperature for fever diagnosis, interventions (dose and dosing intervals) and assessed outcomes." | 2.48 | Alternating antipyretics in the treatment of fever in children: a systematic review of randomized clinical trials. ( Dagostini, JM; Pereira, GL; Pizzol, Tda S, 2012) |
| "Ibuprofen, paracetamol and placebo have similar tolerability and safety profiles in terms of gastrointestinal symptoms, asthma and renal adverse effects." | 2.45 | Systematic review and meta-analysis of the clinical safety and tolerability of ibuprofen compared with paracetamol in paediatric pain and fever. ( Kleijnen, J; Soares-Weiser, K; Southey, ER, 2009) |
| " The evidence for modes of action of ibuprofen are considered in relation to its actions in controlling inflammation, pain and fever, as well as the adverse effects of the drug." | 2.45 | Ibuprofen: pharmacology, efficacy and safety. ( Rainsford, KD, 2009) |
| "Fever is the most common problem in medical situations, but controversy still surrounds its benefit/ risk ratio for human beings." | 2.44 | [Using evidence-based nursing to explore the management of child fever]. ( Huang, MC; Wang, YM, 2008) |
| " The review establishes that aspirin, paracetamol and ibuprofen are safe in OTC doses and that there is no evidence for any difference between the medicines as regards efficacy and safety for treatment of colds and flu (except in certain cases such as the use of aspirin in feverish children)." | 2.43 | Efficacy and safety of over-the-counter analgesics in the treatment of common cold and flu. ( Eccles, R, 2006) |
| "Fever is an important symptom of underlying disease condition and in general is considered harmful in pediatric age group as it may lead to febrile seizures, stupor, dehydration increase work of breathing, discomfort and tachycardia." | 2.41 | Antipyretics in children. ( Bhatnagar, SK; Chandra, J, 2002) |
| "Reasons for treating fever include patient discomfort, the potential for adverse sequelae, the possibility of seizures, and the possibility that fever could affect the pharmacokinetic profiles of drugs." | 2.38 | Antipyretic therapy in the febrile child. ( Drwal-Klein, LA; Phelps, SJ, 1992) |
| "The score was predictive of recurrence among most patient subgroups." | 1.62 | A risk score for pericarditis recurrence. ( Antonopoulos, AS; Imazio, M; Karavidas, A; Lazaros, G; Lazarou, E; Tousoulis, D; Toutouzas, K; Tsioufis, C; Vasileiou, P; Vassilopoulos, D; Vlachopoulos, C, 2021) |
| "Fever has been reported as a common symptom occurring in COVID-19 illness." | 1.56 | The use of ibuprofen to treat fever in COVID-19: A possible indirect association with worse outcome? ( Haryadi, TH; Jamerson, BD, 2020) |
| "Ibuprofen use was significantly lower in children diagnosed with wheezing (n = 22, 52." | 1.46 | Association of Acetaminophen and Ibuprofen Use With Wheezing in Children With Acute Febrile Illness. ( Elizur, A; Ganor, S; Kozer, E; Levine, H; Matok, I; Perlman, A, 2017) |
| "Acetaminophen was administered 2." | 1.46 | Parental Approach to the Prevention and Management of Fever and Pain Following Childhood Immunizations: A Survey Study. ( Moody, MA; Saleh, E; Swamy, GK; Walter, EB, 2017) |
| "Reactive arthritis is defined as arthritis that occurs during or after an extraarticular infection." | 1.43 | Hand-Foot and Mouth Dısease and Reactıve Arthritis: An Unusual Paediatric Case. ( A Esra, Y; C Nuket, Y; Neslihan, B; Sancar, E; Tugba, T, 2016) |
| " This study aimed to assess the health literacy skills of parents and caregivers of preschool-aged children, using a progressive scenario describing a child with fever and presenting tasks relating to selection of a medicine and hypothetical dosing of their child." | 1.40 | Management of children's fever by parents and caregivers: Practical measurement of functional health literacy. ( Chaw, XY; Emmerton, L; Kairuz, T; Kelly, F; Marriott, J; Moles, R; Wheeler, A, 2014) |
| "In Denmark, the traditional choice for treating fever and pain in children is paracetamol." | 1.38 | [Ibuprofen is more effective than paracetamol in lowering the temperature in febrile children]. ( Lundstrøm, KE, 2012) |
| "Ibuprofen is a well established analgesic, anti-inflammatory and antipyretic NSAID." | 1.38 | Intravenous ibuprofen: in adults for pain and fever. ( Scott, LJ, 2012) |
| "Fever is a common occurrence in the intensive care unit, and pharmacologic approaches are limited, particularly in patients unable to tolerate enteral medications." | 1.36 | Hot times in the intensive care unit. ( Abraham, E, 2010) |
| "Ibuprofen plasma concentration reached a Cmax of 74." | 1.36 | Ibuprofen transdermal ethosomal gel: characterization and efficiency in animal models. ( Ainbinder, D; Bercovich, R; Duchi, S; Shumilov, M; Touitou, E, 2010) |
| "We report a case of systemic onset juvenile idiopathic arthritis (SOJIA), the manifestations of which started with fever and skin rash followed by arthritis within neonatal age." | 1.35 | Systemic onset juvenile idiopathic arthritis--its unusual presentation. ( Chattopadhyay, N; Ghosh, JB; Gupta, D, 2008) |
| " Appropriate dosing and managing of these drugs do not likely lead to organ toxicity." | 1.35 | Acute non-oliguric kidney failure and cholestatic hepatitis induced by ibuprofen and acetaminophen: a case report. ( Angeli, S; Brugnara, M; Cuzzolin, L; Zaffanello, M, 2009) |
| "He had an upper respiratory tract infection in which a vaso-occlusive crisis was precipitated." | 1.34 | Tramadol infusion for the pain management in sickle cell disease: a case report. ( Aydinok, Y; Balkan, C; Erhan, E; Inal, MT; Yegul, I, 2007) |
| " There was a wide variability of the dosing interval." | 1.34 | Alternating antipyretics for fever reduction in children: an unfounded practice passed down to parents from pediatricians. ( Liebelt, EL; Wright, AD, 2007) |
| "This study used parental reports of the treatment of fever as an indicator of possible problems that may result from this policy, finding that the use of ineffective treatments and the overuse of drugs were common." | 1.34 | Treatment of fever and over-the-counter medicines. ( Purssell, E, 2007) |
| "However, bacterial infections are important causes of high fever in patients receiving myelosuppressive chemotherapy, and such fevers persist despite the use of COX inhibitors." | 1.33 | Endotoxin fever in granulocytopenic rats: evidence that brain cyclooxygenase-2 is more important than circulating prostaglandin E(2). ( Dascombe, MJ; Maldonado, R; Miñano, FJ; Tavares, E, 2006) |
| " We explore the toxicities of OTC cough and cold medications, discuss mechanisms of dosing errors, and suggest why physicians should be more vigilant in specifically inquiring about OTCs when evaluating an ill child." | 1.31 | Toxicity of over-the-counter cough and cold medications. ( Gunn, VL; Liebelt, EL; Serwint, JR; Taha, SH, 2001) |
| "6 hour-1, corresponding to a half-life of drug in the effect compartment of 1." | 1.28 | Effect of age on ibuprofen pharmacokinetics and antipyretic response. ( Kauffman, RE; Nelson, MV, 1992) |
| "For acetaminophen, the tlag was less than ibuprofen, Ka was more than ibuprofen, and beta was less than ibuprofen." | 1.28 | Single-dose pharmacokinetics of ibuprofen and acetaminophen in febrile children. ( Bertrand, KM; Brown, RD; Eichler, VF; Johnson, VA; Kearns, GL; Wilson, JT, 1992) |
| "We here present the case of a patient with severe neutropenia, haemolytic anaemia and thrombocytopenia associated with long-term use of ibuprofen." | 1.28 | A case of severe pancytopenia caused by ibuprofen. ( Lindblad, R; Rödjer, S, 1991) |
| "Fever is a part of the acute phase response, a generalized reaction to infection or inflammation initiated by interleukin-1 (IL-1)." | 1.27 | Fever. What to do and what not to do. ( Rosenthal, TC; Silverstein, DA, 1988) |
| "A 21-year-old woman with systemic lupus erythematosus (SLE) had meningismus, conjunctivitis, lymphadenopathy, and elevation of liver function values following ibuprofen therapy." | 1.26 | Tolmetin-induced aseptic meningitis. ( Barth, WF; Ruppert, GB, 1981) |
Research
Studies (285)
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 29 (10.18) | 18.7374 |
| 1990's | 58 (20.35) | 18.2507 |
| 2000's | 90 (31.58) | 29.6817 |
| 2010's | 82 (28.77) | 24.3611 |
| 2020's | 26 (9.12) | 2.80 |
Authors
| Authors | Studies |
|---|---|
| Terada, A | 1 |
| Naruto, S | 1 |
| Wachi, K | 1 |
| Tanaka, S | 1 |
| Iizuka, Y | 1 |
| Misaka, E | 1 |
| Kazama, I | 1 |
| Senzaki, M | 1 |
| Yin, F | 1 |
| Liu, Y | 1 |
| Guo, H | 1 |
| Tan, E | 2 |
| Hoare, K | 1 |
| Riley, J | 1 |
| Fernando, K | 1 |
| Haskell, L | 1 |
| McKinlay, CJ | 1 |
| Dalziel, SR | 2 |
| Braithwaite, I | 2 |
| Simon Junior, H | 1 |
| Pedreira, MC | 1 |
| Barbosa, SMM | 1 |
| Fernandes, TF | 1 |
| Escobar, AMU | 1 |
| Chilombe, MB | 1 |
| McDermott, MP | 1 |
| Seydel, KB | 1 |
| Mathews, M | 1 |
| Mwenechanya, M | 1 |
| Birbeck, GL | 1 |
| Goodarzi, H | 1 |
| Valizadeh, F | 1 |
| Ghasemi, F | 1 |
| Ebrahimzade, F | 1 |
| Seifosadat, SH | 1 |
| Delfan, B | 1 |
| Taee, N | 1 |
| Baker, AH | 2 |
| Monuteaux, MC | 2 |
| Michelson, KA | 2 |
| Neuman, MI | 2 |
| Zempsky, W | 1 |
| Bell, J | 1 |
| Mossali, VM | 1 |
| Kachroo, P | 1 |
| Siddiqui, K | 1 |
| Glover, CD | 1 |
| Berkenbosch, JW | 1 |
| Taylor, MB | 1 |
| Patel, NV | 1 |
| Kaelin, B | 1 |
| Gibson, BHY | 1 |
| Zhong, J | 1 |
| Zhou, P | 1 |
| Chen, L | 1 |
| Wang, E | 1 |
| He, L | 1 |
| Tian, S | 1 |
| Zhai, S | 1 |
| de Sévaux, JLH | 1 |
| Damoiseaux, RA | 2 |
| van de Pol, AC | 2 |
| Lutje, V | 1 |
| Hay, AD | 6 |
| Little, P | 2 |
| Schilder, AG | 2 |
| Venekamp, RP | 2 |
| Franceschi, F | 1 |
| Saviano, A | 1 |
| Carnicelli, A | 1 |
| Lorusso, C | 1 |
| Novelli, A | 1 |
| Candelli, M | 1 |
| Ojetti, V | 1 |
| Covino, M | 1 |
| Moffett, BS | 1 |
| Gutierrez, K | 1 |
| Davis, K | 1 |
| Sigdel, B | 1 |
| Strobel, N | 1 |
| Jamerson, BD | 1 |
| Haryadi, TH | 1 |
| Rinott, E | 1 |
| Kozer, E | 3 |
| Shapira, Y | 1 |
| Bar-Haim, A | 1 |
| Youngster, I | 3 |
| Joseph, L | 1 |
| Goldberg, S | 1 |
| Cohen, S | 1 |
| Picard, E | 1 |
| McKinlay, CJD | 1 |
| Alaje, EO | 1 |
| Udoh, EE | 1 |
| Akande, PA | 1 |
| Odey, FA | 1 |
| Meremikwu, MM | 1 |
| Gelernter, R | 1 |
| Ophir, N | 1 |
| Goldman, M | 1 |
| Lazarovitch, Z | 1 |
| Gamsu, S | 1 |
| Oren-Amit, A | 1 |
| Breitbart, R | 1 |
| Barkan Perl, S | 1 |
| Rosenberg, K | 1 |
| Can, Ö | 1 |
| Kıyan, GS | 1 |
| Yalçınlı, S | 1 |
| Long, B | 1 |
| Gottlieb, M | 1 |
| Alam, MM | 1 |
| Emon, NU | 1 |
| Alam, S | 1 |
| Rudra, S | 1 |
| Akhter, N | 1 |
| Mamun, MMR | 1 |
| Ganguly, A | 1 |
| Paul, IM | 3 |
| Walson, PD | 6 |
| Kloeden, B | 1 |
| Tham, D | 1 |
| Oakley, E | 1 |
| Cheek, J | 1 |
| Lazarou, E | 1 |
| Lazaros, G | 1 |
| Antonopoulos, AS | 1 |
| Imazio, M | 1 |
| Vasileiou, P | 1 |
| Karavidas, A | 1 |
| Toutouzas, K | 1 |
| Vassilopoulos, D | 1 |
| Tsioufis, C | 1 |
| Tousoulis, D | 1 |
| Vlachopoulos, C | 1 |
| Eizenga, WE | 1 |
| Opstelten, W | 1 |
| Hoag, SD | 1 |
| Chung, K | 1 |
| Narayan, K | 1 |
| Cooper, S | 1 |
| Morphet, J | 1 |
| Innes, K | 1 |
| Ziesenitz, VC | 1 |
| Zutter, A | 1 |
| Erb, TO | 1 |
| van den Anker, JN | 3 |
| Luo, S | 1 |
| Ran, M | 1 |
| Luo, Q | 1 |
| Shu, M | 1 |
| Guo, Q | 1 |
| Zhu, Y | 1 |
| Xie, X | 1 |
| Zhang, C | 1 |
| Wan, C | 1 |
| Osman, WA | 1 |
| Labib, DA | 1 |
| Abdelhalim, MO | 1 |
| Elrokh, EM | 1 |
| de Martino, M | 4 |
| Chiarugi, A | 1 |
| Boner, A | 1 |
| Montini, G | 1 |
| De' Angelis, GL | 1 |
| Rakowsky, S | 1 |
| Spiller, HA | 1 |
| Casavant, MJ | 1 |
| Chounthirath, T | 1 |
| Hodges, NL | 1 |
| Kim, EH | 1 |
| Smith, GA | 1 |
| Choi, SJ | 1 |
| Moon, S | 1 |
| Choi, UY | 1 |
| Chun, YH | 1 |
| Lee, JH | 1 |
| Rhim, JW | 1 |
| Lee, J | 1 |
| Kim, HM | 1 |
| Jeong, DC | 2 |
| Heinzl, S | 1 |
| Pigazzani, F | 1 |
| Mackenzie, I | 1 |
| MacDonald, TM | 1 |
| Chaucer, B | 1 |
| Stone, A | 1 |
| Whelan, D | 1 |
| Demanes, A | 1 |
| Fischer, JL | 1 |
| Kellstein, D | 3 |
| Fernandes, L | 1 |
| Islam, MT | 1 |
| Pires, SAP | 1 |
| Lemos, AP | 1 |
| Pereira, EPMN | 1 |
| Maia, PADSV | 1 |
| Agro, JPSEABD | 1 |
| Jia, LL | 1 |
| Li, R | 1 |
| Ma, J | 1 |
| Fan, Y | 1 |
| Li, HB | 1 |
| Malya, RR | 1 |
| Kim, CK | 1 |
| Callaway, Z | 1 |
| Choung, JT | 1 |
| Yu, JH | 1 |
| Shim, KS | 1 |
| Kwon, EM | 1 |
| Koh, YY | 2 |
| Emmerton, L | 1 |
| Chaw, XY | 1 |
| Kelly, F | 1 |
| Kairuz, T | 1 |
| Marriott, J | 1 |
| Wheeler, A | 1 |
| Moles, R | 1 |
| Wong, T | 3 |
| Stang, AS | 3 |
| Ganshorn, H | 3 |
| Hartling, L | 3 |
| Maconochie, IK | 3 |
| Thomsen, AM | 3 |
| Johnson, DW | 3 |
| Dvorkin, R | 1 |
| Bair, J | 1 |
| Patel, H | 1 |
| Glantz, S | 1 |
| Yens, DP | 1 |
| Rosalia, A | 1 |
| Marguilies, J | 1 |
| Chiappini, E | 3 |
| D'Elios, S | 1 |
| Mazzantini, R | 1 |
| Becherucci, P | 3 |
| Pierattelli, M | 1 |
| Galli, L | 3 |
| Pauchard, JY | 1 |
| Gehri, M | 1 |
| Kanabar, D | 2 |
| Jayawardena, S | 2 |
| Leyva, R | 1 |
| Bergese, SD | 1 |
| Candiotti, K | 1 |
| Ayad, SS | 1 |
| Soghomonyan, S | 1 |
| Gan, TJ | 1 |
| Watanabe, T | 1 |
| Abe, M | 1 |
| Tada, F | 1 |
| Aritomo, K | 1 |
| Ochi, H | 1 |
| Koizumi, Y | 1 |
| Tokumoto, Y | 1 |
| Hirooka, M | 1 |
| Kumagi, T | 1 |
| Ikeda, Y | 1 |
| Matsuura, B | 1 |
| Hiasa, Y | 1 |
| Sheehan, WJ | 2 |
| Mauger, DT | 1 |
| Moy, JN | 1 |
| Boehmer, SJ | 1 |
| Szefler, SJ | 1 |
| Fitzpatrick, AM | 1 |
| Jackson, DJ | 1 |
| Bacharier, LB | 1 |
| Cabana, MD | 1 |
| Covar, R | 1 |
| Holguin, F | 1 |
| Lemanske, RF | 1 |
| Martinez, FD | 1 |
| Pongracic, JA | 1 |
| Beigelman, A | 1 |
| Baxi, SN | 1 |
| Benson, M | 1 |
| Blake, K | 1 |
| Chmiel, JF | 1 |
| Daines, CL | 1 |
| Daines, MO | 1 |
| Gaffin, JM | 1 |
| Gentile, DA | 1 |
| Gower, WA | 1 |
| Israel, E | 1 |
| Kumar, HV | 1 |
| Lang, JE | 1 |
| Lazarus, SC | 1 |
| Lima, JJ | 1 |
| Ly, N | 1 |
| Marbin, J | 1 |
| Morgan, WJ | 1 |
| Myers, RE | 1 |
| Olin, JT | 1 |
| Peters, SP | 1 |
| Raissy, HH | 1 |
| Robison, RG | 1 |
| Ross, K | 1 |
| Sorkness, CA | 1 |
| Thyne, SM | 1 |
| Wechsler, ME | 1 |
| Phipatanakul, W | 2 |
| Mayor, S | 1 |
| Falup-Pecurariu, O | 1 |
| Man, SC | 1 |
| Neamtu, ML | 1 |
| Chicin, G | 1 |
| Baciu, G | 1 |
| Pitic, C | 1 |
| Cara, AC | 1 |
| Neculau, AE | 1 |
| Burlea, M | 1 |
| Brinza, IL | 1 |
| Schnell, CN | 1 |
| Sas, V | 1 |
| Lupu, VV | 1 |
| François, N | 1 |
| Swinnen, K | 1 |
| Borys, D | 1 |
| Koca, T | 1 |
| Akcam, M | 1 |
| Tugba, T | 1 |
| Neslihan, B | 1 |
| A Esra, Y | 1 |
| C Nuket, Y | 1 |
| Sancar, E | 1 |
| Lava, SA | 1 |
| Santi, M | 1 |
| Milani, GP | 1 |
| Bianchetti, MG | 1 |
| Simonetti, GD | 1 |
| Matok, I | 1 |
| Elizur, A | 1 |
| Perlman, A | 1 |
| Ganor, S | 1 |
| Levine, H | 1 |
| Saleh, E | 1 |
| Swamy, GK | 1 |
| Moody, MA | 1 |
| Walter, EB | 1 |
| Uzoigwe, CE | 1 |
| Ali, OH | 1 |
| Sjoukes, A | 1 |
| Kanabar, DJ | 1 |
| Khalil, SN | 1 |
| Hahn, BJ | 1 |
| Chumpitazi, CE | 1 |
| Rock, AD | 1 |
| Kaelin, BA | 1 |
| Macias, CG | 1 |
| Wysocki, J | 1 |
| Center, KJ | 1 |
| Brzostek, J | 1 |
| Majda-Stanislawska, E | 1 |
| Szymanski, H | 1 |
| Szenborn, L | 1 |
| Czajka, H | 1 |
| Hasiec, B | 1 |
| Dziduch, J | 1 |
| Jackowska, T | 1 |
| Witor, A | 1 |
| Kopińska, E | 1 |
| Konior, R | 1 |
| Giardina, PC | 1 |
| Sundaraiyer, V | 1 |
| Patterson, S | 1 |
| Gruber, WC | 1 |
| Scott, DA | 1 |
| Gurtman, A | 1 |
| Ghosh, JB | 1 |
| Gupta, D | 1 |
| Chattopadhyay, N | 1 |
| Kramer, LC | 1 |
| Richards, PA | 1 |
| Thompson, AM | 1 |
| Harper, DP | 1 |
| Fairchok, MP | 1 |
| Costelloe, C | 3 |
| Redmond, NM | 2 |
| Montgomery, AA | 2 |
| Fletcher, M | 4 |
| Hollinghurst, S | 3 |
| Peters, TJ | 3 |
| Harnden, A | 1 |
| Redmond, N | 2 |
| Montgomery, A | 1 |
| Purssell, E | 5 |
| Ospina, CA | 1 |
| Salcedo, A | 1 |
| Moore, ND | 1 |
| Tsuji, T | 1 |
| Asanuma, M | 1 |
| Miyazaki, I | 1 |
| Miyoshi, K | 1 |
| Ogawa, N | 1 |
| Yoon, JS | 1 |
| Oh, JW | 1 |
| Lee, KY | 1 |
| Lee, HS | 1 |
| Kim, JT | 1 |
| Kang, JH | 1 |
| Lee, JS | 1 |
| Guo, SX | 1 |
| Cheng, Y | 1 |
| Glatstein, M | 1 |
| Scolnik, D | 2 |
| Celebi, S | 1 |
| Hacimustafaoglu, M | 1 |
| Aygun, D | 1 |
| Arisoy, ES | 1 |
| Karali, Y | 1 |
| Akgoz, S | 1 |
| Citak Kurt, AN | 1 |
| Seringec, M | 1 |
| Zaffanello, M | 1 |
| Brugnara, M | 1 |
| Angeli, S | 1 |
| Cuzzolin, L | 1 |
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| Serwint, JR | 3 |
| Sabath, B | 1 |
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| Zhang, LG | 1 |
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| Kleijnen, J | 2 |
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| Rainsford, KD | 1 |
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Clinical Trials (31)
Trial Overview
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients: A Randomized Double-Blind Controlled Study[NCT06061575] | Phase 4 | 84 participants (Anticipated) | Interventional | 2023-10-31 | Not yet recruiting | ||
| Prospective Comparative Study of the Efficacy of Common Antipyretic Treatments in Febrile Children[NCT02294071] | Phase 4 | 120 participants (Anticipated) | Interventional | 2014-12-31 | Not yet recruiting | ||
| Hypoalgesic Effect of Median Nerve Neural Mobilization in Cervicobrachial Pain Compared to a Controlled Group[NCT02596815] | 51 participants (Actual) | Interventional | 2015-07-31 | Completed | |||
| Hypoalgesic Effect of Neural Mobilization in Cervicobrachial Pain Compared to a Controlled Group[NCT02595294] | 52 participants (Actual) | Interventional | 2015-07-31 | Completed | |||
| Hypoalgesic Effect of Median Nerve Neural Mobilization Versus Ibuprofen Pharmacologic Treatment in Patients With Cervicobrachial Pain[NCT02593721] | Phase 2/Phase 3 | 50 participants (Actual) | Interventional | 2015-07-31 | Completed | ||
| Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post-Surgical Dental Pain: Study I[NCT01098747] | Phase 3 | 335 participants (Actual) | Interventional | 2010-04-30 | Completed | ||
| Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Episodic Tension-Type Headache[NCT01077973] | Phase 3 | 200 participants (Actual) | Interventional | 2010-03-31 | Completed | ||
| Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post-Surgical Dental Pain[NCT01216163] | Phase 3 | 218 participants (Actual) | Interventional | 2010-10-31 | Completed | ||
| Ibuprofen Sodium Tension Headache Study[NCT01362491] | Phase 3 | 226 participants (Actual) | Interventional | 2011-06-30 | Completed | ||
| Evaluation Of The Antipyretic Efficacy Of Ibuprofen Sodium Tablets In Subjects With An Uncomplicated Acute Infection[NCT01035346] | Phase 3 | 16 participants (Actual) | Interventional | 2010-01-31 | Terminated | ||
| Acetaminophen vs. Ibuprofen in Children With Asthma[NCT01606319] | Phase 3 | 300 participants (Actual) | Interventional | 2013-02-28 | Completed | ||
| Impact of Immediate or Delayed Prophylactic Antipyretic Treatment on the Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline Biologicals' Pneumococcal Vaccine 1024850A and the Co-administered DTPa-combined Vaccines[NCT01235949] | Phase 4 | 850 participants (Actual) | Interventional | 2010-11-12 | Completed | ||
| A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients[NCT01002573] | Phase 3 | 118 participants (Actual) | Interventional | 2010-07-31 | Completed | ||
| A Phase 4, Randomized, Open-Label Trial To Assess The Impact Of Prophylactic Antipyretic Medication On The Immunogenicity Of 13-Valent Pneumococcal Conjugate Vaccine Given With Routine Pediatric Vaccinations In Healthy Infants[NCT01392378] | Phase 4 | 908 participants (Actual) | Interventional | 2011-08-31 | Completed | ||
| Postoperative Ibuprofen Use and Risk of Bleeding in Pediatric Tonsillectomy[NCT03385057] | Phase 1 | 0 participants (Actual) | Interventional | 2018-09-30 | Withdrawn (stopped due to Study design flaws; research design needed to be reconfigured) | ||
| Assessment of the Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic[NCT02268955] | 22 participants (Actual) | Interventional | 2014-09-09 | Completed | |||
| A Prospective, Randomized, Double-blind Study Assessing the Efficacy of Intravenous (IV) Ibuprofen Versus IV Acetaminophen for the Treatment of Pain Following Orthopaedic Low Extremity Surgery[NCT03771755] | 62 participants (Actual) | Interventional | 2017-07-01 | Completed | |||
