acetaminophen and Teeth, Impacted studies

Acetaminophen: Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
paracetamol : A member of the class of phenols that is 4-aminophenol in which one of the hydrogens attached to the amino group has been replaced by an acetyl group.

Research Excerpts

Excerpt	Relevance	Reference
"To evaluate the prevention of opioid-induced nausea and vomiting (OINV) and the relief of moderate to severe acute pain by CL-108, a novel drug combining a low-dose antiemetic (rapid-release promethazine 12."	9.30	Prevention of Opioid-Induced Nausea and Vomiting During Treatment of Moderate to Severe Acute Pain: A Randomized Placebo-Controlled Trial Comparing CL-108 (Hydrocodone 7.5 mg/Acetaminophen 325 mg/Rapid-Release, Low-Dose Promethazine 12.5 mg) with Conventi ( Chou, JC; Daniels, SE; Giannakopoulos, HE; Granquist, EJ; Levin, LM; Maibach, H; Muse, DD; Oreadi, D; Papas, AS; Patrick, K; Schachtel, BP; Zuniga, JR, 2019)
"The aim of the present study was to investigate the analgesic and anti-inflammatory effects of dexketoprofen trometamol (DT) and paracetamol on deep acute somatic pain and inflammation in patients undergoing impacted third molar surgery."	9.19	Effect of low-dose dexketoprofen trometamol and paracetamol on postoperative complications after impacted third molar surgery on healthy volunteers: A pilot study. ( Durmus, E; Eroglu, CN; Kiresi, D, 2014)
"To evaluate the prevention of opioid-induced nausea and vomiting (OINV) and the relief of moderate to severe acute pain by CL-108, a novel drug combining a low-dose antiemetic (rapid-release promethazine 12."	5.30	Prevention of Opioid-Induced Nausea and Vomiting During Treatment of Moderate to Severe Acute Pain: A Randomized Placebo-Controlled Trial Comparing CL-108 (Hydrocodone 7.5 mg/Acetaminophen 325 mg/Rapid-Release, Low-Dose Promethazine 12.5 mg) with Conventi ( Chou, JC; Daniels, SE; Giannakopoulos, HE; Granquist, EJ; Levin, LM; Maibach, H; Muse, DD; Oreadi, D; Papas, AS; Patrick, K; Schachtel, BP; Zuniga, JR, 2019)
"The aim of the present study was to investigate the analgesic and anti-inflammatory effects of dexketoprofen trometamol (DT) and paracetamol on deep acute somatic pain and inflammation in patients undergoing impacted third molar surgery."	5.19	Effect of low-dose dexketoprofen trometamol and paracetamol on postoperative complications after impacted third molar surgery on healthy volunteers: A pilot study. ( Durmus, E; Eroglu, CN; Kiresi, D, 2014)
"This double-blind, randomized controlled study evaluated etoricoxib (90 and 120 mg), ibuprofen (600 mg), and acetaminophen (600 mg/codeine) (60 mg, (A/C)) in patients aged ≥ 18 years with moderate or severe pain after surgical extraction of ≥ 2 third molars (≥ 1 impacted)."	5.15	Evaluation of the dose range of etoricoxib in an acute pain setting using the postoperative dental pain model. ( Bandy, DP; Boice, J; Christensen, SE; Daniels, SE; Liu, H; Losada, MC; Mehta, A; Peloso, PM, 2011)
"To compare the analgesic effect of single doses of etoricoxib 120 mg, oxycodone/ acetaminophen 10 mg/650 mg and codeine/ acetaminophen 60 mg/600 mg in acute pain using the dental impaction model."	5.11	The analgesic effect of etoricoxib relative to that of cetaminophen analgesics: a randomized, controlled single-dose study in acute dental impaction pain. ( Ang, J; Fricke, JR; Malmstrom, K; Reicin, A; Shingo, S, 2005)
"The patients' postoperative pain scores at 4 and 24 hours were collected via a verbal rating scale by the primary investigator."	2.87	Use of Intravenous Acetaminophen in Postoperative Pain Management After Partial and Full Bony Impacted Third Molar Extractions: A Randomized Double-Blind Controlled Trial. ( Atencio, I; Baur, DA; Beushausen, M; Fino, NF; Flores-Hidalgo, A; Kowalczyk, JJ, 2018)
"Acute pain is a significant burden to the individual and to society."	2.87	Analgesic Efficacy of an Acetaminophen/Ibuprofen Fixed-dose Combination in Moderate to Severe Postoperative Dental Pain: A Randomized, Double-blind, Parallel-group, Placebo-controlled Trial. ( Atkinson, HC; Daniels, SE; Frampton, C; Stanescu, I, 2018)