| A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial To Evaluate The Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Adult Febrile Patients[NCT01131000] | Phase 3 | 123 participants (Actual) | Interventional | 2002-06-30 | Completed | ||
| Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever[NCT00267293] | Phase 4 | 60 participants (Actual) | Interventional | 2006-01-31 | Completed | ||
| Efficacy of Bromocriptine to Reduce Body Temperature in Febrile Critically-ill Adults With Acute Neurologic Disease: an Open-label, Blinded Endpoint, Randomized Controlled Trial[NCT03496545] | Phase 1/Phase 2 | 47 participants (Actual) | Interventional | 2018-11-30 | Completed | ||
| A Trial of Prednisone and Acetaminophen Versus Acetaminophen Alone in Minimizing Flu-like Symptoms From Pegylated Interferon Beta-1a[NCT03424733] | Phase 4 | 50 participants (Anticipated) | Interventional | 2017-09-25 | Recruiting | ||
| Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal[NCT05751837] | Phase 1 | 6 participants (Anticipated) | Interventional | 2023-03-16 | Recruiting | ||
| [NCT00000574] | Phase 3 | 0 participants | Interventional | 1990-09-30 | Completed | ||
| A Phase II Double Blind Randomized Controlled Trial of High Dose Vitamin B12 in Septic Shock[NCT03783091] | Phase 2 | 20 participants (Anticipated) | Interventional | 2019-08-05 | Recruiting | ||
| Control of Fever in Septic Patients[NCT04227652] | 140 participants (Actual) | Interventional | 2013-09-03 | Completed | |||
| Phase 2 Single Center, Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Evaluate Efficacy of Para-Tyrosine Supplementation on the Survival and Clinical Outcome in Patients With Sepsis[NCT03278730] | Phase 2 | 296 participants (Anticipated) | Interventional | 2025-02-28 | Not yet recruiting | ||
| Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy[NCT01605903] | Phase 2 | 741 participants (Actual) | Interventional | 2012-05-03 | Completed | ||
| Comparing Narcotics With Non-steroidal Anti-inflammatory Drugs (NSAIDS) Post-operatively in Pediatric Patients Undergoing Adenotonsillectomy[NCT02296840] | Phase 4 | 45 participants (Actual) | Interventional | 2014-11-30 | Terminated | ||
| Comparison of Supportive Therapies for Symptom Relief From Pediatric Upper Respiratory Infections (URIs)[NCT01814293] | 0 participants (Actual) | Interventional | 2013-05-31 | Withdrawn (stopped due to loss of funding. No data was collected.) | |||
| Evaluation of Postoperative Edema and Pain Following Third Molar Extraction With Application of Pulsed Electromagnetic Field (PEMF) Therapy[NCT02376946] | 49 participants (Actual) | Interventional | 2014-01-31 | Terminated (stopped due to Sponsor decision) | |||
| Efficacy of Steroids on Functional Outcomes After Musculoskeletal Injuries of the Hand[NCT05003596] | Phase 2/Phase 3 | 60 participants (Anticipated) | Interventional | 2021-09-01 | Not yet recruiting | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Trial Outcomes
Participant Global Evaluation of Study Medication
Participant global evaluation of study medication was performed at the 8-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent. (NCT01098747)
Timeframe: 8 hours
| Intervention | Units on a scale (Mean) |
|---|---|
| Placebo | 1.1 |
| Ibuprofen Sodium | 3.8 |
| Ibuprofen (Advil + Motrin IB) | 3.7 |
Time to Confirmed First Perceptible Relief
Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. (NCT01098747)
Timeframe: 0 to 8 hours
| Intervention | Minutes (Median) |
|---|---|
| Placebo | NA |
| Ibuprofen Sodium | 16.4 |
| Ibuprofen (Advil + Motrin IB) | 25.7 |
Time to Onset of Meaningful Relief
Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. (NCT01098747)
Timeframe: 0 to 8 hours
| Intervention | Minutes (Median) |
|---|---|
| Placebo | NA |
| Ibuprofen Sodium | 42.4 |
| Ibuprofen (Advil + Motrin IB) | 55.3 |
Time to Treatment Failure
Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication, whichever came first. (NCT01098747)
Timeframe: 0 to 8 hours
| Intervention | Hours (Median) |
|---|---|
| Placebo | 1.7 |
| Ibuprofen Sodium | NA |
| Ibuprofen (Advil + Motrin IB) | NA |
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8)
SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 8 hours. SPRID 0-8 score range: -8 (worst) to 56 (best). PRID: sum of Pain intensity differences (PID) and pain relief rating (PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). PID score range: -1(worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). (NCT01098747)
Timeframe: 0 to 8 hours
| Intervention | Units on a scale (Mean) |
|---|---|
| Placebo | 5.4 |
| Ibuprofen Sodium | 29.8 |
Cumulative Percentage of Participants With Complete Relief
Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. (NCT01098747)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
| Intervention | Percentage of participants (Number) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 0.25 hours | 0.5 hours | 1 hour | 1.5 hours | 2 hours | 3 hours | 4 hours | 5 hours | 6 hours | 7 hours | 8 hours | |
| Ibuprofen (Advil + Motrin IB) | 0.0 | 3.5 | 20.8 | 32.4 | 43.9 | 54.9 | 61.8 | 63.0 | 63.6 | 64.2 | 64.2 |
| Ibuprofen Sodium | 0.0 | 6.3 | 27.4 | 41.1 | 48.4 | 52.6 | 54.7 | 54.7 | 54.7 | 54.7 | 54.7 |
| Placebo | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 6.3 | 6.3 | 6.3 | 6.3 | 6.3 |
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
Percentage of participants with first perceptible relief was evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. (NCT01098747)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
| Intervention | Percentage of participants (Number) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 0.25 hours | 0.5 hours | 1 hour | 1.5 hours | 2 hours | 3 hours | 4 hours | 5 hours | 6 hours | 7 hours | 8 hours | |
| Ibuprofen (Advil + Motrin IB) | 12.1 | 60.7 | 84.4 | 87.3 | 87.9 | 88.4 | 88.4 | 88.4 | 88.4 | 88.4 | 88.4 |
| Ibuprofen Sodium | 26.3 | 84.2 | 94.7 | 95.8 | 95.8 | 95.8 | 95.8 | 95.8 | 95.8 | 95.8 | 95.8 |
| Placebo | 6.3 | 14.6 | 20.8 | 22.9 | 22.9 | 22.9 | 22.9 | 22.9 | 22.9 | 22.9 | 22.9 |
Cumulative Percentage of Participants With Meaningful Relief
Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered. (NCT01098747)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
| Intervention | Percentage of participants (Number) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 0.25 hours | 0.5 hours | 1 hour | 1.5 hours | 2 hours | 3 hours | 4 hours | 5 hours | 6 hours | 7 hours | 8 hours | |
| Ibuprofen (Advil + Motrin IB) | 0.6 | 16.8 | 52.6 | 69.9 | 79.8 | 86.7 | 87.9 | 87.9 | 87.9 | 87.9 | 88.4 |
| Ibuprofen Sodium | 1.1 | 28.4 | 73.7 | 87.4 | 91.6 | 94.7 | 94.7 | 94.7 | 94.7 | 95.8 | 95.8 |
| Placebo | 0.0 | 4.2 | 12.5 | 14.6 | 18.8 | 20.8 | 20.8 | 20.8 | 20.8 | 20.8 | 22.9 |
Cumulative Percentage of Participants With Treatment Failure
Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication. (NCT01098747)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
| Intervention | Percentage of participants (Number) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 0.25 hours | 0.5 hours | 1 hour | 1.5 hours | 2 hours | 3 hours | 4 hours | 5 hours | 6 hours | 7 hours | 8 hours | |
| Ibuprofen (Advil + Motrin IB) | 0.0 | 0.0 | 0.0 | 2.3 | 5.8 | 8.1 | 8.1 | 10.4 | 12.1 | 16.2 | 20.2 |
| Ibuprofen Sodium | 0.0 | 0.0 | 0.0 | 1.1 | 2.1 | 4.2 | 9.5 | 10.5 | 13.7 | 20.0 | 26.3 |
| Placebo | 0.0 | 0.0 | 0.0 | 25.0 | 54.2 | 70.8 | 70.8 | 70.8 | 72.9 | 77.1 | 79.2 |
Pain Intensity Difference (PID)
PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). (NCT01098747)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
| Intervention | Units on a scale (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 0.25 hours | 0.5 hours | 1 hour | 1.5 hour | 2 hours | 3 hours | 4 hours | 5 hours | 6 hours | 7 hours | 8 hours | |
| Ibuprofen (Advil + Motrin IB) | 0.1 | 0.6 | 1.3 | 1.5 | 1.7 | 1.7 | 1.7 | 1.6 | 1.5 | 1.2 | 1.1 |
| Ibuprofen Sodium | 0.3 | 1.0 | 1.5 | 1.7 | 1.8 | 1.6 | 1.5 | 1.4 | 1.2 | 0.9 | 0.8 |
| Placebo | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.1 | 0.0 | -0.0 | -0.0 | -0.0 |
Pain Relief Rating (PRR)
PRR was evaluated at different time points during the study up to 8 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. (NCT01098747)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
| Intervention | Units on a scale (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 0.25 hours | 0.5 hours | 1 hour | 1.5 hours | 2 hours | 3 hours | 4 hours | 5 hours | 6 hours | 7 hours | 8 hours | |
| Ibuprofen (Advil + Motrin IB) | 0.5 | 1.5 | 2.5 | 2.8 | 3.0 | 3.0 | 3.0 | 2.8 | 2.6 | 2.3 | 2.2 |
| Ibuprofen Sodium | 0.7 | 2.0 | 2.9 | 3.1 | 3.1 | 2.9 | 2.8 | 2.6 | 2.3 | 1.9 | 1.7 |
| Placebo | 0.4 | 0.5 | 0.6 | 0.7 | 0.7 | 0.7 | 0.8 | 0.7 | 0.7 | 0.5 | 0.5 |
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief). (NCT01098747)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
| Intervention | Units on a scale (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 0.25 hours | 0.5 hours | 1 hour | 1.5 hours | 2 hours | 3 hours | 4 hours | 5 hours | 6 hours | 7 hours | 8 hours | |
| Ibuprofen (Advil + Motrin IB) | 0.6 | 2.1 | 3.8 | 4.3 | 4.7 | 4.7 | 4.8 | 4.4 | 4.1 | 3.5 | 3.2 |
| Ibuprofen Sodium | 1.1 | 3.0 | 4.4 | 4.8 | 4.9 | 4.5 | 4.3 | 4.0 | 3.5 | 2.9 | 2.6 |
| Placebo | 0.4 | 0.6 | 0.7 | 0.7 | 0.8 | 0.7 | 0.9 | 0.8 | 0.6 | 0.5 | 0.5 |
Time-weighted Sum of Pain Intensity Difference (SPID)
SPID: time-weighted sum of PID over 2, 3, 6 and 8 hours. SPID scores range was -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, -6 (worst) to 18 (best) for SPID 0-6, -8 (worst) to 24 (best) for SPID 0-8. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3 (best). (NCT01098747)
Timeframe: 0-2, 0-3, 0-6, 0-8 hours
| Intervention | Units on a scale (Mean) | |||
|---|---|---|---|---|
| SPID 0-2 | SPID 0-3 | SPID 0-6 | SPID 0-8 | |
| Ibuprofen (Advil + Motrin IB) | 2.4 | 4.1 | 8.9 | 11.1 |
| Ibuprofen Sodium | 2.8 | 4.4 | 8.5 | 10.2 |
| Placebo | 0.1 | 0.1 | 0.2 | 0.1 |
Time-weighted Sum of Pain Relief Rating (TOTPAR)
TOTPAR: time-weighted sum of PRR scores over 2, 3, 6 and 8 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, 0 (worst) to 24 (best) for TOTPAR 0-6, 0 (worst) to 32 (best) for TOTPAR 0-8. PRR was evaluated at different time points during the study up to 8 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief. (NCT01098747)
Timeframe: 0-2, 0-3, 0-6, 0-8 hours
| Intervention | Units on a scale (Mean) | |||
|---|---|---|---|---|
| TOTPAR 0-2 | TOTPAR 0-3 | TOTPAR 0-6 | TOTPAR 0-8 | |
| Ibuprofen (Advil + Motrin IB) | 4.6 | 7.6 | 16.1 | 20.6 |
| Ibuprofen Sodium | 5.2 | 8.1 | 15.9 | 19.5 |
| Placebo | 1.3 | 2.0 | 4.2 | 5.2 |
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
SPRID: time-weighted sum of PRID over 2, 3, 6 and 8 hours. SPRID score range:-2 (worst) to 14(best) for SPRID 0-2, -3(worst) to 21(best) for SPRID 0-3, -6(worst) to 42(best) for SPRID 0-6, -8(worst) to 56(best) for SPRID 0-8. PRID:sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID:baseline pain severity score minus pain severity score at given time(score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: scored on 5-point pain relief rating scale(0=No relief to 4=Complete relief). (NCT01098747)
Timeframe: 0-2, 0-3, 0-6, 0-8 hours
| Intervention | Units on a scale (Mean) | |||
|---|---|---|---|---|
| SPRID 0-2 | SPRID 0-3 | SPRID 0-6 | SPRID 0-8 | |
| Ibuprofen (Advil + Motrin IB) | 7.0 | 11.8 | 25.0 | 31.7 |
| Ibuprofen Sodium | 8.0 | 12.6 | 24.3 | 29.8 |
| Placebo | 1.3 | 2.1 | 4.4 | 5.4 |
Time to Confirmed First Perceptible Relief
"Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful." (NCT01077973)
Timeframe: 0 to 3 hours
| Intervention | Minutes (Median) |
|---|---|
| Placebo | 42.3 |
| Ibuprofen Sodium | 41.7 |
| Ibuprofen (Motrin IB) | 43.8 |
Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet
"Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated meaningful relief at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered." (NCT01077973)
Timeframe: 0 to 3 hours
| Intervention | Minutes (Median) |
|---|---|
| Ibuprofen Sodium | 50.3 |
| Ibuprofen (Motrin IB) | 55.5 |
Time to Onset of Meaningful Relief: Remaining Comparisons
"Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated meaningful relief at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered." (NCT01077973)
Timeframe: 0 to 3 hours
| Intervention | Minutes (Median) |
|---|---|
| Placebo | 48.2 |
| Ibuprofen Sodium | 50.3 |
| Ibuprofen (Motrin IB) | 55.5 |
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet
SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). (NCT01077973)
Timeframe: 0 to 3 hours
| Intervention | Units on a scale (Mean) |
|---|---|
| Placebo | 11.2 |
| Ibuprofen Sodium | 10.8 |
Cumulative Percentage of Participants With Complete Relief
Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. (NCT01077973)
Timeframe: 1, 2, 3 hours
| Intervention | Percentage of participants (Number) | ||
|---|---|---|---|
| 1 hour | 2 hours | 3 hours | |
| Ibuprofen (Motrin IB) | 1.3 | 15.0 | 35.0 |
| Ibuprofen Sodium | 6.3 | 21.5 | 40.5 |
| Placebo | 2.4 | 17.1 | 41.5 |
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
"Percentage of participants with first perceptible relief evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful." (NCT01077973)
Timeframe: 0.5, 1, 2, 3 hours
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| 0.5 hours | 1 hour | 2 hours | 3 hours | |
| Ibuprofen (Motrin IB) | 28.8 | 72.5 | 82.5 | 82.5 |
| Ibuprofen Sodium | 30.4 | 67.1 | 81.0 | 81.0 |
| Placebo | 24.4 | 80.5 | 85.4 | 85.4 |
Cumulative Percentage of Participants With Meaningful Relief
"Percentage of participants with meaningful relief evaluated by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated meaningful relief at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered." (NCT01077973)
Timeframe: 0.5, 1, 2, 3 hours
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| 0.5 hours | 1 hour | 2 hours | 3 hours | |
| Ibuprofen (Motrin IB) | 10.0 | 60.0 | 81.3 | 82.5 |
| Ibuprofen Sodium | 17.7 | 58.2 | 79.7 | 81.0 |
| Placebo | 14.6 | 65.9 | 85.4 | 85.4 |
Pain Intensity Difference (PID)
PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). (NCT01077973)
Timeframe: 1, 2, 3 hours
| Intervention | Units on a scale (Mean) | ||
|---|---|---|---|
| 1 hour | 2 hours | 3 hours | |
| Ibuprofen (Motrin IB) | 0.8 | 1.2 | 1.4 |
| Ibuprofen Sodium | 0.9 | 1.3 | 1.5 |
| Placebo | 0.9 | 1.3 | 1.5 |
Pain Relief Rating (PRR)
PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief. (NCT01077973)
Timeframe: 1, 2, 3 hours
| Intervention | Units on a scale (Mean) | ||
|---|---|---|---|
| 1 hour | 2 hours | 3 hours | |
| Ibuprofen (Motrin IB) | 1.6 | 2.4 | 2.7 |
| Ibuprofen Sodium | 1.9 | 2.5 | 2.8 |
| Placebo | 1.9 | 2.6 | 3.0 |
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief). (NCT01077973)
Timeframe: 1, 2, 3 hours
| Intervention | Units on a scale (Mean) | ||
|---|---|---|---|
| 1 hour | 2 hours | 3 hours | |
| Ibuprofen (Motrin IB) | 2.4 | 3.6 | 4.1 |
| Ibuprofen Sodium | 2.8 | 3.7 | 4.3 |
| Placebo | 2.8 | 3.9 | 4.5 |
Time-weighted Sum of Pain Intensity Difference (SPID)
SPID: time-weighted sum of PID over 2 and 3 hours. SPID score range was -2(worst) to 6 (best) for SPID 0-2 and -3 (worst) to 9 (best) for SPID 0-3. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). (NCT01077973)
Timeframe: 0 to 2, 0 to 3 hours
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| SPID 0-2 | SPID 0-3 | |
| Ibuprofen (Motrin IB) | 2.0 | 3.4 |
| Ibuprofen Sodium | 2.2 | 3.6 |
| Placebo | 2.2 | 3.8 |
Time-weighted Sum of Pain Relief Rating (TOTPAR)
TOTPAR: time-weighted sum of PRR over 2 and 3 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2 and 0 (worst) to 12 (best) for TOTPAR 0-3. PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief. (NCT01077973)
Timeframe: 0 to 2, 0 to 3 hours
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| TOTPAR 0-2 | TOTPAR 0-3 | |
| Ibuprofen (Motrin IB) | 4.1 | 6.8 |
| Ibuprofen Sodium | 4.4 | 7.2 |
| Placebo | 4.5 | 7.5 |
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
SPRID: time-weighted sum of PRID over 2 and 3 hours. SPRID score range was -2(worst) to 14(best) for SPRID 0-2 and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). (NCT01077973)
Timeframe: 0 to 2, 0 to 3 hours
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| SPRID 0-2 | SPRID 0-3 | |
| Ibuprofen (Motrin IB) | 6.1 | 10.2 |
| Ibuprofen Sodium | 6.5 | 10.8 |
| Placebo | 6.7 | 11.2 |
Participant Global Evaluation of Study Medication
Participant global evaluation of study medication was performed at the 6-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent. (NCT01216163)
Timeframe: 6 hours
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 0.9 |
| Ibuprofen Sodium | 3.5 |
| Acetaminophen | 3.0 |
Time to Confirmed First Perceptible Relief
Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. (NCT01216163)
Timeframe: 0 to 6 hours
| Intervention | minutes (Median) |
|---|---|
| Placebo | NA |
| Ibuprofen Sodium | 16.0 |
| Acetaminophen | 23.7 |
Time to Onset of Meaningful Relief
Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. (NCT01216163)
Timeframe: 0 to 6 hours
| Intervention | minutes (Median) |
|---|---|
| Placebo | NA |
| Ibuprofen Sodium | 58.0 |
| Acetaminophen | 53.4 |
Time to Treatment Failure
Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first. (NCT01216163)
Timeframe: 0 to 6 hours
| Intervention | hours (Median) |
|---|---|
| Placebo | 1.6 |
| Ibuprofen Sodium | NA |
| Acetaminophen | NA |
Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6)
SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 6 hours. Score range: -6(worst) to 42(best) for SPRID 0-6. PRID: sum of pain intensity difference (PID) and pain relief rating (PRR) at each time point. Score range for PRID: -1(worst) to 7(best). PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). (NCT01216163)
Timeframe: 0 to 6 hours
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 2.8 |
| Ibuprofen Sodium | 20.0 |
| Acetaminophen | 17.1 |
Cumulative Percentage of Participants With Complete Relief
Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. (NCT01216163)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
| Intervention | percentage of participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 0.25 hours | 0.5 hours | 1 hours | 1.5 hours | 2 hours | 3 hours | 4 hours | 5 hours | 6 hours | |
| Acetaminophen | 1.2 | 4.7 | 15.3 | 24.7 | 29.4 | 32.9 | 35.3 | 35.3 | 35.3 |
| Ibuprofen Sodium | 0.0 | 6.8 | 23.9 | 29.5 | 36.4 | 42.0 | 45.5 | 45.5 | 46.6 |
| Placebo | 0.0 | 0.0 | 0.0 | 0.0 | 4.4 | 4.4 | 6.7 | 8.9 | 8.9 |
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
Percentage of participants with first perceptible relief evaluated by stopping the stopwatch labeled 'first perceptible relief' at the moment participant first began to experience any relief. First perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. (NCT01216163)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
| Intervention | percentage of participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 0.25 hours | 0.5 hours | 1 hour | 1.5 hours | 2 hours | 3 hours | 4 hours | 5 hours | 6 hours | |
| Acetaminophen | 24.7 | 62.4 | 72.9 | 74.1 | 74.1 | 74.1 | 74.1 | 74.1 | 74.1 |
| Ibuprofen Sodium | 28.4 | 64.8 | 78.4 | 79.5 | 79.5 | 79.5 | 79.5 | 79.5 | 79.5 |
| Placebo | 2.2 | 4.4 | 11.1 | 11.1 | 13.3 | 13.3 | 13.3 | 13.3 | 13.3 |
Cumulative Percentage of Participants With Meaningful Relief
Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled 'meaningful relief' at the moment participant first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. (NCT01216163)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
| Intervention | percentage of participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 0.25 hours | 0.5 hours | 1 hour | 1.5 hours | 2 hours | 3 hours | 4 hours | 5 hours | 6 hours | |
| Acetaminophen | 0.0 | 20.0 | 56.5 | 64.7 | 70.6 | 71.8 | 74.1 | 74.1 | 74.1 |
| Ibuprofen Sodium | 0.0 | 21.6 | 53.4 | 72.7 | 75.0 | 77.3 | 78.4 | 79.5 | 79.5 |
| Placebo | 0.0 | 0.0 | 0.0 | 2.2 | 8.9 | 11.1 | 13.3 | 13.3 | 13.3 |
Cumulative Percentage of Participants With Treatment Failure
Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication. (NCT01216163)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
| Intervention | percentage of participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 0.25 hours | 0.5 hours | 1 hour | 1.5 hours | 2 hours | 3 hours | 4 hours | 5 hours | 6 hours | |
| Acetaminophen | 0.0 | 0.0 | 0.0 | 2.4 | 12.9 | 21.2 | 27.1 | 32.9 | 35.3 |
| Ibuprofen Sodium | 0.0 | 0.0 | 0.0 | 2.3 | 5.7 | 11.4 | 15.9 | 25.0 | 29.5 |
| Placebo | 0.0 | 0.0 | 0.0 | 42.2 | 68.9 | 82.2 | 82.2 | 82.2 | 82.2 |
Pain Intensity Difference (PID)
PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). (NCT01216163)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
| Intervention | units on a scale (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 0.25 hours | 0.5 hours | 1 hour | 1.5 hours | 2 hours | 3 hours | 4 hours | 5 hours | 6 hours | |
| Acetaminophen | 0.2 | 0.5 | 1.0 | 1.1 | 1.1 | 0.9 | 0.9 | 0.8 | 0.6 |
| Ibuprofen Sodium | 0.3 | 0.8 | 1.3 | 1.3 | 1.3 | 1.2 | 1.1 | 0.9 | 0.9 |
| Placebo | -0.1 | -0.1 | 0.0 | -0.0 | -0.0 | -0.0 | -0.0 | 0.0 | -0.0 |
Pain Relief Rating (PRR)
PRR was evaluated at different time points during the study up to 6 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. (NCT01216163)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
| Intervention | units on a scale (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 0.25 hours | 0.5 hours | 1 hour | 1.5 hours | 2 hours | 3 hours | 4 hours | 5 hours | 6 hours | |
| Acetaminophen | 0.4 | 1.5 | 2.4 | 2.5 | 2.5 | 2.2 | 2.1 | 1.9 | 1.7 |
| Ibuprofen Sodium | 0.7 | 1.8 | 2.6 | 2.8 | 2.8 | 2.5 | 2.4 | 2.0 | 2.0 |
| Placebo | 0.1 | 0.3 | 0.6 | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 | 0.5 |
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief). (NCT01216163)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours
| Intervention | units on a scale (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 0.25 hours | 0.5 hours | 1 hour | 1.5 hours | 2 hours | 3 hours | 4 hours | 5 hours | 6 hours | |
| Acetaminophen | 0.6 | 2.0 | 3.4 | 3.7 | 3.6 | 3.1 | 3.0 | 2.7 | 2.3 |
| Ibuprofen Sodium | 0.9 | 2.5 | 3.9 | 4.1 | 4.1 | 3.7 | 3.6 | 2.9 | 2.8 |
| Placebo | 0.1 | 0.2 | 0.6 | 0.5 | 0.5 | 0.4 | 0.5 | 0.5 | 0.5 |
Time-weighted Sum of Pain Intensity Difference (SPID)
SPID: time-weighted sum of PID over 2, 3 and 6 hours. Total score range: -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, and -6 (worst) to 18 (best) for SPID 0-6. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). (NCT01216163)
Timeframe: 0 to 2, 0 to 3, 0 to 6 hours
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| SPID 0-2 | SPID 0-3 | SPID 0-6 | |
| Acetaminophen | 1.8 | 2.8 | 5.1 |
| Ibuprofen Sodium | 2.2 | 3.4 | 6.3 |
| Placebo | -0.1 | -0.1 | -0.1 |
Time-weighted Sum of Pain Relief Rating (TOTPAR)
TOTPAR: time-weighted sum of PRR over 2, 3, and 6 hours. Total score range: 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, and 0 (worst) to 24 (best) for TOTPAR 0-6. PRR was evaluated at different time points during the study up to 6 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. (NCT01216163)
Timeframe: 0 to 2, 0 to 3, 0 to 6 hours
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| TOTPAR 0-2 | TOTPAR 0-3 | TOTPAR 0-6 | |
| Acetaminophen | 4.2 | 6.4 | 12.0 |
| Ibuprofen Sodium | 4.7 | 7.2 | 13.6 |
| Placebo | 0.9 | 1.4 | 2.9 |
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
SPRID: time-weighted sum of PRID over 2 and 3 hours. Total score range: -2 (worst) to 14 (best) for SPRID 0-2, and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). (NCT01216163)
Timeframe: 0 to 2, 0 to 3 hours
| Intervention | units on a scale (Mean) | |
|---|---|---|
| SPRID 0-2 | SPRID 0-3 | |
| Acetaminophen | 6.0 | 9.1 |
| Ibuprofen Sodium | 6.9 | 10.6 |
| Placebo | 0.9 | 1.3 |
Cumulative Percentage of Participants With Treatment Failure
Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication. (NCT01362491)
Timeframe: 1, 2, 3 hours post-dose
| Intervention | percentage of participants (Number) |
|---|---|
| Ibuprofen Sodium | 0 |
| Ibuprofen (Motrin IB) | 0 |
| Placebo | 0 |
Time to Confirmed First Perceptible Relief
"Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful." (NCT01362491)
Timeframe: 0 to 3 hours
| Intervention | minutes (Median) |
|---|---|
| Ibuprofen Sodium | 36.9 |
| Ibuprofen (Motrin IB) | 43.6 |
| Placebo | NA |
Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet
"Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated meaningful relief at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered." (NCT01362491)
Timeframe: 0 to 3 hours
| Intervention | minutes (Median) |
|---|---|
| Ibuprofen Sodium | 40.6 |
| Ibuprofen (Motrin IB) | 48.5 |
Time to Onset of Meaningful Relief: Remaining Comparisons
"Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated meaningful relief at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered." (NCT01362491)
Timeframe: 0 to 3 hours
| Intervention | minutes (Median) |
|---|---|
| Ibuprofen Sodium | 40.6 |
| Ibuprofen (Motrin IB) | 48.5 |
| Placebo | NA |
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet
SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). (NCT01362491)
Timeframe: 0-3 Hours
| Intervention | units on scale (Mean) |
|---|---|
| Ibuprofen Sodium | 9.6 |
| Placebo | 3.5 |
Cumulative Percentage of Participants With Complete Relief
Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief (NCT01362491)
Timeframe: 1, 2, & 3 hours post-dose
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| 1 hour | 2 hours | 3 hours | |
| Ibuprofen (Motrin IB) | 0 | 4.5 | 38.2 |
| Ibuprofen Sodium | 0 | 5.5 | 37.4 |
| Placebo | 0 | 2.2 | 8.7 |
Cumulative Percentage of Participants With First Perceptible Relief
"Percentage of participants with first perceptible relief evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful." (NCT01362491)
Timeframe: 0.5, 1, 2, 3 hours
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| 0.5 hours | 1 hour | 2 hours | 3 hours | |
| Ibuprofen (Motrin IB) | 7.9 | 74.2 | 86.5 | 86.5 |
| Ibuprofen Sodium | 18.7 | 76.9 | 85.7 | 85.7 |
| Placebo | 0 | 15.2 | 45.7 | 45.7 |
Cumulative Percentage of Participants With Meaningful Relief
"Percentage of participants with meaningful relief evaluated by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated meaningful relief at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered." (NCT01362491)
Timeframe: 0.5, 1, 2, 3 hours
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| 0.5 hours | 1 hour | 2 hours | 3 hours | |
| Ibuprofen (Motrin IB) | 4.5 | 65.2 | 86.5 | 86.5 |
| Ibuprofen Sodium | 12.1 | 71.4 | 85.7 | 85.7 |
| Placebo | 0 | 13 | 39.1 | 45.7 |
Pain Intensity Difference (PID)
PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). (NCT01362491)
Timeframe: 1, 2 & 3 hours post-dose
| Intervention | units on scale (Mean) | ||
|---|---|---|---|
| 1 hour | 2 hours | 3 hours | |
| Ibuprofen (Motrin IB) | 0.7 | 1.0 | 1.4 |
| Ibuprofen Sodium | 0.7 | 1.0 | 1.3 |
| Placebo | 0.2 | 0.4 | 0.5 |
Pain Relief Rating (PRR)
PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief. (NCT01362491)
Timeframe: 1, 2 & 3 hours post-dose
| Intervention | units on scale (Mean) | ||
|---|---|---|---|
| 1 hour | 2 hours | 3 hours | |
| Ibuprofen (Motrin IB) | 1.6 | 2.2 | 2.9 |
| Ibuprofen Sodium | 1.5 | 2.3 | 2.8 |
| Placebo | 0.3 | 1.0 | 1.2 |
Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief). (NCT01362491)
Timeframe: 1, 2 & 3 hours post-dose
| Intervention | units on scale (Mean) | ||
|---|---|---|---|
| 1 hour | 2 hours | 3 hours | |
| Ibuprofen (Motrin IB) | 2.2 | 3.2 | 4.3 |
| Ibuprofen Sodium | 2.3 | 3.2 | 4.1 |
| Placebo | 0.5 | 1.4 | 1.7 |
Time-weighted Sum of Pain Intensity Difference (SPID)
SPID: time-weighted sum of PID over 2 and 3 hours. SPID score range was -2(worst) to 6 (best) for SPID 0-2 and -3 (worst) to 9 (best) for SPID 0-3. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). (NCT01362491)
Timeframe: 0 to 2, 0 to 3 hours
| Intervention | units on scale (Mean) | |
|---|---|---|
| SPID 0-2 | SPID 0-3 | |
| Ibuprofen (Motrin IB) | 1.7 | 3.1 |
| Ibuprofen Sodium | 1.7 | 3.0 |
| Placebo | 0.5 | 1.0 |
Time-weighted Sum of Pain Relief Rating (TOTPAR)
TOTPAR: time-weighted sum of PRR over 2 and 3 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2 and 0 (worst) to 12 (best) for TOTPAR 0-3. PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief. (NCT01362491)
Timeframe: 0 to 2, 0 to 3 hours
| Intervention | units on scale (Mean) | |
|---|---|---|
| TOTPAR 0-2 | TOTPAR 0-3 | |
| Ibuprofen (Motrin IB) | 3.8 | 6.6 |
| Ibuprofen Sodium | 3.8 | 6.6 |
| Placebo | 1.3 | 2.5 |
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
SPRID: time-weighted sum of PRID over 2 and 3 hours. SPRID score range was -2(worst) to 14(best) for SPRID 0-2 and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). (NCT01362491)
Timeframe: 0 to 2, 0 to 3 hours
| Intervention | units on scale (Mean) | |
|---|---|---|
| SPRID 0-2 | SPRID 0-3 | |
| Ibuprofen (Motrin IB) | 5.5 | 9.8 |
| Ibuprofen Sodium | 5.5 | 9.6 |
| Placebo | 1.8 | 3.5 |
Global Assessment of Study Medication as an Antipyretic
Global assessment of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent. (NCT01035346)
Timeframe: 8 hours
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 1.8 |
| Ibuprofen Sodium | 2.5 |
Rating of Study Medication Relative to Usual Medication
Rating of study medication was performed at the 8-hours time point or immediately before taking rescue medication (if necessary). It was scored on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent. (NCT01035346)
Timeframe: 8 hours
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 1.5 |
| Ibuprofen Sodium | 2.4 |
Time to Treatment Failure
Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first. (NCT01035346)
Timeframe: 0 to 8 hours
| Intervention | hours (Median) |
|---|---|
| Placebo | NA |
| Ibuprofen Sodium | NA |
Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)
STEMPD 0-6 was defined as time-weighted sum of temperature differences over 6 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature. (NCT01035346)
Timeframe: 0 to 6 hours
| Intervention | Degrees Fahrenheit (Mean) |
|---|---|
| Placebo | 3.0 |
| Ibuprofen Sodium | 10.8 |
Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8
Change from baseline in temperature was calculated as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature. (NCT01035346)
Timeframe: Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours
| Intervention | Degrees Fahrenheit (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| 0.25 hours | 0.5 hours | 1 hour | 2 hours | 4 hours | 6 hours | 8 hours | |
| Ibuprofen Sodium | 0.4 | 0.7 | 1.2 | 1.9 | 2.0 | 2.1 | 1.3 |
| Placebo | 0.4 | 0.5 | 0.3 | 0.8 | 0.3 | 0.7 | 1.3 |
Cumulative Percentage of Participants With Treatment Failure
Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication. (NCT01035346)
Timeframe: 0.25, 0.5, 1, 2, 4, 6, 8 hours
| Intervention | percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| 0.25 hours | 0.5 hours | 1 hour | 2 hours | 4 hours | 6 hours | 8 hours | |
| Ibuprofen Sodium | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 11.1 |
| Placebo | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8)
STEMPD 0-4 and STEMPD 0-8 were defined as the time-weighted sum of temperature differences over 4 hours and 8 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature. (NCT01035346)
Timeframe: 0 to 4, 0 to 8 hours
| Intervention | Degrees Fahrenheit (Mean) | |
|---|---|---|
| STEMPD 0-4 | STEMPD 0-8 | |
| Ibuprofen Sodium | 6.7 | 13.4 |
| Placebo | 1.7 | 5.7 |
Asthma Control Days
proportion of study days on which asthma was controlled, measured by electronic diary (NCT01606319)
Timeframe: last 46 weeks of 48 week treatment period
| Intervention | proportion of days (Mean) |
|---|---|
| Acetaminophen | .86 |
| Ibuprofen | .87 |
Asthma Rescue Medication Use
average albuterol rescue use per week, measured by electronic diary (NCT01606319)
Timeframe: last 46 weeks of 48 week treatment period
| Intervention | inhalations per week (Mean) |
|---|---|
| Acetaminophen | 2.8 |
| Ibuprofen | 3 |
Exacerbation Frequency
the number of asthma exacerbations requiring systemic corticosteroids (NCT01606319)
Timeframe: last 46 weeks of 48 week treatment period
| Intervention | asthma exacerbations per 46 weeks (Mean) |
|---|---|
| Acetaminophen | 0.81 |
| Ibuprofen | .87 |
Health Care Utilization
frequency of unscheduled physician visits, emergency department visits or hospitalizations for asthma (NCT01606319)
Timeframe: last 46 weeks of 48 week treatment period
| Intervention | unscheduled health visits per 46 weeks (Mean) |
|---|---|
| Acetaminophen | .75 |
| Ibuprofen | .76 |
Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)
Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL. (NCT01235949)
Timeframe: One month after primary immunization (Month 3)
| Intervention | mIU/mL (Geometric Mean) |
|---|---|
| IIBU Group | 911.85 |
| DIBU Group | 1139.1 |
| NIBU Group | 1245.07 |
| IPARA Group | 934.65 |
| DPARA Group | 674.25 |
| NPARA Group | 1027.79 |
Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)
Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL. (NCT01235949)
Timeframe: One month after primary immunization (Month 3)
| Intervention | µg/mL (Geometric Mean) |
|---|---|
| IIBU Group | 3.994 |
| DIBU Group | 3.66 |
| NIBU Group | 4.51 |
| IPARA Group | 3.29 |
| DPARA Group | 4.23 |
| NPARA Group | 5.007 |
Antibody Concentrations Against Protein D (Anti-PD)
Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units (EL.U) per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. (NCT01235949)
Timeframe: One month after primary immunization (At Month 3)
| Intervention | EL.U/mL (Geometric Mean) |
|---|---|
| IIBU Group | 1461.3 |
| DIBU Group | 1353.1 |
| NIBU Group | 1557.7 |
| IPARA Group | 1109.6 |
| DPARA Group | 1348.6 |
| NPARA Group | 1667.9 |
Number of Subjects With Any Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity. (NCT01235949)
Timeframe: During the entire study period (Month 0 to 10)
| Intervention | Participants (Count of Participants) |
|---|---|
| IIBU Group | 4 |
| DIBU Group | 4 |
| NIBU Group | 2 |
| IPARA Group | 4 |
| DPARA Group | 1 |
| NPARA Group | 0 |
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. (NCT01235949)
Timeframe: Within 31-days (Day 0-30) following booster vaccination
| Intervention | Subjects (Number) |
|---|---|
| IIBU-IIBU Group | 6 |
| IIBU-DIBU Group | 6 |
| IIBU-NIBU Group | 2 |
| DIBU-IIBU Group | 3 |
| DIBU-DIBU Group | 3 |
| DIBU-NIBU Group | 4 |
| NIBU-IIBU Group | 6 |
| NIBU-DIBU Group | 6 |
| NIBU-NIBU Group | 3 |
| IPARA-NPARA Group | 4 |
| DPARA-IPARA Group | 0 |
| NPARA-IPARA Group | 2 |
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. (NCT01235949)
Timeframe: Within 31-days (Day 0-30) following each primary vaccination dose
| Intervention | Participants (Count of Participants) |
|---|---|
| IIBU Group | 28 |
| DIBU Group | 33 |
| NIBU Group | 35 |
| IPARA Group | 16 |
| DPARA Group | 4 |
| NPARA Group | 13 |
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Anti-pneumococcal serotype 6A and 19A antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL. (NCT01235949)
Timeframe: One month after primary immunization (At Month 3)
| Intervention | μg/mL (Geometric Mean) | |
|---|---|---|
| Anti-6A | Anti-19A | |
| DIBU Group | 0.18 | 0.2 |
| DPARA Group | 0.12 | 0.17 |
| IIBU Group | 0.17 | 0.23 |
| IPARA Group | 0.11 | 0.15 |
| NIBU Group | 0.15 | 0.16 |
| NPARA Group | 0.19 | 0.25 |
Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids
Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in IU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL. (NCT01235949)
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)
| Intervention | IU/mL (Geometric Mean) | |||
|---|---|---|---|---|
| Anti-D, M9 | Anti-D, M10 | Anti-T, M9 | Anti-T, M10 | |
| DIBU-DIBU Group | 0.581 | 5.831 | 0.868 | 7.269 |
| DIBU-IIBU Group | 0.55 | 5.926 | 0.681 | 7.092 |
| DIBU-NIBU Group | 0.628 | 6.486 | 0.692 | 6.522 |
| DPARA-IPARA Group | 0.546 | 6.477 | 0.698 | 7.431 |
| IIBU-DIBU Group | 0.593 | 5.257 | 0.735 | 6.887 |
| IIBU-IIBU Group | 0.736 | 7.492 | 0.838 | 8.03 |
| IIBU-NIBU Group | 0.616 | 7.57 | 0.66 | 7.283 |
| IPARA-NPARA Group | 0.665 | 7.238 | 0.666 | 6.491 |
| NIBU-DIBU Group | 0.627 | 7.226 | 0.883 | 10.8 |
| NIBU-IIBU Group | 0.714 | 7.059 | 0.843 | 7.095 |
| NIBU-NIBU Group | 0.656 | 8.206 | 0.858 | 9.045 |
| NPARA-IPARA Group | 0.642 | 6.749 | 0.9 | 7.423 |
Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids
Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL. (NCT01235949)
Timeframe: One month after primary immunization (Month 3)
| Intervention | IU/mL (Geometric Mean) | |
|---|---|---|
| Anti-D | Anti-T | |
| DIBU Group | 2.938 | 3.373 |
| DPARA Group | 2.891 | 3.058 |
| IIBU Group | 3.326 | 3.746 |
| IPARA Group | 3.062 | 2.943 |
| NIBU Group | 3.132 | 3.961 |
| NPARA Group | 3.457 | 3.762 |
Antibody Concentrations Against Hepatitis B Surface Antigen
Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL. (NCT01235949)
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)
| Intervention | mIU/mL (Geometric Mean) | |
|---|---|---|
| Anti-HBs, M9 | Anti-HBs, M10 | |
| DIBU-DIBU Group | 225.01 | 2492.42 |
| DIBU-IIBU Group | 136.53 | 1685.87 |
| DIBU-NIBU Group | 194.51 | 2107.75 |
| DPARA-IPARA Group | 199.57 | 2003.09 |
| IIBU-DIBU Group | 210.32 | 1898.54 |
| IIBU-IIBU Group | 197.46 | 1949.42 |
| IIBU-NIBU Group | 164.33 | 1970.6 |
| IPARA-NPARA Group | 128.12 | 2078.63 |
| NIBU-DIBU Group | 244.52 | 2579.59 |
| NIBU-IIBU Group | 226.1 | 1851.22 |
| NIBU-NIBU Group | 159.79 | 3244.33 |
| NPARA-IPARA Group | 209.27 | 2218.23 |
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL. (NCT01235949)
Timeframe: One month after primary immunization (Month 3)
| Intervention | EL.U/mL (Geometric Mean) | ||
|---|---|---|---|
| Anti-PT | Anti-FHA | Anti-PRN | |
| DIBU Group | 64.2 | 171.6 | 114.3 |
| DPARA Group | 63.1 | 196.5 | 106.2 |
| IIBU Group | 59.1 | 163.1 | 103.9 |
| IPARA Group | 60.4 | 171 | 97.1 |
| NIBU Group | 65 | 191.1 | 118.1 |
| NPARA Group | 61.5 | 168.9 | 114 |
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL. (NCT01235949)
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)
| Intervention | EL.U/mL (Geometric Mean) | |||||
|---|---|---|---|---|---|---|
| Anti-PT, M9 | Anti-PT, M10 | Anti-FHA, M9 | Anti-FHA, M10 | Anti-PRN, M9 | Anti-PRN, M10 | |
| DIBU-DIBU Group | 14.2 | 75.5 | 59.3 | 322.9 | 25.1 | 246.2 |
| DIBU-IIBU Group | 14.7 | 72.3 | 53.8 | 359.8 | 22.4 | 262.9 |
| DIBU-NIBU Group | 13.6 | 74.8 | 57.7 | 332.7 | 16 | 184.3 |
| DPARA-IPARA Group | 10.8 | 66.8 | 48.5 | 332.9 | 19.7 | 214.2 |
| IIBU-DIBU Group | 12.8 | 64.4 | 42.6 | 252.7 | 16 | 173.5 |
| IIBU-IIBU Group | 13.3 | 73.8 | 46.1 | 308.8 | 15.7 | 218.6 |
| IIBU-NIBU Group | 10.5 | 56.6 | 42.6 | 327.2 | 18.3 | 225.9 |
| IPARA-NPARA Group | 13 | 59.4 | 50.8 | 321 | 20.1 | 205.1 |
| NIBU-DIBU Group | 12 | 74.9 | 45.7 | 338.6 | 18.8 | 255.7 |
| NIBU-IIBU Group | 12.8 | 63.4 | 57.9 | 312.3 | 19.4 | 226.7 |
| NIBU-NIBU Group | 15.2 | 97.6 | 59.1 | 442.8 | 27.3 | 330.4 |
| NPARA-IPARA Group | 14.2 | 57 | 52.9 | 294.2 | 20.3 | 213.6 |
Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)
Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in µg/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL. (NCT01235949)
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)
| Intervention | µg/mL (Geometric Mean) | |
|---|---|---|
| Anti-PRP, M9 | Anti-PRP, M10 | |
| DIBU-DIBU Group | 0.847 | 18.987 |
| DIBU-IIBU Group | 0.824 | 20.28 |
| DIBU-NIBU Group | 0.763 | 17.544 |
| DPARA-IPARA Group | 0.651 | 21.602 |
| IIBU-DIBU Group | 0.684 | 17.484 |
| IIBU-IIBU Group | 0.878 | 21.964 |
| IIBU-NIBU Group | 0.678 | 21.277 |
| IPARA-NPARA Group | 0.696 | 16.682 |
| NIBU-DIBU Group | 0.72 | 33.45 |
| NIBU-IIBU Group | 0.798 | 20.659 |
| NIBU-NIBU Group | 1.013 | 22.083 |
| NPARA-IPARA Group | 0.953 | 23.277 |
Antibody Concentrations Against Protein D (Anti-PD)
Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U//mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 100 EL.U/mL. (NCT01235949)
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)
| Intervention | EL.U/mL (Geometric Mean) | |
|---|---|---|
| Anti-PD, M9 | Anti-PD M10 | |
| DIBU-DIBU Group | 590 | 1664.8 |
| DIBU-IIBU Group | 622.9 | 1888.7 |
| DIBU-NIBU Group | 502 | 1540.7 |
| DPARA-IPARA Group | 525.4 | 1517.3 |
| IIBU-DIBU Group | 660.4 | 1980.1 |
| IIBU-IIBU Group | 661.6 | 2069 |
| IIBU-NIBU Group | 588.3 | 1907.5 |
| IPARA-NPARA Group | 446.1 | 1482.7 |
| NIBU-DIBU Group | 555.1 | 1953.1 |
| NIBU-IIBU Group | 752.1 | 2319.7 |
| NIBU-NIBU Group | 777.2 | 2285.5 |
| NPARA-IPARA Group | 691.3 | 2082.5 |
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti- pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL. (NCT01235949)
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)
| Intervention | μg/mL (Geometric Mean) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Anti-1, M9 | Anti-1, M10 | Anti-4, M9 | Anti-4, M10 | Anti-5, M9 | Anti-5, M10 | Anti-6B, M9 | Anti-6B M10 | Anti-7F, M9 | Anti-7F M10 | Anti-9V, M9 | Anti-9V M10 | Anti-14, M9 | Anti-14 M10 | Anti-18C M9 | Anti-18C M10 | Anti-19F M9 | Anti-19F M10 | Anti-23F M9 | Anti-23F M10 | Anti-6A, M9 | Anti-6A M10 | Anti-19A M9 | Anti-19A M10 | |
| IIBU-NIBU Group | 0.27 | 2.39 | 0.55 | 3.22 | 0.76 | 4.11 | 0.54 | 2.43 | 0.89 | 4.2 | 0.83 | 3.94 | 1.06 | 5.16 | 0.96 | 7.78 | 1.72 | 6.91 | 0.41 | 2.59 | 0.25 | 1.14 | 0.22 | 1.05 |
| IPARA-NPARA Group | 0.31 | 1.76 | 0.52 | 3.27 | 0.59 | 2.62 | 0.43 | 1.74 | 0.84 | 3.89 | 0.74 | 3.11 | 1.18 | 4.72 | 0.91 | 6.18 | 1.56 | 5.94 | 0.47 | 2.5 | 0.19 | 0.81 | 0.21 | 0.74 |
| NIBU-DIBU Group | 0.38 | 3.04 | 0.73 | 4.08 | 0.84 | 3.92 | 0.58 | 2.32 | 1.31 | 5.55 | 0.92 | 3.88 | 1.93 | 6.56 | 1.39 | 11.29 | 1.7 | 7.26 | 0.69 | 3.17 | 0.28 | 0.99 | 0.2 | 0.93 |
| NIBU-IIBU Group | 0.44 | 2.84 | 0.72 | 4.04 | 0.83 | 4.21 | 0.56 | 2.16 | 1.07 | 5.43 | 1.09 | 4.07 | 1.6 | 6.03 | 1.12 | 7.15 | 1.25 | 5.24 | 0.61 | 3.12 | 0.26 | 1.03 | 0.15 | 0.67 |
| NIBU-NIBU Group | 0.43 | 2.84 | 0.62 | 4.07 | 0.96 | 4.48 | 0.67 | 2.51 | 1.11 | 4.93 | 1.09 | 4.05 | 1.95 | 6.3 | 1.23 | 8.68 | 1.9 | 7.34 | 0.58 | 3.33 | 0.34 | 1.4 | 0.28 | 0.97 |
| NPARA-IPARA Group | 0.45 | 2.84 | 0.84 | 4.28 | 0.85 | 4.33 | 0.61 | 2.29 | 0.97 | 4.52 | 0.97 | 3.9 | 1.86 | 5.62 | 1.31 | 8.17 | 1.72 | 6.66 | 0.52 | 3.15 | 0.24 | 0.98 | 0.24 | 1.11 |
| DIBU-DIBU Group | 0.42 | 2.44 | 0.72 | 3.63 | 0.76 | 3.33 | 0.62 | 2.18 | 1.1 | 4.36 | 1.03 | 3.16 | 1.7 | 5.08 | 1.1 | 7.16 | 1.54 | 5.27 | 0.5 | 2.16 | 0.32 | 1.09 | 0.2 | 0.66 |
| DIBU-IIBU Group | 0.38 | 2.69 | 0.63 | 4.05 | 0.78 | 3.42 | 0.55 | 2.13 | 1.08 | 4.96 | 1.03 | 3.47 | 1.31 | 4.54 | 1.08 | 8.23 | 1.58 | 5.35 | 0.55 | 2.93 | 0.26 | 0.89 | 0.24 | 0.75 |
| DIBU-NIBU Group | 0.34 | 1.87 | 0.64 | 3.41 | 0.7 | 3.37 | 0.6 | 1.52 | 1.09 | 3.93 | 0.93 | 3.07 | 1.73 | 4.61 | 1.03 | 7.1 | 1.38 | 5.57 | 0.65 | 2.74 | 0.32 | 0.74 | 0.24 | 0.95 |
| DPARA-IPARA Group | 0.3 | 2.14 | 0.6 | 3.31 | 0.72 | 3.58 | 0.43 | 1.84 | 0.98 | 4.63 | 0.93 | 3.49 | 1.53 | 5.52 | 1.14 | 8.66 | 1.51 | 5.54 | 0.43 | 2.53 | 0.22 | 0.87 | 0.19 | 0.63 |
| IIBU-DIBU Group | 0.36 | 2.23 | 0.63 | 3.65 | 0.83 | 3.9 | 0.44 | 1.97 | 0.96 | 4.2 | 0.83 | 3.3 | 1.74 | 5.62 | 1.03 | 8.06 | 1.66 | 6.64 | 0.64 | 3.08 | 0.18 | 0.86 | 0.23 | 1.1 |
| IIBU-IIBU Group | 0.41 | 2.87 | 0.71 | 4.09 | 0.98 | 4.5 | 0.63 | 2.75 | 1.33 | 5.75 | 1.07 | 4.46 | 1.76 | 6.02 | 1.13 | 9.35 | 1.94 | 6.9 | 0.65 | 3.72 | 0.31 | 1.36 | 0.28 | 1.11 |
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL. (NCT01235949)
Timeframe: One month after primary immunization (At Month 3)
| Intervention | µg/mL (Geometric Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Anti-1 | Anti-4 | Anti-5 | Anti-6B | Anti-7F | Anti-9V | Anti-14 | Anti-18C | Anti-19F | Anti-23F | |
| DIBU Group | 1.71 | 2.21 | 2.39 | 0.76 | 2.83 | 2.01 | 4.52 | 3.8 | 5.04 | 0.92 |
| DPARA Group | 1.38 | 1.95 | 2.36 | 0.42 | 2.45 | 1.82 | 4.12 | 4.08 | 5.2 | 0.74 |
| IIBU Group | 1.82 | 2.25 | 2.93 | 0.67 | 2.87 | 2.1 | 4.76 | 3.85 | 6.11 | 1.04 |
| IPARA Group | 1.32 | 1.57 | 1.95 | 0.49 | 2.18 | 1.67 | 3.44 | 3.08 | 4.95 | 0.77 |
| NIBU Group | 1.9 | 2.21 | 2.77 | 0.6 | 2.77 | 2.18 | 4.77 | 4.34 | 4.96 | 1.07 |
| NPARA Group | 1.95 | 2.59 | 3.05 | 0.72 | 2.95 | 2.4 | 5.17 | 4.96 | 6.98 | 1 |
Antibody Titers Against Poliovirus Type 1, 2 and 3
Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8. (NCT01235949)
Timeframe: One month after primary immunization (Month 3)
| Intervention | Titers (Geometric Mean) | ||
|---|---|---|---|
| Anti-Polio 1 | Anti-Polio 2 | Anti-Polio 3 | |
| DIBU Group | 252.5 | 327.4 | 351.3 |
| DPARA Group | 166 | 394.8 | 394.8 |
| IIBU Group | 283.4 | 362 | 423.2 |
| IPARA Group | 225.6 | 240.7 | 284 |
| NIBU Group | 337 | 378 | 624.1 |
| NPARA Group | 449.3 | 335.2 | 438.6 |
Antibody Titers Against Poliovirus Type 1, 2 and 3
Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8. (NCT01235949)
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)
| Intervention | Titers (Geometric Mean) | |||||
|---|---|---|---|---|---|---|
| Anti-Polio 1, M9 | Anti-Polio 1, M10 | Anti-Polio 2, M9 | Anti-Polio 2, M10 | Anti-Polio 3, M9 | Anti-Polio 3, M10 | |
| DIBU-DIBU Group | 45.4 | 388 | 41.7 | 512.5 | 45.3 | 588.1 |
| DIBU-IIBU Group | 145.7 | 1824.5 | 292.1 | 2151.9 | 205.4 | 3649.1 |
| DIBU-NIBU Group | 32.1 | 543.9 | 8 | 542.4 | 45.2 | 1152.5 |
| DPARA-IPARA Group | 128.3 | 1448.1 | 139.6 | 1625.4 | 108.1 | 1625.4 |
| IIBU-DIBU Group | 85.9 | 790.7 | 60.8 | 1217.7 | 86 | 1724.5 |
| IIBU-IIBU Group | 56 | 1378.2 | 120.8 | 1949 | 72 | 861 |
| IIBU-NIBU Group | 80.9 | 429.9 | 48.3 | 548.7 | 127.8 | 359.5 |
| IPARA-NPARA Group | 53.8 | 1290.1 | 29.7 | 2047.9 | 96.5 | 2195 |
| NIBU-DIBU Group | 53.7 | 4 | 119.6 | 434.1 | 139.6 | 724.1 |
| NIBU-IIBU Group | 67.1 | 1217.7 | 134.8 | 1217.7 | 70 | 558.3 |
| NIBU-NIBU Group | 141.2 | 1075.9 | 156.1 | 1393.4 | 128 | 2233.3 |
| NPARA-IPARA Group | 117.4 | 861.1 | 168.9 | 1116.6 | 69.7 | 2048 |
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off
Antibodies against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) have been assessed by 22F-inhibition enzyme-linked immunosorbent assay (ELISA). The cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.2 micrograms per milliliter (μg/mL). (NCT01235949)
Timeframe: One month after primary immunization (At Month 3)
| Intervention | Participants (Count of Participants) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Anti-1 | Anti-4 | Anti-5 | Anti-6B | Anti-7F | Anti-9V | Anti-14 | Anti-18C | Anti-19F | Anti-23F | |
| DIBU Group | 155 | 155 | 154 | 135 | 157 | 153 | 153 | 153 | 152 | 141 |
| DPARA Group | 50 | 51 | 50 | 37 | 55 | 50 | 50 | 50 | 50 | 43 |
| IIBU Group | 144 | 145 | 143 | 121 | 153 | 144 | 144 | 143 | 145 | 136 |
| IPARA Group | 52 | 53 | 53 | 42 | 55 | 53 | 53 | 52 | 53 | 47 |
| NIBU Group | 160 | 158 | 156 | 133 | 164 | 155 | 154 | 155 | 157 | 149 |
| NPARA Group | 55 | 56 | 54 | 48 | 56 | 53 | 53 | 54 | 54 | 50 |
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm). (NCT01235949)
Timeframe: Within the 4-day (Days 0-3) period following booster vaccination
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| Any Pain | Grade 3 Pain | Any Redness | Grade 3 Redness | Any Swelling | Grade 3 Swelling | |
| DIBU-DIBU Group | 16 | 1 | 15 | 1 | 6 | 1 |
| DIBU-IIBU Group | 22 | 2 | 23 | 0 | 16 | 0 |
| DIBU-NIBU Group | 25 | 2 | 22 | 0 | 11 | 0 |
| DPARA-IPARA Group | 24 | 4 | 23 | 0 | 12 | 0 |
| IIBU-DIBU Group | 22 | 3 | 25 | 1 | 16 | 0 |
| IIBU-IIBU Group | 25 | 0 | 27 | 0 | 16 | 0 |
| IIBU-NIBU Group | 15 | 0 | 17 | 0 | 9 | 0 |
| IPARA-NPARA Group | 23 | 4 | 23 | 0 | 17 | 0 |
| NIBU-DIBU Group | 32 | 1 | 25 | 5 | 18 | 2 |
| NIBU-IIBU Group | 28 | 4 | 23 | 3 | 16 | 0 |
| NIBU-NIBU Group | 28 | 4 | 23 | 0 | 15 | 0 |
| NPARA-IPARA Group | 24 | 1 | 23 | 2 | 16 | 0 |
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm). (NCT01235949)
Timeframe: Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any Pain, Dose 1 | Grade 3 Pain, Dose 1 | Any Redness, Dose 1 | Grade 3 Redness, Dose 1 | Any Swelling, Dose 1 | Grade 3 Swelling, Dose 1 | Any Pain, Dose 2 | Grade 3 Pain, Dose 2 | Any Redness, Dose 2 | Grade 3 Redness, Dose 2 | Any Swelling, Dose 2 | Grade 3 Swelling, Dose 2 | Any Pain, Dose 3 | Grade 3 Pain, Dose 3 | Any Redness, Dose 3 | Grade 3 Redness, Dose 3 | Any Swelling, Dose 3 | Grade 3 Swelling, Dose 3 | Any Pain, Across doses | Grade 3 Pain, Across doses | Any Redness, Across doses | Grade 3 Redness, Across doses | Any Swelling, Across doses | Grade 3 Swelling, Across doses | |
| DIBU Group | 48 | 2 | 52 | 0 | 22 | 0 | 49 | 2 | 59 | 0 | 33 | 0 | 48 | 3 | 63 | 0 | 32 | 0 | 76 | 7 | 89 | 0 | 51 | 0 |
| DPARA Group | 28 | 2 | 19 | 0 | 7 | 1 | 22 | 0 | 23 | 0 | 11 | 1 | 21 | 1 | 25 | 2 | 12 | 0 | 37 | 3 | 35 | 2 | 17 | 1 |
| IIBU Group | 44 | 3 | 74 | 1 | 29 | 1 | 60 | 1 | 73 | 1 | 31 | 1 | 50 | 2 | 70 | 2 | 36 | 1 | 92 | 5 | 108 | 4 | 61 | 3 |
| IPARA Group | 21 | 2 | 24 | 0 | 10 | 0 | 19 | 2 | 24 | 0 | 10 | 1 | 18 | 1 | 28 | 0 | 16 | 0 | 30 | 5 | 36 | 0 | 20 | 1 |
| NIBU Group | 78 | 8 | 77 | 1 | 28 | 0 | 67 | 6 | 72 | 0 | 31 | 0 | 52 | 4 | 56 | 0 | 30 | 0 | 107 | 15 | 105 | 1 | 57 | 0 |
| NPARA Group | 33 | 7 | 32 | 0 | 11 | 0 | 25 | 1 | 31 | 2 | 12 | 2 | 22 | 1 | 27 | 2 | 13 | 2 | 44 | 7 | 46 | 2 | 19 | 2 |
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms included drowsiness, irritability, loss of appetite and fever [rectally, greater than or equal to (≥) 38 degrees Celsius (°C)]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination. (NCT01235949)
Timeframe: Within the 4-day (Days 0-3) period following booster vaccination
| Intervention | Participants (Count of Participants) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any Drowsiness | Grade 3 Drowsiness | Related Drowsiness | Any Irritability | Grade 3 Irritability | Related Irritability | Any Loss of appetite | Grade 3 Loss of appetite | Related Loss of appetite | Any Fever | Grade 3 Fever | Related Fever | |
| DIBU-DIBU Group | 9 | 0 | 9 | 26 | 0 | 20 | 15 | 1 | 15 | 19 | 1 | 18 |
| DIBU-IIBU Group | 19 | 1 | 13 | 22 | 3 | 13 | 12 | 1 | 9 | 19 | 0 | 17 |
| DIBU-NIBU Group | 21 | 0 | 17 | 27 | 3 | 23 | 19 | 0 | 17 | 20 | 0 | 18 |
| DPARA-IPARA Group | 16 | 0 | 13 | 22 | 3 | 20 | 10 | 1 | 6 | 14 | 0 | 13 |
| IIBU-DIBU Group | 18 | 1 | 13 | 27 | 3 | 18 | 16 | 0 | 11 | 21 | 0 | 17 |
| IIBU-IIBU Group | 18 | 1 | 15 | 33 | 1 | 22 | 14 | 0 | 11 | 22 | 0 | 20 |
| IIBU-NIBU Group | 17 | 0 | 13 | 23 | 1 | 13 | 9 | 0 | 4 | 15 | 0 | 12 |
| IPARA-NPARA Group | 12 | 1 | 10 | 26 | 2 | 18 | 9 | 0 | 8 | 21 | 0 | 18 |
| NIBU-DIBU Group | 24 | 0 | 18 | 33 | 0 | 26 | 24 | 0 | 19 | 23 | 0 | 19 |
| NIBU-IIBU Group | 22 | 0 | 17 | 36 | 3 | 27 | 21 | 3 | 19 | 20 | 0 | 18 |
| NIBU-NIBU Group | 24 | 2 | 21 | 32 | 3 | 27 | 14 | 1 | 12 | 28 | 0 | 24 |
| NPARA-IPARA Group | 19 | 0 | 16 | 27 | 0 | 16 | 17 | 0 | 13 | 18 | 0 | 16 |
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms included drowsiness, irritability, loss of appetite and fever [rectally, greater than or equal to (≥) 38 degrees Celsius (°C)]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination. (NCT01235949)
Timeframe: Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any Drowsiness, Dose 1 | Grade 3 Drowsiness, Dose 1 | Related Drowsiness, Dose 1 | Any Irritability, Dose 1 | Grade 3 Irritability, Dose 1 | Related Irritability, Dose 1 | Any Loss appetite, Dose 1 | Grade 3 Loss appetite, Dose 1 | Related Loss appetite, Dose 1 | Any Fever, Dose 1 | Grade 3 Fever, Dose 1 | Related Fever, Dose 1 | Any Drowsiness, Dose 2 | Grade 3 Drowsiness, Dose 2 | Related Drowsiness, Dose 2 | Any Irritability, Dose 2 | Grade 3 Irritability, Dose 2 | Related Irritability, Dose 2 | Any Loss appetite, Dose 2 | Grade 3 Loss appetite, Dose 2 | Related Loss appetite, Dose 2 | Any Fever, Dose 2 | Grade 3 Fever, Dose 2 | Related Fever, Dose 2 | Any Drowsiness, Dose 3 | Grade 3 Drowsiness, Dose 3 | Related Drowsiness, Dose 3 | Any Irritability, Dose 3 | Grade 3 Irritability, Dose 3 | Related Irritability, Dose 3 | Any Loss appetite, Dose 3 | Grade 3 Loss appetite, Dose 3 | Related Loss appetite, Dose 3 | Any Fever, Dose 3 | Grade 3 Fever, Dose 3 | Related Fever, Dose 3 | Any Drowsiness, Across doses | Grade 3 Drowsiness, Across doses | Related Drowsiness, Across doses | Any Irritability, Across doses | Grade 3 Irritability, Across doses | Related Irritability, Across doses | Any Loss appetite, Across doses | Grade 3 Loss appetite, Across doses | Related Loss appetite, Across doses | Any Fever, Across doses | Grade 3 Fever, Across doses | Related Fever, Across doses | |
| DIBU Group | 78 | 3 | 47 | 83 | 3 | 49 | 54 | 0 | 35 | 73 | 0 | 56 | 66 | 0 | 41 | 88 | 5 | 58 | 55 | 0 | 41 | 55 | 0 | 49 | 50 | 0 | 35 | 68 | 5 | 48 | 41 | 1 | 30 | 31 | 0 | 27 | 111 | 3 | 72 | 121 | 12 | 82 | 98 | 1 | 68 | 101 | 0 | 84 |
| DPARA Group | 28 | 0 | 17 | 34 | 1 | 16 | 19 | 1 | 11 | 11 | 0 | 8 | 15 | 0 | 12 | 31 | 1 | 22 | 11 | 0 | 8 | 15 | 0 | 10 | 8 | 0 | 5 | 21 | 2 | 12 | 9 | 0 | 7 | 7 | 0 | 5 | 33 | 0 | 22 | 43 | 4 | 28 | 24 | 1 | 16 | 27 | 0 | 18 |
| IIBU Group | 71 | 3 | 42 | 91 | 4 | 61 | 51 | 0 | 32 | 81 | 0 | 58 | 64 | 2 | 40 | 79 | 3 | 56 | 52 | 0 | 37 | 76 | 0 | 61 | 62 | 1 | 40 | 74 | 3 | 48 | 42 | 0 | 26 | 46 | 0 | 38 | 115 | 6 | 77 | 120 | 10 | 86 | 84 | 0 | 56 | 121 | 0 | 90 |
| IPARA Group | 33 | 1 | 20 | 27 | 3 | 18 | 11 | 0 | 8 | 8 | 0 | 6 | 28 | 0 | 16 | 30 | 1 | 20 | 12 | 0 | 7 | 14 | 0 | 11 | 18 | 0 | 12 | 17 | 1 | 10 | 9 | 0 | 5 | 12 | 0 | 7 | 40 | 1 | 26 | 40 | 4 | 28 | 24 | 0 | 16 | 23 | 0 | 18 |
| NIBU Group | 101 | 3 | 65 | 109 | 6 | 76 | 71 | 0 | 43 | 85 | 0 | 68 | 63 | 2 | 43 | 89 | 5 | 64 | 47 | 1 | 28 | 69 | 0 | 55 | 45 | 0 | 30 | 77 | 2 | 57 | 42 | 3 | 26 | 42 | 0 | 35 | 123 | 4 | 87 | 138 | 12 | 104 | 100 | 3 | 64 | 122 | 0 | 101 |
| NPARA Group | 36 | 1 | 24 | 43 | 3 | 27 | 32 | 1 | 20 | 30 | 0 | 23 | 25 | 1 | 15 | 37 | 1 | 25 | 22 | 0 | 14 | 24 | 1 | 19 | 16 | 0 | 11 | 29 | 0 | 17 | 16 | 1 | 12 | 14 | 0 | 12 | 45 | 2 | 32 | 59 | 4 | 40 | 42 | 2 | 30 | 40 | 1 | 31 |
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
"OPA titers against pneumococcal serotypes (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. When the number of subjects in a group for a specific category equals (=) 1, the lower limit and upper limit of the confidence interval that can't be calculated, are filled in with the GMT value (due to system constraint). Placeholder value 99999.9 has been entered when value to be entered in the system was greater than (>) 1.0 E10." (NCT01235949)
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)
| Intervention | Titers (Geometric Mean) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OPSONO-1, M9 | OPSONO-1, M10 | OPSONO-4, M9 | OPSONO-4, M10 | OPSONO-5, M9 | OPSONO-5, M10 | OPSONO-6B, M9 | OPSONO-6B, M10 | OPSONO-7F, M9 | OPSONO-7F, M10 | OPSONO-9V, M9 | OPSONO-9V, M10 | OPSONO-14, M9 | OPSONO-14, M10 | OPSONO-18C, M9 | OPSONO-18C, M10 | OPSONO-19F, M9 | OPSONO-19F, M10 | OPSONO-23F, M9 | OPSONO-23F, M10 | OPSONO-6A, M9 | OPSONO-6A, M10 | OPSONO-19A, M9 | OPSONO-19A, M10 | |
| IPARA-NPARA Group | 6 | 120.6 | 25.9 | 548.3 | 5.7 | 42.2 | 127.7 | 431.5 | 1290.9 | 11414.1 | 567.4 | 856.6 | 98.3 | 557.5 | 6.5 | 149.9 | 11 | 163.3 | 89.4 | 297 | 46.7 | 154 | 4 | 44.3 |
| NIBU-DIBU Group | 40.2 | 546.2 | 52.4 | 1149.8 | 12.7 | 128.9 | 13.7 | 173.1 | 1152 | 3565.8 | 282.1 | 2919.8 | 255.9 | 935.3 | 9.4 | 707.9 | 24.2 | 273.9 | 30.5 | 3682.7 | 34.1 | 106.9 | 4 | 253 |
| NIBU-IIBU Group | 7.3 | 388.2 | 98.1 | 1953.4 | 7.6 | 99.5 | 16.4 | 237.6 | 2563 | 14362.4 | 1075.2 | 4218.9 | 295 | 1498.1 | 31.9 | 428.6 | 15 | 572.7 | 499.7 | 4249.1 | 23.3 | 98.1 | 4 | 125.7 |
| NIBU-NIBU Group | 10.7 | 627 | 15.2 | 1414.1 | 9.8 | 184.6 | 182.5 | 1047.8 | 1263.5 | 5829.1 | 1571.3 | 8601.7 | 382.6 | 3817 | 5.5 | 481.3 | 53.2 | 250.6 | 15.6 | 1464.1 | 58.3 | 120 | 4 | 12.8 |
| NPARA-IPARA Group | 15.7 | 887.6 | 161.8 | 854.4 | 22.2 | 149.7 | 239 | 376.5 | 1744.7 | 7567.3 | 738.7 | 1340.1 | 195.4 | 587.5 | 14 | 242.7 | 48.4 | 511 | 37.7 | 875.2 | 24.5 | 78.5 | 4 | 541.6 |
| IIBU-NIBU Group | 4 | 316.4 | 4 | 2213.4 | 8.2 | 241.7 | 84.3 | 769.1 | 1762.5 | 12162.6 | 649.4 | 4756.1 | 47.2 | 4426.6 | 4 | 2394.7 | 88.5 | 2575.2 | 22.2 | 2792.9 | 13.4 | 318.4 | 4 | 21.2 |
| DIBU-DIBU Group | 50.6 | 248 | 407.6 | 1037.5 | 17.5 | 114.1 | 289.4 | 553.1 | 5343.2 | 9941.8 | 1423.6 | 3772.9 | 791.7 | 2002 | 21.9 | 650.6 | 17.7 | 1040.7 | 134 | 2096.1 | 224.8 | 74.5 | 7.4 | 29.8 |
| DIBU-IIBU Group | 50.3 | 158 | 9 | 2096.7 | 19 | 79 | 13.3 | 694.2 | 1729.9 | 11741 | 1302.7 | 4190.8 | 737.1 | 1507.6 | 11.5 | 397.3 | 9.7 | 637.1 | 29.7 | 2977.7 | 239.5 | 581.1 | 4 | 28 |
| DIBU-NIBU Group | 9.9 | 344.4 | 74.2 | 1096.7 | 10.8 | 165.8 | 208.9 | 1021.6 | 3522.8 | 5744.5 | 1081.9 | 4970.9 | 539.2 | 1312.4 | 10.9 | 298.1 | 67.8 | 1575 | 396.6 | 3530.1 | 99 | 169.2 | 4 | 325.4 |
| DPARA-IPARA Group | 12.2 | 736.3 | 56.3 | 1885.9 | 7.4 | 125.3 | 105.6 | 904.3 | 2256.2 | 21670 | 480.9 | 7262.2 | 260.7 | 2288 | 19.1 | 888.9 | 42.3 | 1215.3 | 274.5 | 1436.2 | 84 | 159.1 | 9.1 | 416.5 |
| IIBU-DIBU Group | 4 | 296.3 | 80.2 | 865.8 | 9.2 | 93.3 | 237.2 | 606.2 | 1777.3 | 4591.4 | 1283.8 | 7041.7 | 255.1 | 671.4 | 7.2 | 207.3 | 32.1 | 330.5 | 132.4 | 2381.5 | 45.1 | 125.4 | 4 | 4 |
| IIBU-IIBU Group | 5.8 | 346.2 | 34 | 928.1 | 12.9 | 131.8 | 96.1 | 745.6 | 2076 | 16259.9 | 830 | 4969 | 149.2 | 1592.9 | 7.2 | 912.9 | 63 | 1112.9 | 27.9 | 581 | 39.8 | 183.7 | 4 | 363.7 |
Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
OPA titers against pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was an antibody titer ≥ 8. (NCT01235949)
Timeframe: One month after primary immunization (Month 3)
| Intervention | Titers (Geometric Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OPSONO-1 | OPSONO-4 | OPSONO-5 | OPSONO-6B | OPSONO-7F | OPSONO-9V | OPSONO-14 | OPSONO-18C | OPSONO-19F | OPSONO-23F | OPSONO-6A | OPSONO-19A | |
| DIBU Group | 67.9 | 1172.3 | 52.4 | 882.4 | 4977.9 | 4040.4 | 1219.7 | 167.6 | 514.8 | 1105.5 | 151.1 | 46.1 |
| DPARA Group | 94 | 1712.4 | 70.7 | 140.3 | 7306.4 | 3777.1 | 1780.5 | 382.7 | 254.2 | 723 | 34.2 | 39.7 |
| IIBU Group | 69.4 | 1311 | 86.6 | 723 | 8827.7 | 3429.2 | 1346.3 | 186.9 | 536.2 | 989.8 | 79 | 16.6 |
| IPARA Group | 23 | 684.8 | 38.7 | 739.9 | 8362.7 | 5520.1 | 591.5 | 91.6 | 501.1 | 1188.4 | 100.7 | 11.2 |
| NIBU Group | 75.9 | 1027.7 | 74.3 | 361.3 | 6444.8 | 2744.2 | 1417.9 | 135.9 | 267.9 | 1296 | 26.4 | 20.4 |
| NPARA Group | 64.4 | 777.2 | 80.8 | 237.1 | 6286.1 | 2273.2 | 1460.1 | 106 | 272.1 | 838.4 | 44.5 | 11.4 |
Change From Baseline in Temperature After the First 30 Minutes of Treatment
Change in temperature in patients receiving intravenous ibuprofen and acetaminophen (APAP) after the first 30 minutes of treatment. (NCT01002573)
Timeframe: 30 minutes following treatment
| Intervention | Celsius (Mean) |
|---|---|
| Ibuprofen | -0.5 |
| Acetaminophen | -0.3 |
Change From Baseline in Temperature After the First 60 Minutes of Treatment
Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 60 minutes of treatment. (NCT01002573)
Timeframe: 60 minutes following treatment
| Intervention | Celsius (Mean) |
|---|---|
| Ibuprofen | -0.9 |
| Acetaminophen | -0.5 |
Change From Baseline in Temperature After the First Four Hours of Treatment
Change in temperature during the first 4 hours of treatment by assessing the area under the change in temperature versus time curve during the first four hours of treatment (AUC0-4) (NCT01002573)
Timeframe: 0 to 4 hours post-dose
| Intervention | degree Celsius*Time (Mean) |
|---|---|
| Ibuprofen | -4.4 |
| Acetaminophen | -2.6 |
Change in Temperature
Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 4 hours of treatment. (NCT01002573)
Timeframe: 4 hours following treatment
| Intervention | Celsius (Mean) |
|---|---|
| Ibuprofen | -1.5 |
| Acetaminophen | -0.9 |
Fever Reduction
Treatment of fever as measured by the area under the change in temperature versus time curve during the first two hours of treatment (AUC0-2) (NCT01002573)
Timeframe: 0 to 2 hours post-dose
| Intervention | degree Celsius*Time (Mean) |
|---|---|
| Ibuprofen | -1.5 |
| Acetaminophen | -0.9 |
Time to Afebrility (in Hours)
Tme to afebrility (temperature less than 100.4 ºF [38 ºC]) in patients receiving intravenous ibuprofen and APAP. (NCT01002573)
Timeframe: 4 Hour post treatment
| Intervention | Hours (Mean) |
|---|---|
| Ibuprofen | 2.2 |
| Acetaminophen | 3.3 |
Number of Afebrile and Febrile Subject at 4 Hours Post-Dose
Number of Afebrile and Febrile Subject at 4 Hours Following Treatment (NCT01002573)
Timeframe: 4 Hours Post-Dose
| Intervention | participants (Number) | |
|---|---|---|
| Afebrile Subjects at 4 hours | Febrile at 4 Hours | |
| Acetaminophen | 40 | 11 |
| Ibuprofen | 43 | 3 |
Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series
Geometric LS mean concentrations (GMCs) and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody. (NCT01392378)
Timeframe: 1 month after the infant series
| Intervention | mcg/mL (Geometric Mean) |
|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 0.54 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 0.59 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 0.49 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 0.51 |
| 13vPnC + INFANRIX Hexa | 0.58 |
Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured in mcg/mL and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody. (NCT01392378)
Timeframe: 1 month after the toddler dose
| Intervention | mcg/mL (Geometric Mean) |
|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 9.65 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 9.35 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 8.25 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 7.84 |
| 13vPnC + INFANRIX Hexa | 8.96 |
Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series
Geometric LS mean concentration (GMCs) were measured in milli international units/mL (mIU/mL) and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody. (NCT01392378)
Timeframe: 1 month after the infant series
| Intervention | mIU/mL (Geometric Mean) |
|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 756.42 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 770.93 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 689.34 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 599.12 |
| 13vPnC + INFANRIX Hexa | 733.29 |
Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured in mIU/mL and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody. (NCT01392378)
Timeframe: 1 month after the toddler dose
| Intervention | mIU/mL (Geometric Mean) |
|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 4868.61 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 4148.04 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 4250.41 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 4263.28 |
| 13vPnC + INFANRIX Hexa | 3866.37 |
Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured in EU/mL and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies. (NCT01392378)
Timeframe: 1 month after the toddler dose
| Intervention | EU/mL (Geometric Mean) | ||
|---|---|---|---|
| Pertussis PT | Pertussis FHA | Pertussis PRN | |
| 13vPnC + INFANRIX Hexa | 74.01 | 117.01 | 172.80 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 73.38 | 108.11 | 158.71 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 76.93 | 117.87 | 156.98 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 73.72 | 123.56 | 160.96 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 77.43 | 115.55 | 158.28 |
Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series
Geometric LS mean concentration (GMCs) were measured in Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies. (NCT01392378)
Timeframe: 1 month after the infant series
| Intervention | EU/mL (Geometric Mean) | ||
|---|---|---|---|
| Pertussis PT | Pertussis FHA | Pertussis PRN | |
| 13vPnC + INFANRIX Hexa | 44.85 | 48.42 | 84.57 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 39.26 | 35.55 | 68.53 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 43.51 | 40.65 | 71.26 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 40.27 | 41.32 | 65.82 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 40.86 | 46.29 | 72.90 |
Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured in IU/mL and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies. (NCT01392378)
Timeframe: 1 month after the toddler dose
| Intervention | IU/mL (Geometric Mean) | |
|---|---|---|
| Tetanus | Diphtheria | |
| 13vPnC + INFANRIX Hexa | 2.66 | 1.90 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 2.29 | 1.87 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 2.50 | 1.94 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 2.60 | 1.69 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 2.54 | 1.64 |
Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series
Geometric LS mean concentration (GMCs) were measured in International Units/mL (IU/mL) and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies. (NCT01392378)
Timeframe: 1 month after the infant series
| Intervention | IU/mL (Geometric Mean) | |
|---|---|---|
| Tetanus | Diphtheria | |
| 13vPnC + INFANRIX Hexa | 0.82 | 0.65 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 0.60 | 0.65 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 0.70 | 0.68 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 0.69 | 0.61 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 0.73 | 0.62 |
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
Antibody geometric least squares (LS) mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) confidence interval (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively. (NCT01392378)
Timeframe: 1 month after the infant series
| Intervention | microgram per milliliter (mcg/mL) (Geometric Mean) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4 (n = 137, 155, 148, 146, 210) | 6B (n = 136, 155, 148, 146, 210) | 9V (n = 138, 155, 148, 147, 210) | 14 (n = 138, 155, 148, 147, 210) | 18C (n = 138, 155, 148, 147, 210) | 19F (n = 138, 155, 148, 147, 210) | 23F (n= 137, 155, 148, 146, 210) | 1 (n = 138, 155, 148, 147, 210) | 3 (n = 138, 155, 148, 147, 210) | 5 (n = 137, 155, 148, 146, 210) | 6A (n = 138, 155, 148, 146, 210) | 7F (n = 138, 155, 148, 146, 210) | 19A (n = 137, 155, 148, 146, 210) | |
| 13vPnC + INFANRIX Hexa | 2.02 | 0.81 | 1.31 | 5.38 | 1.54 | 1.99 | 1.04 | 1.25 | 0.88 | 0.81 | 1.10 | 2.15 | 3.02 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 2.07 | 0.90 | 1.40 | 5.26 | 1.75 | 2.04 | 1.07 | 1.29 | 0.84 | 0.90 | 1.22 | 2.28 | 3.14 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 1.99 | 0.91 | 1.45 | 4.73 | 1.73 | 2.30 | 1.19 | 1.50 | 0.83 | 0.98 | 1.25 | 2.22 | 3.39 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 1.48 | 0.56 | 1.17 | 4.75 | 1.25 | 1.59 | 0.73 | 1.02 | 0.57 | 0.63 | 0.85 | 1.83 | 2.53 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 1.64 | 0.68 | 1.13 | 4.45 | 1.47 | 1.78 | 0.85 | 1.12 | 0.71 | 0.79 | 0.97 | 1.94 | 2.70 |
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
Antibody geometric LS mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm respectively. (NCT01392378)
Timeframe: 1 month after the toddler dose
| Intervention | mcg/mL (Geometric Mean) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4 (n = 130, 144, 143, 139, 206) | 6B (n = 130, 144, 143, 139, 206) | 9V (n = 130, 144, 143, 139, 206) | 14 (n = 130, 144, 143, 139, 206) | 18C (n = 130, 144, 143, 139, 206) | 19F (n = 130, 144, 143, 139, 206) | 23F (n = 130, 144, 142, 139, 206) | 1 (n = 130, 144, 143, 139, 206) | 3 (n = 129, 144, 143, 138, 203) | 5 (n = 130, 144, 143, 139, 206) | 6A (n = 130, 144, 143, 139, 206) | 7F (n = 130, 144, 142, 139, 206) | 19A (n = 129, 144, 142, 139, 206) | |
| 13vPnC + INFANRIX Hexa | 3.10 | 7.08 | 2.16 | 9.10 | 1.59 | 7.95 | 2.75 | 3.04 | 0.54 | 2.84 | 5.52 | 3.98 | 7.71 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 3.43 | 7.30 | 2.12 | 9.12 | 1.63 | 8.02 | 2.86 | 3.12 | 0.49 | 2.62 | 5.36 | 3.97 | 7.35 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 3.43 | 8.01 | 2.23 | 8.40 | 1.68 | 8.99 | 2.96 | 3.22 | 0.54 | 2.75 | 5.73 | 3.89 | 7.99 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 2.97 | 6.38 | 2.17 | 7.95 | 1.36 | 7.53 | 2.37 | 2.66 | 0.46 | 2.40 | 5.27 | 3.56 | 7.31 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 3.07 | 6.70 | 2.15 | 8.10 | 1.35 | 8.41 | 2.34 | 2.80 | 0.46 | 2.33 | 5.12 | 3.79 | 7.11 |
Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series
Geometric LS mean concentrations (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies. (NCT01392378)
Timeframe: 1 month after the infant series
| Intervention | titer (Geometric Mean) | ||
|---|---|---|---|
| Poliomyelitis Type 1 | Poliomyelitis Type 2 | Poliomyelitis Type 3 | |
| 13vPnC + INFANRIX Hexa | 72.02 | 67.37 | 231.02 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 70.66 | 55.17 | 218.85 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 66.59 | 73.52 | 184.03 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 67.43 | 62.12 | 257.92 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 68.11 | 79.60 | 246.22 |
Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies. (NCT01392378)
Timeframe: 1 month after the toddler dose
| Intervention | titer (Geometric Mean) | ||
|---|---|---|---|
| Poliomyelitis Type 1 | Poliomyelitis Type 2 | Poliomyelitis Type 3 | |
| 13vPnC + INFANRIX Hexa | 406.37 | 621.07 | 1237.86 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 415.45 | 605.78 | 1187.11 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 426.63 | 586.30 | 1045.57 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 443.97 | 587.56 | 1210.29 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 399.56 | 613.18 | 1205.80 |
Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
Antibody-mediated serum OPA against the 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). (NCT01392378)
Timeframe: 1 month after the infant series
| Intervention | titer (Geometric Mean) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4 (n = 37, 46, 42, 41, 61) | 6B (n = 36, 45, 43, 40, 62) | 9V (n = 37, 48, 42, 41, 65) | 14 (n = 38, 48, 41, 41, 64) | 18C (n = 37, 47, 41, 41, 62) | 19F (n = 37, 46, 41, 42, 63) | 23F (n = 38, 45, 42, 42, 63) | 1 (n = 42, 42, 43, 44, 74) | 3 (n = 41, 41, 39, 39, 69) | 5 (n = 42, 43, 44, 42, 73) | 6A (n = 46, 42, 39, 39, 76) | 7F (n = 46, 42, 40, 39, 76) | 19A (n = 42, 44, 41, 42, 74) | |
| 13vPnC + INFANRIX Hexa | 1086 | 748 | 241 | 951 | 1092 | 279 | 366 | 12 | 87 | 76 | 1462 | 2125 | 240 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 1361 | 663 | 285 | 991 | 1031 | 294 | 321 | 8 | 62 | 99 | 1281 | 1584 | 159 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 1135 | 655 | 166 | 622 | 853 | 221 | 441 | 11 | 76 | 96 | 1681 | 1907 | 257 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 1240 | 470 | 93 | 650 | 877 | 165 | 332 | 8 | 56 | 54 | 1228 | 1747 | 163 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 1269 | 794 | 120 | 435 | 1094 | 346 | 342 | 12 | 72 | 86 | 1060 | 1766 | 185 |
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events after the infant series were events between 1 month (28 to 42 days) after infant series to toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs spontaneously collected on case report form (non-systematic assessment). (NCT01392378)
Timeframe: 1 Month (28 to 42 days) after infant series Dose 3 up to toddler dose
| Intervention | participants (Number) | |
|---|---|---|
| Non-SAEs | SAEs | |
| 13vPnC + INFANRIX Hexa | 8 | 9 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 4 | 11 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 6 | 14 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 3 | 10 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 3 | 6 |
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for infant series were events between infant series Dose 1 and up to 1 month (28 to 42 days) after infant series that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment). (NCT01392378)
Timeframe: Baseline up to 1 Month (28 to 42 days) after infant series
| Intervention | participants (Number) | |
|---|---|---|
| Non-SAEs | SAEs | |
| 13vPnC + INFANRIX Hexa | 80 | 10 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 72 | 8 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 71 | 3 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 67 | 11 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 57 | 7 |
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for toddler dose were events between toddler dose and up to 1 month (28 to 42 days) after toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment). (NCT01392378)
Timeframe: Toddler dose up to 1 Month (28 to 42 days) after toddler dose
| Intervention | participants (Number) | |
|---|---|---|
| Non-SAEs | SAEs | |
| 13vPnC + INFANRIX Hexa | 50 | 1 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 76 | 1 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 57 | 2 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 52 | 1 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 47 | 3 |
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series
Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.6 EU/mL, FHA >=16.1 EU/mL, PRN >=24.0 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group. (NCT01392378)
Timeframe: 1 month after the infant series
| Intervention | percentage of participants (Number) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Hib PRP >=0.15 mcg/mL (n= 136, 146, 144, 139, 198) | Hib PRP >=1 mcg/mL (n = 136, 146, 144, 139, 198) | Pertussis PT >=14.6 EU/mL (n= 132,143,141,131,193) | Pertussis FHA >=16.1 EU/mL (n=132,143,141,131,193) | Pertussis PRN >=24.0 EU/mL (n=132,143,141,131,193) | Tetanus >=0.1 IU/mL (n = 132,143,141,131,193) | Diphtheria >=0.1 IU/mL (n = 132,143,141,131,193) | HBV >= 10mIU/mL (n = 105,116,120,112,156) | PoliomyelitisType1 >=1:8titer (n=89,105,93,84,135) | PoliomyelitisType2 >=1:8titer (n=89,105,93,84,135) | PoliomyelitisType3 >=1:8titer (n=89,105,93,84,135) | |
| 13vPnC + INFANRIX Hexa | 87.9 | 33.8 | 95.3 | 95.3 | 95.3 | 99.5 | 99.5 | 98.7 | 99.3 | 95.6 | 99.3 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 85.6 | 28.1 | 90.8 | 88.5 | 89.3 | 98.5 | 97.7 | 99.1 | 100.0 | 96.4 | 98.8 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 84.2 | 37.0 | 97.2 | 92.3 | 87.4 | 100.0 | 98.6 | 99.1 | 98.1 | 98.1 | 100.0 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 86.1 | 27.1 | 91.5 | 93.6 | 88.7 | 100.0 | 99.3 | 99.2 | 97.8 | 95.7 | 98.9 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 87.5 | 33.8 | 93.2 | 96.2 | 90.9 | 100.0 | 100.0 | 100.0 | 97.8 | 95.5 | 100.0 |
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose
Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.8 EU/mL, FHA >=46.5 EU/mL, PRN >=43.5 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group. (NCT01392378)
Timeframe: 1 month after the toddler dose
| Intervention | percentage of participants (Number) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Hib PRP >=0.15 mcg/mL (n= 126, 135, 141, 138, 202) | Hib PRP >=1 mcg/mL (n = 126, 135, 141, 138, 202) | Pertussis PT >=14.8 EU/mL (n= 123,137,141,136,199) | Pertussis FHA >=46.5 EU/mL (n=123,137,141,136,199) | Pertussis PRN >=43.5 EU/mL (n=123,137,141,136,199) | Tetanus >=0.1 IU/mL (n = 123,137,141,136,199) | Diphtheria >=0.1 IU/mL (n = 123,137,141,136,199) | HBV >= 10 mIU/mL (n = 119,131,133,133,191) | Poliomyelitis 1 >=1:8titer (n=123,133,141,136,201) | Poliomyelitis 2 >=1:8titer (n=123,133,141,136,201) | Poliomyelitis 3 >=1:8titer (n=123,133,141,136,201) | |
| 13vPnC + INFANRIX Hexa | 100.0 | 95.0 | 95.5 | 95.5 | 95.5 | 100.0 | 100.0 | 99.5 | 99.5 | 100.0 | 100.0 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 100.0 | 95.7 | 100.0 | 92.6 | 94.1 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 99.3 | 96.3 | 99.3 | 94.9 | 94.9 | 100.0 | 100.0 | 98.5 | 100.0 | 100.0 | 100.0 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 100.0 | 95.7 | 98.6 | 93.6 | 94.3 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 100.0 | 95.2 | 97.6 | 91.1 | 91.9 | 100.0 | 100.0 | 100.0 | 99.2 | 100.0 | 100.0 |
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. (NCT01392378)
Timeframe: 1 month after the infant series
| Intervention | percentage of participants (Number) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4 (n = 137, 155, 148, 146, 210) | 6B (n = 136, 155, 148, 146, 210) | 9V (n = 138, 155, 148, 147, 210) | 14 (n = 138, 155, 148, 147, 210) | 18C (n = 138, 155, 148, 147, 210) | 19F (n = 138, 155, 148, 147, 210) | 23F (n = 137, 155, 148, 146, 210) | 1 (n = 138, 155, 148, 147, 210) | 3 (n = 138, 155, 148, 147, 210) | 5 (n = 137, 155, 148, 146, 210) | 6A (n = 138, 155, 148, 146, 210) | 7F (n = 138, 155, 148, 146, 210) | 19A (n = 137, 155, 148, 146, 210) | |
| 13vPnC + INFANRIX Hexa | 98.1 | 77.6 | 96.2 | 99.5 | 96.7 | 97.6 | 88.1 | 94.3 | 91.0 | 84.3 | 91.9 | 99.5 | 100.0 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 97.3 | 79.5 | 95.9 | 98.6 | 95.9 | 96.6 | 88.4 | 94.6 | 88.4 | 89.7 | 91.8 | 100.0 | 99.3 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 97.4 | 80.0 | 99.4 | 98.7 | 97.4 | 99.4 | 90.3 | 97.4 | 89.7 | 91.0 | 92.3 | 99.4 | 99.4 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 96.6 | 61.5 | 95.9 | 99.3 | 95.3 | 95.3 | 74.3 | 90.5 | 81.1 | 76.4 | 83.1 | 97.3 | 98.0 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 96.4 | 72.8 | 94.2 | 100.0 | 96.4 | 97.1 | 86.1 | 94.2 | 83.3 | 84.7 | 86.2 | 100.0 | 98.5 |
Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
Percentage of participants achieving serotype-specific pneumococcal OPA titer >= LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. The OPA LLOQ in titers for each serotype: 1 = 1:18; 3 = 1:12; 4 = 1:21; 5 = 1:29; 6A = 1:37; 6B = 1:43; 7F = 1:210; 9V = 1:345; 14 = 1:35; 18C = 1:31; 19A = 1:18; 19F = 1:48; 23F = 1:13. (NCT01392378)
Timeframe: 1 month after the infant series
| Intervention | percentage of participants (Number) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4 (n = 37, 46, 42, 41, 61) | 6B (n = 36, 45, 43, 40, 62) | 9V (n = 37, 48, 42, 41, 65) | 14 (n = 38, 48, 41, 41, 64) | 18C (n = 37, 47, 41, 41, 62) | 19F (n = 37, 46, 41, 42, 63) | 23F (n = 38, 45, 42, 42, 63) | 1 (n = 42, 42, 43, 44, 74) | 3 (n = 41, 41, 39, 39, 69) | 5 (n = 42, 43, 44, 42, 73) | 6A (n = 46, 42, 39, 39, 76) | 7F (n = 46, 42, 40, 39, 76) | 19A (n = 42, 44, 41, 42, 74) | |
| 13vPnC + INFANRIX Hexa | 100.0 | 96.8 | 75.4 | 96.9 | 100.0 | 95.2 | 93.7 | 45.9 | 100.0 | 86.3 | 98.7 | 100.0 | 97.3 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 100.0 | 92.5 | 80.5 | 97.6 | 97.6 | 92.9 | 90.5 | 29.5 | 94.9 | 92.9 | 100.0 | 97.4 | 88.1 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 100.0 | 88.9 | 66.7 | 97.9 | 95.7 | 87.0 | 97.8 | 42.9 | 97.6 | 90.7 | 100.0 | 100.0 | 100.0 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 100.0 | 88.4 | 59.5 | 100.0 | 100.0 | 90.2 | 92.9 | 30.2 | 97.4 | 86.4 | 100.0 | 100.0 | 90.2 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 100.0 | 94.4 | 62.2 | 89.5 | 100.0 | 97.3 | 92.1 | 47.6 | 97.6 | 92.9 | 93.5 | 100.0 | 92.9 |
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1
Participants' core (rectal) temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree Celsius (degree C), greater than (>) 39 but <=40 degree C and >40 degree C. (NCT01392378)
Timeframe: Within 4 days after infant series Dose 1
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Fever >=38, <=39 degree C (n= 149,157,147,155,187) | Fever >39, <=40 degree C (n = 138,145,137,146,170) | Fever >40 degree C (n = 138,145,137,146,170) | |
| 13vPnC + INFANRIX Hexa | 41.7 | 1.2 | 0.0 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 34.2 | 0.7 | 0.0 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 45.2 | 1.4 | 0.0 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 18.4 | 0.7 | 0.0 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 32.9 | 1.4 | 0.0 |
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2
Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C. (NCT01392378)
Timeframe: Within 4 days after infant series Dose 2
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Fever >=38, <=39 degree C (n= 141,152,140,159,181) | Fever >39, <=40 degree C (n = 133,140,134,145,164) | Fever >40 degree C (n = 131,140,133,144,164) | |
| 13vPnC + INFANRIX Hexa | 39.8 | 3.7 | 0.0 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 44.0 | 1.4 | 0.0 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 42.8 | 0.7 | 0.0 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 21.4 | 1.5 | 0.0 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 26.2 | 1.5 | 0.0 |
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3
Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C. Report of fever >40 degrees C after 13vPnC Infant Series Dose 3 was confirmed as data entry error. (NCT01392378)
Timeframe: Within 4 days after infant series Dose 3
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Fever >=38, <=39 degree C (n= 136,146,135,141,175) | Fever >39, <=40 degree C (n = 129,137,125,136,167) | Fever >40 degree C (n = 128,136,126,135,166) | |
| 13vPnC + INFANRIX Hexa | 29.7 | 1.8 | 0.0 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 33.3 | 1.5 | 0.0 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 30.8 | 2.9 | 0.0 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 17.0 | 0.8 | 0.8 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 22.1 | 1.6 | 0.0 |
Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose
Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C. (NCT01392378)
Timeframe: Within 4 days after toddler dose
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Fever >=38, <=39 degree C (n= 133,140,134,144,162) | Fever >39, <=40 degree C (n = 128,127,118,123,150) | Fever >40 degree C (n = 123,125,117,122,150) | |
| 13vPnC + INFANRIX Hexa | 30.2 | 2.0 | 0.0 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 50.0 | 5.7 | 0.0 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 37.1 | 7.1 | 0.0 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 37.3 | 4.2 | 0.0 |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 31.6 | 5.5 | 0.0 |
Pain Score 120 Minutes After Study Medication Administration
Pain is measured on a visual analog scale 0=no pain and 10=worst pain imaginable. (NCT02268955)
Timeframe: 120 minutes post medication administration
| Intervention | score on a scale (Median) |
|---|---|
| Control Group: Adults Age 18-55 Years | 3.0 |
| IV Ibuprofen: Adults Age 18-55 Years | 0.3 |
Child Temperature (Degrees C)Over 6 Hours
Temperature was measured hourly using a temporal thermometer to monitor the child's temperature in degrees C. Temperature of 38 degrees C or higher was considered febrile. (NCT00267293)
Timeframe: 6 hours
| Intervention | degrees Celcius (Mean) |
|---|---|
| Group A: Ibuprofen Alone | 38.5 |
| Group B: Ibuprofen and Acetaminophen | 37.2 |
| Group C: Ibuprofen Then Acetaminophen | 36.9 |
Temperature Burden
Mean total body temperature burden above 37°C over 48 hours during which patient receives either control or intervention medication. (NCT03496545)
Timeframe: over 48 hours
| Intervention | Temperature in degrees Celsius (Mean) |
|---|---|
| Acetaminophen | 37.8 |
| Bromocriptine and Acetaminophen | 37.7 |
Total Time That Temperature is ≥ 38.3ºC
Time in minutes where the temperature is ≥ 38.3ºC during the 48 hours of control versus intervention administration. (NCT03496545)
Timeframe: 48 hours
| Intervention | Minutes (Mean) |
|---|---|
| Acetaminophen | 216 |
| Bromocriptine and Acetaminophen | 300 |
Total Time to First Temperature < 37.5ºC
Time in minutes it took after medication administration for the temperature to reach < 37.5ºC. (NCT03496545)
Timeframe: 48 hours
| Intervention | Minutes (Mean) |
|---|---|
| Acetaminophen | 253.5 |
| Bromocriptine and Acetaminophen | 556 |
Incidence of Adverse Events - Symptomatic Hypotension, Nausea and Headache
Episodes of symptomatic hypotension, including decrease in supine systolic and diastolic pressures of greater than 20mm and 10mm Hg respectively with patient reported accompanying symptoms of light headedness or dizziness and incidence of nausea and headache. (NCT03496545)
Timeframe: Nursing assessment at every shift during 48 hour study period after first drug administration
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| Decrease in blood pressure | Nausea | Headache | |
| Acetaminophen | 12 | 2 | 8 |
| Bromocriptine and Acetaminophen | 17 | 3 | 12 |
Number of Participants With Level 3 Postoperative Hemorrhage
Postoperative hemorrhage is defined as any history of bleeding occurring within the 14 day postoperative period. Hemorrhage will be stratified into 3 levels of severity. Level 1: includes children with a history of postoperative bleeding evaluated and/or treated by a physician in the emergency room, inpatient unit or operating room; Level 2: children requiring inpatient admission for postoperative bleeding regardless of the need for operative intervention; Level 3: children requiring inpatient admission and return to the operating room for control of post-tonsillectomy hemorrhage. (NCT01605903)
Timeframe: Data about post-tonsillectomy bleeding will be obtained after the end of a 14-day postoperative period.
| Intervention | Participants (Count of Participants) |
|---|---|
| Treatment With Ibuprofen | 10 |
| Treatment With Acetaminophen | 4 |
Faces Pain Score
Using the Faces Pain Scale, the pediatric patient will indicate his/her pain level at scheduled intervals (7 times per day) for 14 days post-surgery.The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain. For this analysis, participant pain scores were summed and the mean per group was calculated. Total summed scores could range from 0 to 980. (NCT02296840)
Timeframe: 2 weeks after surgery
| Intervention | units on a scale (Mean) |
|---|---|
| Ibuprofen | 158.95 |
| Hydrocodone-acetaminophen | 219.94 |
Number of Participants With Post-operative Bleeding
The occurrence of post-operative bleeding at the surgical site for each participant will be assessed by review of the participant's study records and clinical records and by questioning the caregiver in follow-up. If postoperative bleeding has occurred, details of the episode of bleeding will also be obtained (requirement for surgical intervention, observation at home, or observation at the hospital). (NCT02296840)
Timeframe: 2 weeks after surgery
| Intervention | Participants (Count of Participants) |
|---|---|
| Ibuprofen | 2 |
| Hydrocodone-acetaminophen | 0 |
Reviews
56 reviews available for ibuprofen and Fever
| Article | Year |
|---|---|
Comparison between Ibuprofen and Acetaminophen in the Treatment of Infectious Fever in Children: A Meta-Analysis.
Topics: Acetaminophen; Child; Fever; Humans; Ibuprofen; Odds Ratio; Retrospective Studies | 2022 |
Clinical management of fever in children in Brazil: practical recommendations from an expert panel.
Topics: Acetaminophen; Antipyretics; Brazil; Child; Fever; Humans; Ibuprofen | 2022 |
Common Selfcare Indications of Pain Medications in Children.
Topics: Acetaminophen; Adolescent; Analgesics, Non-Narcotic; Child; COVID-19; Fever; Humans; Ibuprofen; Pain | 2023 |
Intravenous ibuprofen in postoperative pain and fever management in adults: A systematic review and meta-analysis of randomized controlled trials.
Topics: Acetaminophen; Adult; Antipyretics; Fever; Humans; Ibuprofen; Pain, Postoperative; Randomized Contro | 2023 |
Paracetamol (acetaminophen) or non-steroidal anti-inflammatory drugs, alone or combined, for pain relief in acute otitis media in children.
Topics: Acetaminophen; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Child; Fever; Humans; | 2023 |
Comparison of Acetaminophen (Paracetamol) With Ibuprofen for Treatment of Fever or Pain in Children Younger Than 2 Years: A Systematic Review and Meta-analysis.
Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Child, Preschool; Female; Fever; Humans; Ibu | 2020 |
Ibuprofen Better than Acetaminophen for Reducing Fever, Pain in Young Children.
Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Fever; Humans; Ibuprofen; Incidence; Pediatr | 2021 |
Ibuprofen vs. Acetaminophen for Fever or Pain in Children Younger Than Two Years.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Fever; Humans; Ibuprofen; Infant; Pain; Patient Selection; | 2021 |
Acetaminophen and ibuprofen in the treatment of pediatric fever: a narrative review.
Topics: Acetaminophen; Administration, Intravenous; Analgesics, Non-Narcotic; Antipyretics; Child; Fever; Hu | 2021 |
[Revision of the Dutch College of General Practitioners practice guideline 'Children with fever'].
Topics: Acetaminophen; Child; Family Practice; Fever; General Practitioners; Humans; Ibuprofen; Netherlands; | 2017 |
Effectiveness of paracetamol versus ibuprofen administration in febrile children: A systematic literature review.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Antipyretics; Child; Child, Preschool; Fever; Humans; Ibupr | 2017 |
Efficacy and Safety of Ibuprofen in Infants Aged Between 3 and 6 Months.
Topics: Analgesia; Anti-Inflammatory Agents, Non-Steroidal; Fever; Humans; Ibuprofen; Infant; Pain; Pain Man | 2017 |
Working Towards an Appropriate Use of Ibuprofen in Children: An Evidence-Based Appraisal.
Topics: Abnormalities, Multiple; Age Factors; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Cerebellar Di | 2017 |
Symptomatic treatment of dengue: should the NSAID contraindication be reconsidered?
Topics: Anti-Inflammatory Agents, Non-Steroidal; Contraindications, Drug; Dengue; Fever; Hemorrhage; Humans; | 2019 |
Does combination treatment with ibuprofen and acetaminophen improve fever control?
Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Antipyretics; Child; Child, Preschool; Drug | 2013 |
Combined and alternating paracetamol and ibuprofen therapy for febrile children.
Topics: Acetaminophen; Antipyretics; Body Temperature; Child; Combined Modality Therapy; Fever; Humans; Ibup | 2013 |
A practical approach to the treatment of low-risk childhood fever.
Topics: Acetaminophen; Child; Fever; Humans; Ibuprofen | 2014 |
A practical approach to the treatment of low-risk childhood fever.
Topics: Acetaminophen; Child; Fever; Humans; Ibuprofen | 2014 |
A practical approach to the treatment of low-risk childhood fever.
Topics: Acetaminophen; Child; Fever; Humans; Ibuprofen | 2014 |
A practical approach to the treatment of low-risk childhood fever.
Topics: Acetaminophen; Child; Fever; Humans; Ibuprofen | 2014 |
A practical approach to the treatment of low-risk childhood fever.
Topics: Acetaminophen; Child; Fever; Humans; Ibuprofen | 2014 |
A practical approach to the treatment of low-risk childhood fever.
Topics: Acetaminophen; Child; Fever; Humans; Ibuprofen | 2014 |
A practical approach to the treatment of low-risk childhood fever.
Topics: Acetaminophen; Child; Fever; Humans; Ibuprofen | 2014 |
A practical approach to the treatment of low-risk childhood fever.
Topics: Acetaminophen; Child; Fever; Humans; Ibuprofen | 2014 |
A practical approach to the treatment of low-risk childhood fever.
Topics: Acetaminophen; Child; Fever; Humans; Ibuprofen | 2014 |
Combined and alternating paracetamol and ibuprofen therapy for febrile children.
Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Antipyretics; Child; Child, Preschool; Drug | 2014 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo.
Topics: Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Chemistry, Pharmaceutical; Child; Double-Blind Me | 2015 |
Paracetamol (acetaminophen) or non-steroidal anti-inflammatory drugs, alone or combined, for pain relief in acute otitis media in children.
Topics: Acetaminophen; Acute Disease; Analgesics, Non-Narcotic; Anti-Bacterial Agents; Anti-Inflammatory Age | 2016 |
A clinical and safety review of paracetamol and ibuprofen in children.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Child; Drug Overdo | 2017 |
[Research advance on pediatric antipyretic].
Topics: Acetaminophen; Analgesics, Non-Narcotic; Aspirin; Fever; Humans; Ibuprofen; Sulfonamides | 2008 |
Systematic review and meta-analysis of the clinical safety and tolerability of ibuprofen compared with paracetamol in paediatric pain and fever.
Topics: Acetaminophen; Algorithms; Analgesics, Non-Narcotic; Anaphylaxis; Child; Fever; Gastrointestinal Hem | 2009 |
Is combining or alternating antipyretic therapy more beneficial than monotherapy for febrile children?
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Combined Modality Therapy; Fever; Humans; Ibuprofen | 2009 |
Clinical safety and tolerability of ibuprofen compared with paracetamol in pediatric pain and fever. A systematic review.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Fever; Humans; Ibuprofen; Pain | 2009 |
Ibuprofen: pharmacology, efficacy and safety.
Topics: Adult; Animals; Anti-Inflammatory Agents, Non-Steroidal; Child; Dose-Response Relationship, Drug; Fe | 2009 |
Efficacy and safety of ibuprofen and acetaminophen in children and adults: a meta-analysis and qualitative review.
Topics: Acetaminophen; Adult; Age Factors; Analgesics, Non-Narcotic; Child; Female; Fever; Humans; Ibuprofen | 2010 |
Fever management: evaluating the use of ibuprofen and paracetamol.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Drug Administration Schedule; Emergency Nursing; Fem | 2010 |
Clinical inquiries. Does lowering a fever >101 degrees F in children improve clinical outcomes?
Topics: Acetaminophen; Analgesics, Non-Narcotic; Chickenpox; Cryotherapy; Fasciitis, Necrotizing; Fever; Hum | 2010 |
Fever without a localizing source.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Antipyretics; Bacteremia; Child, Preschool; Female; Fever; | 2011 |
[Efficacy and safety of ibuprofen and paracetamol in fever among children].
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Child; Drug Combin | 2011 |
Systematic review of studies comparing combined treatment with paracetamol and ibuprofen, with either drug alone.
Topics: Acetaminophen; Adolescent; Anti-Inflammatory Agents, Non-Steroidal; Antipyretics; Child; Child, Pres | 2011 |
Short-term acetylsalicylic acid (aspirin) use for pain, fever, or colds - gastrointestinal adverse effects: a meta-analysis of randomized clinical trials.
Topics: Acetaminophen; Adult; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Common Cold; Double-Blind Me | 2011 |
Pharmacokinetics of intravenous ibuprofen: implications of time of infusion in the treatment of pain and fever.
Topics: Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Biological Availability; Dose-Res | 2012 |
Acetaminophen and Ibuprofen overdosage.
Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Antipyretics; Chemical and Drug Induced Live | 2012 |
Efficacy and gastrointestinal risk of aspirin used for the treatment of pain and cold.
Topics: Acetaminophen; Aspirin; Common Cold; Dyspepsia; Fever; Gastrointestinal Tract; Humans; Ibuprofen; No | 2012 |
Alternating antipyretics in the treatment of fever in children: a systematic review of randomized clinical trials.
Topics: Acetaminophen; Antipyretics; Child; Drug Substitution; Drug Therapy, Combination; Fever; Humans; Ibu | 2012 |
Optimising the management of fever and pain in children.
Topics: Acetaminophen; Analgesics; Child; Comparative Effectiveness Research; Dose-Response Relationship, Dr | 2013 |
A general overview of the use of ibuprofen in paediatrics.
Topics: Acute Disease; Adolescent; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Juvenile; Child; Chil | 2003 |
The safety of ibuprofen suspension in children.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Child; Fev | 2003 |
Antipyretic efficacy and safety of ibuprofen and acetaminophen in children.
Topics: Acetaminophen; Child; Child, Preschool; Drug Administration Schedule; Fever; Humans; Ibuprofen; Infa | 2004 |
Efficacy and safety of acetaminophen vs ibuprofen for treating children's pain or fever: a meta-analysis.
Topics: Acetaminophen; Adolescent; Analgesics, Non-Narcotic; Child; Child, Preschool; Fever; Humans; Ibuprof | 2004 |
How safe is ibuprofen in febrile asthmatic children?
Topics: Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Child, Preschool; Contrai | 2004 |
Best evidence topic report. Non-steroidal anti-inflammatory drugs and exacerbations of asthma in children.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Asthma; Child; Emergencies; Fever; Humans; Ibuprofen; Male | 2004 |
Efficacy and safety of over-the-counter analgesics in the treatment of common cold and flu.
Topics: Acetaminophen; Adult; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Child; Child, Preschool; Com | 2006 |
[Answers to the questions on application of ibuprofen and acetaminophen in children with fever].
Topics: Acetaminophen; Child; Fever; Humans; Ibuprofen; Neonatology | 2007 |
A review of ibuprofen and acetaminophen use in febrile children and the occurrence of asthma-related symptoms.
Topics: Acetaminophen; Algorithms; Analgesics, Non-Narcotic; Asthma; Child; Fever; Hospitalization; Humans; | 2007 |
Use of ibuprofen in paediatric populations.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Chickenpox; Child; Fever; Humans; Ibuprofen; Infant, Newbor | 2007 |
[Using evidence-based nursing to explore the management of child fever].
Topics: Acetaminophen; Child; Evidence-Based Medicine; Fever; Humans; Ibuprofen | 2008 |
Towards evidence based emergency medicine: best BETs from the Manchester Royal Infirmary. Paracetamol or ibuprofen in febrile children.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child, Preschool; Emergency Medicine; Evidence-Based Medici | 1999 |
The effects of ibuprofen on eicosanoid synthesis in sepsis.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Cytokines; Disease Models, Anima | 1999 |
Childhood fever revisited.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Body Temperature; Child; Fever; Humans; Ibuprofen; Thermome | 2002 |
Antipyretics in children.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Aspirin; Child; Cyclooxygenase Inhibitors; Fever; Humans; I | 2002 |
Treating fever in children: paracetamol or ibuprofen?
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Effect Modifier, Epidemiologic; Evidence-Based Medic | 2002 |
Antipyretic therapy in the febrile child.
Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Child, Preschool; Drug Therapy, Com | 1992 |
Update on ibuprofen: review article.
Topics: Analgesia; Arthritis; Arthritis, Rheumatoid; Clinical Trials as Topic; Connective Tissue Diseases; D | 1986 |
Trials
87 trials available for ibuprofen and Fever
| Article | Year |
|---|---|
Panic or peace - prioritising infant welfare when medicating feverish infants: a grounded theory study of adherence in a paediatric clinical trial.
Topics: Acetaminophen; Asthma; Fever; Grounded Theory; Humans; Ibuprofen; Infant; Infant Welfare | 2022 |
Aggressive antipyretics in central nervous system malaria: Study protocol of a randomized-controlled trial assessing antipyretic efficacy and parasite clearance effects (Malaria FEVER study).
Topics: Acetaminophen; Animals; Antipyretics; Central Nervous System; Child; Fever; Histidine; Humans; Ibupr | 2022 |
Comparing the effect of body wash with marshmallow plant and lukewarm water on reducing the temperature of febrile children: a randomized clinical trial.
Topics: Acetaminophen; Child; Fever; Humans; Ibuprofen; Iran; Temperature; Water | 2022 |
A Multi-Center Evaluation of the Pharmacokinetics and Safety of Intravenous Ibuprofen in Infants 1-6 Months of Age.
Topics: Administration, Intravenous; Aged; Child; Female; Fever; Humans; Ibuprofen; Infant; Infant, Newborn; | 2023 |
Ibuprofen does not prevent postbronchoscopy fever in children undergoing broncho-alveolar lavage.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Bronchoalveolar Lavage; Bronchoscopy; Child; Child, Prescho | 2020 |
Ibuprofen versus paracetamol for treating fever in preschool children in Nigeria: a randomized clinical trial of effectiveness and safety.
Topics: Acetaminophen; Antipyretics; Body Temperature; Child, Preschool; Female; Fever; Hospitals, Teaching; | 2020 |
Comparison of intravenous ibuprofen and paracetamol in the treatment of fever: A randomized double-blind study.
Topics: Acetaminophen; Adult; Anti-Inflammatory Agents, Non-Steroidal; Antipyretics; Double-Blind Method; Em | 2021 |
Alternating Acetaminophen and Ibuprofen versus Monotherapies in Improvements of Distress and Reducing Refractory Fever in Febrile Children: A Randomized Controlled Trial.
Topics: Acetaminophen; Antipyretics; Child; Child, Preschool; Drug Administration Schedule; Drug Therapy, Co | 2017 |
The antipyretic efficacy and safety of propacetamol compared with dexibuprofen in febrile children: a multicenter, randomized, double-blind, comparative, phase 3 clinical trial.
Topics: Acetaminophen; Administration, Oral; Adolescent; Antipyretics; Child; Child, Preschool; Double-Blind | 2018 |
[In process].
Topics: Acetaminophen; Asthma; Child, Preschool; Disease Progression; Fever; Humans; Ibuprofen; Pain; Prospe | 2016 |
Dexibuprofen for fever in children with upper respiratory tract infection.
Topics: Adolescent; Anti-Inflammatory Agents, Non-Steroidal; Body Temperature; Child; Child, Preschool; Dose | 2013 |
The shortened infusion time of intravenous ibuprofen part 1: a multicenter, open-label, surveillance trial to evaluate safety and efficacy.
Topics: Adult; Aged; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Double-Blin | 2015 |
Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma.
Topics: Acetaminophen; Asthma; Child, Preschool; Double-Blind Method; Female; Fever; Humans; Ibuprofen; Inci | 2016 |
Effects of prophylactic ibuprofen and paracetamol administration on the immunogenicity and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugated vaccine (PHiD-CV) co-administered with DTPa-combined vaccines
Topics: Acetaminophen; Antibodies, Bacterial; Antipyretics; Diphtheria-Tetanus-acellular Pertussis Vaccines; | 2017 |
Antipyretic Efficacy and Safety of Ibuprofen Versus Acetaminophen Suspension in Febrile Children: Results of 2 Randomized, Double-Blind, Single-Dose Studies.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Antipyretics; Chil | 2017 |
A multicenter, randomized, open-label, active-comparator trial to determine the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for treatment of fever in hospitalized pediatric patients.
Topics: Acetaminophen; Administration, Oral; Adolescent; Antipyretics; Area Under Curve; Child; Child, Presc | 2017 |
A randomized study of fever prophylaxis and the immunogenicity of routine pediatric vaccinations.
Topics: Acetaminophen; Antibodies, Bacterial; Antipyretics; Chemoprevention; Diphtheria-Tetanus-Pertussis Va | 2017 |
Alternating antipyretics: antipyretic efficacy of acetaminophen versus acetaminophen alternated with ibuprofen in children.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Child, Preschool; Double-Blind Method; Female; Fever | 2008 |
Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): randomised controlled trial.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Body Temperature; Child; Child, Preschool; Drug Therapy, Co | 2008 |
Paracetamol plus ibuprofen for the treatment of fever in children (PITCH): economic evaluation of a randomised controlled trial.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Child, Preschool; Cost-Benefit Analysis; Drug Therap | 2008 |
The effects and safety of dexibuprofen compared with ibuprofen in febrile children caused by upper respiratory tract infection.
Topics: Administration, Oral; Adolescent; Analysis of Variance; Anti-Inflammatory Agents, Non-Steroidal; Chi | 2008 |
Antipyretic effect of ketoprofen.
Topics: Acetaminophen; Adolescent; Analgesics, Non-Narcotic; Analysis of Variance; Anti-Inflammatory Agents, | 2009 |
Paracetamol and ibuprofen for the treatment of fever in children: the PITCH randomised controlled trial.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Child, Preschool; Cost-Benefit Analysis; Double-Blin | 2009 |
Antibiotic prophylaxis in third molar surgery: A randomized double-blind placebo-controlled clinical trial using split-mouth technique.
Topics: Acetaminophen; Adult; Amoxicillin; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Bacterial Agen | 2010 |
Ketoprofen versus paracetamol (acetaminophen) or ibuprofen in the management of fever: results of two randomized, double-blind, double-dummy, parallel-group, repeated-dose, multicentre, phase III studies in children.
Topics: Acetaminophen; Administration, Oral; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroid | 2010 |
A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Critical Illness; Double-Blind Method; Drug-Related | 2010 |
A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Critical Illness; Double-Blind Method; Drug-Related | 2010 |
A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Critical Illness; Double-Blind Method; Drug-Related | 2010 |
A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Critical Illness; Double-Blind Method; Drug-Related | 2010 |
A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Critical Illness; Double-Blind Method; Drug-Related | 2010 |
A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Critical Illness; Double-Blind Method; Drug-Related | 2010 |
A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Critical Illness; Double-Blind Method; Drug-Related | 2010 |
A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Critical Illness; Double-Blind Method; Drug-Related | 2010 |
A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Critical Illness; Double-Blind Method; Drug-Related | 2010 |
Intravenous ibuprofen (IV-ibuprofen) controls fever effectively in adults with acute uncomplicated Plasmodium falciparum malaria but prolongs parasitemia.
Topics: Acute Disease; Adult; Animals; Antimalarials; Artemisinins; Artesunate; Double-Blind Method; Drug Th | 2010 |
Treatment with acetaminophen/paracetamol or ibuprofen alleviates post-dose symptoms related to intravenous infusion with zoledronic acid 5 mg.
Topics: Acetaminophen; Aged; Arthralgia; Body Temperature; Bone Density Conservation Agents; Diphosphonates; | 2012 |
Efficacy of standard doses of Ibuprofen alone, alternating, and combined with acetaminophen for the treatment of febrile children.
Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Antipyretics; Child; Child, Preschool; Dose- | 2010 |
Efficacy of standard doses of Ibuprofen alone, alternating, and combined with acetaminophen for the treatment of febrile children.
Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Antipyretics; Child; Child, Preschool; Dose- | 2010 |
Efficacy of standard doses of Ibuprofen alone, alternating, and combined with acetaminophen for the treatment of febrile children.
Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Antipyretics; Child; Child, Preschool; Dose- | 2010 |
Efficacy of standard doses of Ibuprofen alone, alternating, and combined with acetaminophen for the treatment of febrile children.
Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Antipyretics; Child; Child, Preschool; Dose- | 2010 |
A prospective randomized study to evaluate the antipyretic effect of the combination of acetaminophen and ibuprofen in neurological ICU patients.
Topics: Academic Medical Centers; Acetaminophen; Antipyretics; Body Temperature; Drug Therapy, Combination; | 2011 |
A prospective randomized study to evaluate the antipyretic effect of the combination of acetaminophen and ibuprofen in neurological ICU patients.
Topics: Academic Medical Centers; Acetaminophen; Antipyretics; Body Temperature; Drug Therapy, Combination; | 2011 |
A prospective randomized study to evaluate the antipyretic effect of the combination of acetaminophen and ibuprofen in neurological ICU patients.
Topics: Academic Medical Centers; Acetaminophen; Antipyretics; Body Temperature; Drug Therapy, Combination; | 2011 |
A prospective randomized study to evaluate the antipyretic effect of the combination of acetaminophen and ibuprofen in neurological ICU patients.
Topics: Academic Medical Centers; Acetaminophen; Antipyretics; Body Temperature; Drug Therapy, Combination; | 2011 |
Effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute ischemic stroke PISA, a phase II double-blind, randomized, placebo-controlled trial [ISRCTN98608690].
Topics: Acetaminophen; Acute Disease; Aged; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroida | 2003 |
A multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled, parallel-group comparison of diclofenac-K and ibuprofen for the treatment of adults with influenza-like symptoms.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Blind Method; Drug Administration | 2003 |
The antipyretic effect of ibuprofen and acetaminophen in children.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Body Temperature; Child; Child, Preschool; Fever; Half-Life | 2004 |
Corticosteroids, ibuprofen, and acetaminophen for IFNbeta-1a flu symptoms in MS: a randomized trial.
Topics: Acetaminophen; Adult; Analgesics, Non-Narcotic; Asthenia; Chills; Double-Blind Method; Drug Administ | 2004 |
[Antipyretic effectiveness of ibuprofen and paracetamol].
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Child, Preschool; Female; Fever; Humans; Ibuprofen; | 2005 |
[Randomized controlled study of S (+) -ismer of ibuprofen supporsitory].
Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Female; Fever; Humans; Ibuprofen; | 2004 |
Antipyretic treatment in young children with fever: acetaminophen, ibuprofen, or both alternating in a randomized, double-blind study.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child, Preschool; Double-Blind Method; Drug Therapy, Combin | 2006 |
Randomised controlled trial of combined paracetamol and ibuprofen for fever.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Child, Preschool; Drug Therapy, Combination; Emergen | 2006 |
Alternating ibuprofen and acetaminophen in the treatment of febrile children: a pilot study [ISRCTN30487061].
Topics: Acetaminophen; Administration, Oral; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroid | 2006 |
Antipyretic efficacy and tolerability of oral ibuprofen, oral dipyrone and intramuscular dipyrone in children: a randomized controlled trial.
Topics: Administration, Oral; Anti-Inflammatory Agents, Non-Steroidal; Child; Child, Preschool; Dipyrone; Fe | 2006 |
Ibuprofen versus paracetamol in pediatric fever: objective and subjective findings from a randomized, blinded study.
Topics: Acetaminophen; Child; Child, Preschool; Double-Blind Method; Female; Fever; Humans; Ibuprofen; Infan | 2007 |
Comparative evaluation of antipyretic activity of ibuprofen and aspirin in children with pyrexia of varied aetiology.
Topics: Aspirin; Child, Preschool; Female; Fever; Humans; Ibuprofen; Male; Respiratory Tract Infections; Tim | 1984 |
[A clinical study on the effect of K-708 (acemetacin)--a double blind comparative study with ibuprofen in upper respiratory tract inflammation with fever (author's transl)].
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials as Topic; Double-Blind Method; Femal | 1981 |
Comparative efficacy and tolerance of ibuprofen syrup and acetaminophen syrup in children with pyrexia associated with infectious diseases and treated with antibiotics.
Topics: Acetaminophen; Anti-Bacterial Agents; Child, Preschool; Double-Blind Method; Female; Fever; Humans; | 1994 |
Comparing efficacy and tolerability of ibuprofen and paracetamol in fever.
Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Body Temperature; Child; Child, Preschool; D | 1996 |
Choice of antipyretic in children.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Child; Child, Pres | 1995 |
Phase II trial of intravenous endotoxin in patients with colorectal and non-small cell lung cancer.
Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Bacterial Toxins; Carcinoma, Non-Small-Cell Lu | 1996 |
Evaluation of ibuprofen versus aspirin and paracetamol on efficacy and comfort in children with fever.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Body Temp | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
The effects of ibuprofen on the physiology and survival of patients with sepsis. The Ibuprofen in Sepsis Study Group.
Topics: Acidosis, Lactic; Double-Blind Method; Epoprostenol; Female; Fever; Hemodynamics; Humans; Ibuprofen; | 1997 |
Evaluation of sponging and antipyretic medication to reduce body temperature in febrile children.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Aspirin; Baths; Child, Preschool; Female; Fever; Humans; Ib | 1997 |
A comparison of ibuprofen versus acetaminophen with codeine in the young tonsillectomy patient.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal | 1997 |
A comparison of ibuprofen versus acetaminophen with codeine in the young tonsillectomy patient.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal | 1997 |
A comparison of ibuprofen versus acetaminophen with codeine in the young tonsillectomy patient.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal | 1997 |
A comparison of ibuprofen versus acetaminophen with codeine in the young tonsillectomy patient.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal | 1997 |
A comparison of ibuprofen versus acetaminophen with codeine in the young tonsillectomy patient.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal | 1997 |
A comparison of ibuprofen versus acetaminophen with codeine in the young tonsillectomy patient.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal | 1997 |
A comparison of ibuprofen versus acetaminophen with codeine in the young tonsillectomy patient.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal | 1997 |
A comparison of ibuprofen versus acetaminophen with codeine in the young tonsillectomy patient.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal | 1997 |
A comparison of ibuprofen versus acetaminophen with codeine in the young tonsillectomy patient.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal | 1997 |
Renal function after short-term ibuprofen use in infants and children.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Blood Urea Nitroge | 1997 |
Equivalent antipyretic activity of ibuprofen and paracetamol in febrile children.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Child; Child, Pres | 1997 |
Randomized, controlled trial of ibuprofen syrup administered during febrile illnesses to prevent febrile seizure recurrences.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Child, Preschool; Double-Blind Method; Female; Fever; Human | 1998 |
Effects of ibuprofen on the physiology and survival of hypothermic sepsis. Ibuprofen in Sepsis Study Group.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Epoprostenol; Female; Fever; Humans; Hypothermia; Ibuprofen | 1999 |
Cyclooxygenase-2 inhibition by rofecoxib reverses naturally occurring fever in humans.
Topics: Administration, Oral; Analysis of Variance; Animals; Body Temperature; Cyclooxygenase 2; Cyclooxygen | 1999 |
Parents' fear regarding fever and febrile seizures.
Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Attitude to Health; Body Temperature; Child, P | 1999 |
The safety of acetaminophen and ibuprofen among children younger than two years old.
Topics: Acetaminophen; Acute Disease; Analgesics, Non-Narcotic; Asthma; Bronchiolitis; Double-Blind Method; | 1999 |
Assessment of the efficacy and safety of paracetamol, ibuprofen and nimesulide in children with upper respiratory tract infections.
Topics: Acetaminophen; Acute Disease; Adolescent; Analgesics, Non-Narcotic; Analysis of Variance; Anti-Infla | 1999 |
Pharmacokinetic-Pharmacodynamic Modelling of the antipyretic effect of two oral formulations of ibuprofen.
Topics: Adolescent; Adult; Algorithms; Analgesics, Non-Narcotic; Analysis of Variance; Body Temperature; Chi | 2000 |
[Evaluation of the antipyretic safety and accuracy of two pediatric ibuprofen formulations].
Topics: Adolescent; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Body Temperature; Bod | 2000 |
Antipyretic effects of nimesulide, paracetamol and ibuprofen-paracetamol.
Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Child, Preschool; Double-Blind Method; Drug | 2000 |
Effect of endotoxin on ventilation and breath variability: role of cyclooxygenase pathway.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Blood Gas Analysis; Carbon Dioxide; Dyspnea; Endotox | 2001 |
Antipyretic effects of dipyrone versus ibuprofen versus acetaminophen in children: results of a multinational, randomized, modified double-blind study.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Analysis of Variance; Anti-Inflammatory Agents, Non-Steroid | 2001 |
Asthma morbidity after the short-term use of ibuprofen in children.
Topics: Acetaminophen; Age Factors; Ambulatory Care; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non | 2002 |
Both paracetamol and ibuprofen are equally effective in managing flu-like symptoms in relapsing-remitting multiple sclerosis patients during interferon beta-1a (AVONEX) therapy.
Topics: Acetaminophen; Adult; Chills; Female; Fever; Headache; Humans; Ibuprofen; Interferon beta-1a; Interf | 2002 |
Effectiveness and tolerability of ibuprofen-arginine versus paracetamol in children with fever of likely infectious origin.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Arginine; Child; Child, Preschool; Double-Blind Method; Dru | 2002 |
Pharmacokinetics and pharmacodynamics of ibuprofen isomers and acetaminophen in febrile children.
Topics: Acetaminophen; Child; Child, Preschool; Dose-Response Relationship, Drug; Female; Fever; Humans; Ibu | 1992 |
Efficacy of ibuprofen in pediatric patients with fever.
Topics: Body Temperature; Child; Child, Preschool; Double-Blind Method; Female; Fever; Heart Rate; Humans; I | 1992 |
Antipyretic efficacy of ibuprofen vs acetaminophen.
Topics: Acetaminophen; Body Temperature; Child; Child, Preschool; Double-Blind Method; Female; Fever; Humans | 1992 |
Comparison of multidose ibuprofen and acetaminophen therapy in febrile children.
Topics: Acetaminophen; Body Temperature; Child; Child, Preschool; Double-Blind Method; Drug Administration S | 1992 |
A dose ranging study of ibuprofen suspension as an antipyretic.
Topics: Child, Preschool; Double-Blind Method; Drug Administration Schedule; Female; Fever; Humans; Ibuprofe | 1991 |
Single-dose, placebo-controlled comparative study of ibuprofen and acetaminophen antipyresis in children.
Topics: Acetaminophen; Administration, Oral; Anti-Bacterial Agents; Body Temperature; Body Weight; Child; Ch | 1991 |
Detection of interleukin 8 and tumor necrosis factor in normal humans after intravenous endotoxin: the effect of antiinflammatory agents.
Topics: Adult; Endotoxins; Escherichia coli; Female; Fever; Humans; Ibuprofen; Injections, Intravenous; Inte | 1991 |
Ibuprofen versus paracetamol for the treatment of fever in children.
Topics: Acetaminophen; Child; Child, Preschool; Fever; Humans; Ibuprofen; Infant; Research Design | 1990 |
A double-blind dose-ranging trial with paediatric ibuprofen.
Topics: Body Temperature; Child, Preschool; Double-Blind Method; Drug Administration Schedule; Female; Fever | 1990 |
A double-blind comparison of ibuprofen and paracetamol in juvenile pyrexia.
Topics: Acetaminophen; Body Temperature; Child; Child, Preschool; Double-Blind Method; Drug Administration S | 1990 |
Adverse effects of aspirin, acetaminophen, and ibuprofen on immune function, viral shedding, and clinical status in rhinovirus-infected volunteers.
Topics: Acetaminophen; Adult; Antibodies, Viral; Aspirin; Common Cold; Double-Blind Method; Female; Fever; H | 1990 |
Comparative evaluation of the antipyretic efficacy of ibuprofen and paracetamol.
Topics: Acetaminophen; Child; Child, Preschool; Female; Fever; Humans; Ibuprofen; Infant; Male | 1990 |
Comparison of nonsteroidal anti-inflammatory drugs, ibuprofen and flurbiprofen, with methylprednisolone and placebo for acute pain, swelling, and trismus.
Topics: Adult; Double-Blind Method; Evaluation Studies as Topic; Female; Fever; Flurbiprofen; Humans; Ibupro | 1990 |
Comparison of nonsteroidal anti-inflammatory drugs, ibuprofen and flurbiprofen, with methylprednisolone and placebo for acute pain, swelling, and trismus.
Topics: Adult; Double-Blind Method; Evaluation Studies as Topic; Female; Fever; Flurbiprofen; Humans; Ibupro | 1990 |
Comparison of nonsteroidal anti-inflammatory drugs, ibuprofen and flurbiprofen, with methylprednisolone and placebo for acute pain, swelling, and trismus.
Topics: Adult; Double-Blind Method; Evaluation Studies as Topic; Female; Fever; Flurbiprofen; Humans; Ibupro | 1990 |
Comparison of nonsteroidal anti-inflammatory drugs, ibuprofen and flurbiprofen, with methylprednisolone and placebo for acute pain, swelling, and trismus.
Topics: Adult; Double-Blind Method; Evaluation Studies as Topic; Female; Fever; Flurbiprofen; Humans; Ibupro | 1990 |
Ibuprofen, acetaminophen, and placebo treatment of febrile children.
Topics: Acetaminophen; Administration, Oral; Adolescent; Child; Child, Preschool; Clinical Trials as Topic; | 1989 |
A single-blind parallel group study investigating the antipyretic properties of ibuprofen syrup versus acetylsalicylic acid syrup in febrile children.
Topics: Aspirin; Child; Child, Preschool; Clinical Trials as Topic; Female; Fever; Humans; Ibuprofen; Infant | 1988 |
Induction of prostaglandin synthesis as the mechanism responsible for the chills and fever produced by infusing amphotericin B.
Topics: Adolescent; Adult; Amphotericin B; Animals; Child; Child, Preschool; Clinical Trials as Topic; Dinop | 1987 |
Update on ibuprofen: review article.
Topics: Analgesia; Arthritis; Arthritis, Rheumatoid; Clinical Trials as Topic; Connective Tissue Diseases; D | 1986 |
A comparative study of two dosage levels of ibuprofen syrup in children with pyrexia.
Topics: Child; Child, Preschool; Clinical Trials as Topic; Dose-Response Relationship, Drug; Female; Fever; | 1985 |
Antipyretic activity of ibuprofen and paracetamol in children with pyrexia.
Topics: Acetaminophen; Child; Child, Preschool; Clinical Trials as Topic; Female; Fever; Humans; Ibuprofen; | 1985 |
Antipyretic activity of ibuprofen (Brufen).
Topics: Adult; Aspirin; Double-Blind Method; Fever; Humans; Ibuprofen; Male | 1973 |
Other Studies
143 other studies available for ibuprofen and Fever
| Article | Year |
|---|---|
Synthesis and antiinflammatory activity of [(cycloalkylmethyl)phenyl]acetic acids and related compounds.
Topics: Analgesics; Animals; Chemical Phenomena; Chemistry; Female; Fever; Ibuprofen; Indomethacin; Inflamma | 1984 |
Does immunosuppressive property of non-steroidal anti-inflammatory drugs (NSAIDs) reduce COVID-19 vaccine-induced systemic side effects?
Topics: Acetaminophen; Adolescent; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; COVID-19 Vaccines; Fati | 2021 |
Acetaminophen Versus Ibuprofen for Fever Reduction in the Pediatric Emergency Department.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Child; Drug Therap | 2023 |
Acetaminophen Versus Ibuprofen for Fever Reduction in the Pediatric Emergency Department.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Child; Drug Therap | 2023 |
Acetaminophen Versus Ibuprofen for Fever Reduction in the Pediatric Emergency Department.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Child; Drug Therap | 2023 |
Acetaminophen Versus Ibuprofen for Fever Reduction in the Pediatric Emergency Department.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Child; Drug Therap | 2023 |
Treatment of fever and associated symptoms in the emergency department: which drug to choose?
Topics: Acetaminophen; Adult; Aged; Bacteriophages; Emergency Service, Hospital; Fever; Humans; Ibuprofen; M | 2023 |
Antipyretic Efficacy of Acetaminophen and Ibuprofen in Critically Ill Pediatric Patients.
Topics: Acetaminophen; Antipyretics; Body Temperature; Child; Child, Preschool; Critical Illness; Female; Fe | 2019 |
The use of ibuprofen to treat fever in COVID-19: A possible indirect association with worse outcome?
Topics: Acetaminophen; Antipyretics; COVID-19 Drug Treatment; Fever; Humans; Ibuprofen; Models, Theoretical; | 2020 |
Ibuprofen use and clinical outcomes in COVID-19 patients.
Topics: Acetaminophen; Adult; Antipyretics; COVID-19; COVID-19 Drug Treatment; Female; Fever; Humans; Ibupro | 2020 |
Fever response to ibuprofen in viral and bacterial childhood infections.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Antipyretics; Bacterial Infections; Cross-Sectional | 2021 |
Paracetamol or ibuprofen for fever or pain in children under 2 years old.
Topics: Acetaminophen; Antipyretics; Child; Fever; Humans; Ibuprofen; Infant; Pain | 2021 |
Assessment of pharmacological activities of Lygodium microphyllum Cav. leaves in the management of pain, inflammation, pyrexia, diarrhea, and helminths: In vivo, in vitro and in silico approaches.
Topics: Albendazole; Analgesics; Animals; Anthelmintics; Anti-Inflammatory Agents; Antidiarrheals; Antipyret | 2021 |
Community use of paracetamol and ibuprofen in children with fever.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Fever; Humans; Ibuprofen; Prospective Studies | 2021 |
A risk score for pericarditis recurrence.
Topics: Adult; Age Factors; Aged; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Chest Pain; Colchicine; | 2021 |
Severe polyarthralgia, high-grade fever, diffuse maculopapular rash on trunk and extremities · Dx?
Topics: Acetaminophen; Adult; Analgesics, Non-Narcotic; Ankle; Anti-Inflammatory Agents; Arthralgia; Caribbe | 2017 |
Synergistic analgesic, anti-pyretic and anti-inflammatory effects of extra virgin olive oil and ibuprofen in different experimental models of albino mice.
Topics: Acetic Acid; Albinism; Analgesics; Animals; Anti-Inflammatory Agents; Antipyretics; Carrageenan; Din | 2017 |
Antipyretic Medication Exposures Among Young Children Reported to US Poison Centers, 2000-2015.
Topics: Acetaminophen; Age Distribution; Antipyretics; Child; Child, Preschool; Confidence Intervals; Databa | 2018 |
Ibuprofen and Paracetamol: Acceptably Safe for All?
Topics: Acetaminophen; Analgesics, Non-Narcotic; Fever; Humans; Ibuprofen | 2018 |
AGEP from a dog bite treated with Ibuprofen.
Topics: Acute Generalized Exanthematous Pustulosis; Analgesics, Non-Narcotic; Animals; Anti-Bacterial Agents | 2018 |
Antipyretic effect of phytol, possibly via 5KIR-dependent COX-2 inhibition pathway.
Topics: Acetaminophen; Animals; Anti-Inflammatory Agents, Non-Steroidal; Antipyretics; Cyclooxygenase 1; Cyc | 2019 |
IBUPROFEN-INDUCED ASEPTIC MENINGITIS: A CASE REPORT.
Topics: Adolescent; Anti-Inflammatory Agents, Non-Steroidal; Diagnosis, Differential; Drug Hypersensitivity; | 2019 |
Effects of Bai-Hu decoction on fever induced by lipopolysaccharide.
Topics: Animals; Antipyretics; Body Temperature; Drugs, Chinese Herbal; Fever; Hypothalamus; Ibuprofen; Inte | 2013 |
Management of children's fever by parents and caregivers: Practical measurement of functional health literacy.
Topics: Acetaminophen; Antipyretics; Australia; Caregivers; Child, Preschool; Female; Fever; Health Literacy | 2014 |
Is fever treated more promptly than pain in the pediatric emergency department?
Topics: Acetaminophen; Adolescent; Age Factors; Analgesics, Non-Narcotic; Antipyretics; Child; Child, Presch | 2014 |
Adherence among Italian paediatricians to the Italian guidelines for the management of fever in children: a cross sectional survey.
Topics: Acetaminophen; Administration, Rectal; Antipyretics; Child; Cross-Sectional Studies; Fever; Guidelin | 2013 |
[How to treat pediatric fever in 2013 with little evidence-based?].
Topics: Acetaminophen; Child; Evidence-Based Practice; Fever; Humans; Ibuprofen; Seizures, Febrile | 2014 |
Cochrane in context: Combined and alternating paracetamol and ibuprofen therapy for febrile children.
Topics: Acetaminophen; Antipyretics; Child; Child, Preschool; Drug Therapy, Combination; Fever; Humans; Ibup | 2014 |
Drug-induced liver injury with serious multiform exudative erythema following the use of an over-the-counter medication containing ibuprofen.
Topics: Adult; Asian People; Chemical and Drug Induced Liver Injury; Drug Eruptions; Erythema; Female; Fever | 2015 |
Paracetamol is no more likely to exacerbate asthma in children than ibuprofen, shows study.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Child; Fev | 2016 |
Ibuprofen induced DRESS Syndrome in a Child.
Topics: Child; Drug Hypersensitivity Syndrome; Exanthema; Fever; Humans; Ibuprofen; Male | 2016 |
Hand-Foot and Mouth Dısease and Reactıve Arthritis: An Unusual Paediatric Case.
Topics: Animals; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Reactive; Child, Preschool; Coxsackievi | 2016 |
National modulators of symptomatic fever management in children: comparative analysis of survey data.
Topics: Acetaminophen; Administration, Rectal; Antipyretics; Female; Fever; Humans; Ibuprofen; Infant; Italy | 2018 |
Association of Acetaminophen and Ibuprofen Use With Wheezing in Children With Acute Febrile Illness.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Antipyretics; Asthma; Child; Child, Preschool; Cross-Sectio | 2017 |
Parental Approach to the Prevention and Management of Fever and Pain Following Childhood Immunizations: A Survey Study.
Topics: Acetaminophen; Adult; Analgesics; Antipyretics; Caregivers; Cross-Sectional Studies; Culture; Female | 2017 |
Acetaminophen versus Ibuprofen in Mild Persistent Asthma.
Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Double-Blind Method; Fever; Humans; | 2016 |
Acetaminophen versus Ibuprofen in Mild Persistent Asthma.
Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Asthma; Double-Blind Method; Fever; Humans; | 2016 |
Systemic onset juvenile idiopathic arthritis--its unusual presentation.
Topics: Arthralgia; Arthritis, Juvenile; Diagnosis, Differential; Drug Therapy, Combination; Exanthema; Feve | 2008 |
Antipyretic treatment for feverish young children in primary care.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Child, Preschool; Fever; Humans; Ibuprofen; Infant; | 2008 |
Combining paracetamol and ibuprofen for fever in children.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Drug Therapy, Combination; Fever; Humans; Ibuprofen | 2008 |
Ibuprofen increases soft tissue infections in children.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Fever; Humans; Ibuprofen; Soft Tissue Infections | 2008 |
Paracetamol with ibuprofen: Ibuprofen is a marker of soft tissue infection.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Chickenpox; Child; Fever; Humans; Ibuprofen; Soft Tissue In | 2008 |
Reduction of nuclear peroxisome proliferator-activated receptor gamma expression in methamphetamine-induced neurotoxicity and neuroprotective effects of ibuprofen.
Topics: Animals; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Body Temperature; Central Nervous System | 2009 |
. . . And which works better on fever--acetaminophen, ibuprofen, or both?
Topics: Acetaminophen; Age Factors; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Child | 2008 |
Fever: to treat or not to treat?
Topics: Acetaminophen; Analgesics, Non-Narcotic; Drug Therapy, Combination; Fever; Humans; Ibuprofen; Treatm | 2008 |
Acute non-oliguric kidney failure and cholestatic hepatitis induced by ibuprofen and acetaminophen: a case report.
Topics: Acetaminophen; Acute Kidney Injury; Analgesics, Non-Narcotic; Chemical and Drug Induced Liver Injury | 2009 |
Characterization and pharmacological evaluation of febrile response on zymosan-induced arthritis in rats.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Animals; Arthritis, Experimental; Body Temperature; Celecox | 2009 |
Defunct gadgets and changing times.
Topics: Acquired Immunodeficiency Syndrome; Amoxicillin; Anti-HIV Agents; Anti-Inflammatory Agents, Non-Ster | 2009 |
Ethnic differences in parental perceptions and management of childhood fever.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Black or African American; Body Temperature; Child; Child, | 2010 |
Effects of prenatal immune activation on hippocampal neurogenesis in the rat.
Topics: Age Factors; Analysis of Variance; Animals; Animals, Newborn; Anti-Inflammatory Agents, Non-Steroida | 2009 |
A strategy for evaluating antipyretic efficacy of Chinese herbal medicines based on UV spectra fingerprints.
Topics: Animals; Bupleurum; Drugs, Chinese Herbal; Evaluation Studies as Topic; Female; Fever; Flowers; Fors | 2009 |
Management of fever in children: summary of the Italian Pediatric Society guidelines.
Topics: Acetaminophen; Age Factors; Analgesics, Non-Narcotic; Axilla; Body Temperature; Body Weight; Child; | 2009 |
Intravenous ibuprofen (Caldolor).
Topics: Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Drug Interactions; Fever; Humans; | 2010 |
Caldolor: old drug, new route.
Topics: Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Fever; Humans; Ibuprofen; Injecti | 2010 |
A 27-year-old Cambodian woman with fever, lymphadenopathy, and arthritis.
Topics: Acquired Immunodeficiency Syndrome; Adult; Anti-Inflammatory Agents, Non-Steroidal; Arthritis; Asian | 2010 |
Hot times in the intensive care unit.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Critical Illness; Fever; Humans; Ibuprofen; Infusions, Intr | 2010 |
Treatment of pediatric fever: Are acetaminophen and ibuprofen equivalent?
Topics: Acetaminophen; Antipyretics; Child; Child, Preschool; Family Practice; Fever; Humans; Ibuprofen; Inf | 2010 |
Cyclooxygenase-independent mechanism of ibuprofen-induced antipyresis: the role of central vasopressin V₁ receptors.
Topics: Animals; Antipyretics; Arginine Vasopressin; Dinoprostone; Dose-Response Relationship, Drug; Fever; | 2011 |
Pediatric rash and joint pain: a case review.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Ankle Joint; Anti-Bacterial Agents; Arthralgia; Ceftriaxone | 2010 |
Premarketing surveillance of ibuprofen suppositories in febrile children.
Topics: Administration, Rectal; Adult; Antipyretics; Child; Child, Preschool; Drug Administration Schedule; | 2011 |
Ibuprofen transdermal ethosomal gel: characterization and efficiency in animal models.
Topics: Administration, Cutaneous; Analgesics, Non-Narcotic; Animals; Antipyretics; Disease Models, Animal; | 2010 |
Antipyretic therapy for influenza infection--benefit or harm?
Topics: Acetaminophen; Adult; Animals; Antipyretics; Child; Fever; Humans; Ibuprofen; Influenza, Human; Mice | 2011 |
Fever control in the NICU: is there still a simpler and cheaper solution?
Topics: Acetaminophen; Antipyretics; Fever; Humans; Ibuprofen; Intensive Care Units; Intracranial Hemorrhage | 2011 |
AAP reports on the use of antipyretics for fever in children.
Topics: Acetaminophen; Antipyretics; Child; Drug Therapy, Combination; Fever; Humans; Ibuprofen; Practice Gu | 2012 |
[Ibuprofen is more effective than paracetamol in lowering the temperature in febrile children].
Topics: Acetaminophen; Analgesics, Non-Narcotic; Antipyretics; Child; Drug Therapy, Combination; Fever; Huma | 2012 |
Intravenous ibuprofen: in adults for pain and fever.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials as Topic; Double-Blind Method; Fever; Human | 2012 |
Alternating acetaminophen and ibuprofen for pain in children.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Child; Child, Pres | 2012 |
Update of the 2009 Italian Pediatric Society Guidelines about management of fever in children.
Topics: Acetaminophen; Age Factors; Antipyretics; Axilla; Body Temperature; Child; Child, Preschool; Fever; | 2012 |
Non-prescription medicines for pain and fever--a comparison of recommendations and counseling from staff in pharmacy and general sales stores.
Topics: Acetaminophen; Analgesics; Antipyretics; Aspirin; Child; Commerce; Contraindications; Counseling; Fe | 2013 |
Fever phobia revisited.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child, Preschool; Drug Therapy, Combination; Fever; Humans; | 2004 |
Ibuprofen or acetaminophen in children? As the debate continues, the evidence may favor ibuprofen.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Child; Fever; Huma | 2004 |
Hypothermia following fever.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Female; Fever; Humans; Hypothermia; Ibuprofen; Infant | 2004 |
[Ibuprofen: a febrile rumor].
Topics: Anti-Inflammatory Agents, Non-Steroidal; Chickenpox; Child; Child Welfare; Contraindications; Fever; | 2005 |
[Aspirin, paracetamol, ibuprofen: analgesics in the family medicine cabinet].
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Contraind | 2005 |
[Familial use of ibuprofen in febrile children: a prospective study in the emergency room of an hospital in Lille].
Topics: Acetaminophen; Adolescent; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Child; | 2005 |
Immunizations. Can fever-reducers prevent redness from DTP shots?
Topics: Acetaminophen; Anti-Inflammatory Agents; Child; Diphtheria-Tetanus-Pertussis Vaccine; Drug Eruptions | 2006 |
[Change in habits among the population in the management of childhood fever].
Topics: Acetaminophen; Child; Child, Preschool; Fever; Habits; Humans; Ibuprofen; Infant | 2006 |
Antipyretic drugs for children.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Drug Combinations; Fever; Humans; Ibuprofen | 2006 |
Alternating acetaminophen and ibuprofen in children may cause parental confusion and is dangerous.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Child, Preschool; Confusion; Drug Administration Sch | 2006 |
Concerns over alternating acetaminophen and ibuprofen for fever.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Confusion; Drug Therapy, Combination; Fever; Humans; | 2006 |
Determinants of antipyretic misuse in children up to 5 years of age: a cross-sectional study.
Topics: Acetaminophen; Administration, Oral; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroid | 2006 |
Ibuprofen-induced fever in Sjogren's syndrome.
Topics: Aged; Analgesics, Non-Narcotic; Drug Hypersensitivity; Female; Fever; Humans; Ibuprofen; Meningitis, | 2006 |
Endotoxin fever in granulocytopenic rats: evidence that brain cyclooxygenase-2 is more important than circulating prostaglandin E(2).
Topics: Animals; Bacterial Infections; Brain; Cyclooxygenase 2; Cyclooxygenase Inhibitors; Dinoprostone; Fev | 2006 |
Tramadol infusion for the pain management in sickle cell disease: a case report.
Topics: Abdominal Pain; Acetaminophen; Analgesics, Non-Narcotic; Analgesics, Opioid; Anemia, Sickle Cell; Ch | 2007 |
57-year-old Asian-American man with Kikuchi's disease.
Topics: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Arthralgia; Asian; Biopsy; Diagno | 2006 |
Alternating antipyretics for fever reduction in children: an unfounded practice passed down to parents from pediatricians.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child, Preschool; Drug Administration Schedule; Fever; Heal | 2007 |
Treatment of fever and over-the-counter medicines.
Topics: Adult; Analgesics, Non-Narcotic; Child; Child, Preschool; England; Female; Fever; Health Knowledge, | 2007 |
Antipyretic drug use in children in French office based medical practice.
Topics: Acetaminophen; Age Factors; Analgesics, Non-Narcotic; Aspirin; Child; Child, Preschool; Drug Therapy | 2007 |
Over-the-counter medication use for childhood fever: a cross-sectional study of Australian parents.
Topics: Acetaminophen; Adult; Analgesics, Non-Narcotic; Child, Preschool; Cross-Sectional Studies; Female; F | 2007 |
Alternating acetaminophen with ibuprofen for fever: is this a problem?
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child, Preschool; Drug Therapy, Combination; Fever; Humans; | 2007 |
Question from the clinician: alternating acetaminophen and ibuprofen in the treatment of fever.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Drug Administration Schedule; Drug Therapy, Combinat | 2007 |
When the child has a fever.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Diagnosis, Differential; Fever; Humans; Ibuprofen; P | 2008 |
Effect of ibuprofen on fever and metabolic changes induced by continuous infusion of leukocytic pyrogen (interleukin 1) or endotoxin.
Topics: Animals; Drug Evaluation, Preclinical; Endotoxins; Fever; Guinea Pigs; Humans; Ibuprofen; Interleuki | 1983 |
Role of arachidonate metabolism in the immunoregulatory function of human leukocytic pyrogen/lymphocyte-activating factor/interleukin 1.
Topics: 4,5-Dihydro-1-(3-(trifluoromethyl)phenyl)-1H-pyrazol-3-amine; 5,8,11,14-Eicosatetraynoic Acid; Anima | 1983 |
Comparative study of the antipyretic effect of ibuprofen (oral suspension) and paracetamol (suppositories) in paediatrics.
Topics: Acetaminophen; Administration, Oral; Body Temperature; Child; Child, Preschool; Female; Fever; Human | 1984 |
Ibuprofen: a severe systemic reaction.
Topics: Amoxicillin; Dopamine; Female; Fever; Gingivitis; Humans; Hypotension; Ibuprofen; Middle Aged; Respi | 1983 |
Demonstration of a circulating suppressor factor of thymocyte proliferation during endotoxin fever in humans.
Topics: Adult; Animals; Blood; Cell Division; Endotoxins; Female; Fever; Hot Temperature; Humans; Ibuprofen; | 1981 |
Oral antipyretic therapy evaluation of the propionic acid derivatives ibuprofen, ketoprofen, fenoprofen and naproxen.
Topics: Administration, Oral; Anti-Inflammatory Agents, Non-Steroidal; Dose-Response Relationship, Drug; Fen | 1980 |
A toxicological and pharmacological study of ibuprofen guaiacol ester (AF 2259) in the rat.
Topics: Animals; Anti-Inflammatory Agents, Non-Steroidal; Behavior, Animal; Digestive System; Edema; Female; | 1980 |
Tolmetin-induced aseptic meningitis.
Topics: Adult; Female; Fever; Humans; Ibuprofen; Knee; Lupus Erythematosus, Systemic; Meningitis; Meningitis | 1981 |
Effect of ibuprofen on monocyte activation by liposome-encapsulated muramyl tripeptide phosphatidylethanolamine (CGP 19835A): can ibuprofen reduce fever and chills without compromising immune stimulation?
Topics: Acetylmuramyl-Alanyl-Isoglutamine; Adjuvants, Immunologic; Cytotoxicity Tests, Immunologic; Drug Car | 1993 |
NS-398, a novel non-steroidal anti-inflammatory drug with potent analgesic and antipyretic effects, which causes minimal stomach lesions.
Topics: Animals; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Experimental; Carrageenan; Cyclooxygena | 1993 |
Supportive care during aldesleukin therapy for patients infected with human immunodeficiency virus.
Topics: Acetaminophen; Adult; Analgesics, Non-Narcotic; Antiemetics; Female; Fever; HIV Infections; Humans; | 1997 |
Suppression of fever and the acute-phase response in a patient with juvenile chronic arthritis treated with monoclonal antibody to tumour necrosis factor-alpha (cA2).
Topics: Acute-Phase Reaction; Adolescent; Anti-Inflammatory Agents, Non-Steroidal; Antibodies, Monoclonal; A | 1997 |
Ibuprofen and/or acetaminophen: what price for "euthermia"?
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Body Temperature; | 1997 |
Ibuprofen and/or acetaminophen: what price for "euthermia"?
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Chemistry, Pharmac | 1997 |
Ibuprofen use in pediatric patients.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Child; Child, Preschool; Fever; Humans; Ibuprofen; Infant | 1998 |
Acetaminophen: a clarification.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Child; Fever; Huma | 1998 |
Combined antipyretic therapy: another potential source of chronic acetaminophen toxicity.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Chronic Disease; Drug Interactions; Drug Therapy, Co | 1998 |
Detection of macrophage inflammatory protein (MIP)-1alpha and MIP-1beta during experimental endotoxemia and human sepsis.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antigens, CD; Chemokine CCL3; Chemokine CCL4; Child; Cyc | 1999 |
Adult onset Still's disease associated with Epstein-Barr virus infection in a 66-year-old woman.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Antibodies, Antinuclear; Antirheumatic Agents; Arthralgia; | 1998 |
Parental guidance suggested. Pediatric fever and pain relief require expert input.
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Child, Preschool; Education; Fever; Humans; Ibuprofe | 1999 |
Ibuprofen treatment versus gradual introduction of interferon beta-1b in patients with MS.
Topics: Acetaminophen; Drug Administration Schedule; Fever; Humans; Hypothalamus; Ibuprofen; Interferon beta | 2000 |
Life-threatening illness in a nontransfusable patient: a health care challenge.
Topics: Abdominal Pain; Adult; Analgesics, Non-Narcotic; Anemia, Iron-Deficiency; Appendicitis; Epoetin Alfa | 2000 |
[Analysis of prognostic factors for the antipyretic response to ibuprofen].
Topics: Age Factors; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Body Temperature; Ch | 2000 |
Invasive group A streptococcal infection and nonsteroidal antiinflammatory drug use among children with primary varicella.
Topics: Acetaminophen; Adolescent; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Case-C | 2001 |
Toxicity of over-the-counter cough and cold medications.
Topics: Acetaminophen; Antitussive Agents; Bradycardia; Brompheniramine; Cardiovascular Diseases; Child, Pre | 2001 |
Alternating antipyretics: is this an alternative?
Topics: Acetaminophen; Acute Kidney Injury; Analgesics, Non-Narcotic; Cyclooxygenase Inhibitors; Drug Synerg | 2001 |
Ibuprofen induced acute renal failure in an infant.
Topics: Acute Kidney Injury; Female; Fever; Follow-Up Studies; Humans; Ibuprofen; Infant; Kidney Function Te | 2001 |
[Use of alternating antipyretics in the treatment of fever in Spain].
Topics: Acetaminophen; Analgesics, Non-Narcotic; Child; Child, Preschool; Fever; Humans; Ibuprofen; Infant; | 2001 |
PISA. The effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute stroke: protocol for a phase II double-blind randomised placebo-controlled trial [ISRCTN98608690].
Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Body Temperature; Clinical Trials, Phase II | 2002 |
Acute adverse reactions to ibuprofen in systemic lupus erythematosus.
Topics: Acute Disease; Adult; Arthritis; Drug Hypersensitivity; Female; Fever; Headache; Humans; Hypotension | 1979 |
Oral antipyretic therapy.
Topics: Acetaminophen; Administration, Oral; Aminopyrine; Aspirin; Child; Child, Preschool; Drug Evaluation; | 1976 |
Letter: Fever from ibuprofen in a patient with lupus erythematosus.
Topics: Adult; Female; Fever; Humans; Ibuprofen; Lupus Erythematosus, Systemic; Phenylpropionates | 1976 |
Drugs for childhood fever.
Topics: Acetaminophen; Child; Contraindications; Fever; Humans; Ibuprofen | 1992 |
Effect of age on ibuprofen pharmacokinetics and antipyretic response.
Topics: Acute Disease; Aging; Axilla; Body Temperature; Child; Child, Preschool; Drug Evaluation; Female; Fe | 1992 |
Ibuprofen safety.
Topics: Aspirin; Child; Fever; Humans; Ibuprofen; Reye Syndrome | 1992 |
Single-dose pharmacokinetics of ibuprofen and acetaminophen in febrile children.
Topics: Acetaminophen; Child; Child, Preschool; Dose-Response Relationship, Drug; Drug Administration Schedu | 1992 |
Management of childhood fever.
Topics: Acetaminophen; Child; Fever; Humans; Ibuprofen | 1991 |
Management of childhood fever.
Topics: Acetaminophen; Aspirin; Child; Fever; Humans; Ibuprofen | 1991 |
Ibuprofin safety.
Topics: Child; Fever; Humans; Ibuprofen; United Kingdom; United States; United States Food and Drug Administ | 1992 |
Junifen suspension--ibuprofen for febrile children.
Topics: Administration, Oral; Child; Child, Preschool; Fever; Humans; Ibuprofen; Infant; Suspensions | 1991 |
Ibuprofen for fever.
Topics: Child, Preschool; Fever; Humans; Ibuprofen; Infant | 1991 |
A case of severe pancytopenia caused by ibuprofen.
Topics: Aged; Fever; Hematemesis; Humans; Ibuprofen; Male; Pancytopenia; Time Factors | 1991 |
Pharmacokinetics of ibuprofen in febrile children.
Topics: Administration, Oral; Child; Child, Preschool; Chromatography, High Pressure Liquid; Fever; Half-Lif | 1991 |
Paediatric ibuprofen--an overview.
Topics: Child; Child, Preschool; Consumer Product Safety; Fever; Humans; Ibuprofen; Infant | 1990 |
Acquired Brown's syndrome in systemic lupus erythematosus: another ocular manifestation.
Topics: Adult; Diclofenac; Diplopia; Fever; Humans; Hydroxychloroquine; Ibuprofen; Lupus Erythematosus, Syst | 1990 |
Hepatic granulomata. Presenting with prolonged fever. Resolution with anti-inflammatory treatment.
Topics: Child; Diagnosis, Differential; Female; Fever; Granuloma; Granulomatous Disease, Chronic; Humans; Ib | 1990 |
Antipyretic effect of central alpha-MSH summates with that of acetaminophen or ibuprofen.
Topics: Acetaminophen; alpha-MSH; Animals; Anti-Inflammatory Agents, Non-Steroidal; Drug Combinations; Femal | 1989 |
Ibuprofen vs acetaminophen in children.
Topics: Acetaminophen; Child; Drug Overdose; Fever; Humans; Ibuprofen; Pain; Suspensions | 1989 |
Macrophage inflammatory protein-1: a prostaglandin-independent endogenous pyrogen.
Topics: Animals; Chemotactic Factors; Dinoprostone; Female; Fever; Heparin; Humans; Ibuprofen; Interleukin-1 | 1989 |
Ibuprofen: an alternative for children's fevers.
Topics: Acetaminophen; Child; Child, Preschool; Fever; Humans; Ibuprofen | 1989 |
Fever. What to do and what not to do.
Topics: Acetaminophen; Acute-Phase Reaction; Aspirin; Body Temperature Regulation; Cold Temperature; Fever; | 1988 |
Severe generalized reactions to ibuprofen: report of a case.
Topics: Diagnosis, Differential; Disseminated Intravascular Coagulation; Female; Fever; Humans; Hypotension; | 1986 |
Ibuprofen prevents Pasteurella hemolytica endotoxin-induced changes in plasma prostanoids and serotonin, and fever in sheep.
Topics: 6-Ketoprostaglandin F1 alpha; Animals; Dinoprost; Endotoxins; Female; Fever; Ibuprofen; Pasteurella; | 1985 |
Fever: to treat or not to treat.
Topics: Acetaminophen; Aspirin; Child; Fever; Humans; Ibuprofen; Interleukin-1; Reye Syndrome | 1985 |