"Postoperative pain was assessed using the visual analog scale (VAS) every 3 hours (while awake) for the first 48 hours after surgery."	2.84	Efficacy of Codeine When Added to Paracetamol (Acetaminophen) and Ibuprofen for Relief of Postoperative Pain After Surgical Removal of Impacted Third Molars: A Double-Blinded Randomized Control Trial. ( Best, AD; Cameron, CM; De Silva, HL; De Silva, RK; Thomson, WM; Tong, DC, 2017)
"The difference in postoperative pain was assessed by four primary points: pain intensity as measured by a 10 mm visual analogue scale hourly for 12 h, median time to rescue analgesics, number of analgesics consumed and patient's overall 5-point global assessment scale."	2.79	Comparative study of intravenous Tramadol versus Ketorolac for preventing postoperative pain after third molar surgery--a prospective randomized study. ( Gopalraju, P; Lalitha, RM; Prasad, K; Ranganath, K, 2014)
"We sought to investigate the dose-response efficacy and speed of onset of pain relief of a fast-dissolving APAP formulation compared with lower doses of APAP and placebo in dental patients after impacted third molar extraction."	2.78	Efficacy and speed of onset of pain relief of fast-dissolving paracetamol on postsurgical dental pain: two randomized, single-dose, double-blind, placebo-controlled clinical studies. ( Brown, J; Buchanan, WL; Collaku, A; Cooper, SA; Otto, J; Reed, K; Yue, Y, 2013)
"Dexamethasone also reduced postoperative pain after LITM surgical extraction significantly on postoperative days 2 and 7."	2.77	Effect of single dose preoperative intramuscular dexamethasone injection on lower impacted third molar surgery. ( Boonsiriseth, K; Kaewpradub, P; Klongnoi, B; Wongsirichat, N, 2012)
"Postoperative pain was assessed with a visual analogue scale at 4, 6, 12, 24, and 48 h postoperatively (p."	2.77	Comparative study of tramadol combined with dexamethasone and diclofenac sodium in third-molar surgery. ( Brandão, JR; da Silva, LC; de Assunção Oliveira, AC; de Santana Santos, T; de Sousa Santos, JA; Menezes Júnior, LR, 2012)
"and group L 8 mg lornoxicam i."	2.76	Postoperative analgesia in impacted third molar surgery: the role of preoperative diclofenac sodium, paracetamol and lornoxicam. ( Alanoglu, Z; Demiralp, S; Ozturk, A; Tuzuner Oncul, AM; Ucok, C; Yazicioglu, D, 2011)
"The authors assessed the participants' postoperative pain by means of a visual analog scale at four, six, eight, 12, 24 and 48 hours."	2.76	Evaluation of the muscle relaxant cyclobenzaprine after third-molar extraction. ( Calazans, AC; de Oliveira E Silva, ED; de Santana Santos, T; Gomes, AC; Martins-Filho, PR; Silva, LC, 2011)
"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)
" AEs were assessed at 8 hours after dosing in stage 1, at 72 hours after dosing in stage 2, and at the follow-up visit (7-10 days after surgery); in addition, patients were instructed to report any AE that occurred between scheduled assessments."	2.75	A single-tablet fixed-dose combination of racemic ibuprofen/paracetamol in the management of moderate to severe postoperative dental pain in adult and adolescent patients: a multicenter, two-stage, randomized, double-blind, parallel-group, placebo-control ( Aspley, S; Christensen, KS; Daniels, SE; Mehlisch, DR; Southerden, KA, 2010)
" Mild-to-moderate adverse effects were reported."	2.74	A randomized, double-blind, placebo-controlled study comparing the efficacy and safety of paracetamol, serratiopeptidase, ibuprofen and betamethasone using the dental impaction pain model. ( Chopra, D; Kakkar, AK; Mehra, P; Rehan, HS, 2009)
"On the second postoperative day, facial edema showed a statistically significant reduction in both dexamethasone 4-mg and dexamethasone 8-mg groups compared with the control group, but no statistically significant differences were observed between the 2 dosage regimens of dexamethasone."	2.73	Effect of submucosal injection of dexamethasone on postoperative discomfort after third molar surgery: a prospective study. ( Beretta, M; Borgonovo, A; Farronato, D; Garramone, RA; Grossi, GB; Maiorana, C; Santoro, F, 2007)
"5 mg) vs paracetamol (500 mg) and placebo given in a flexible dosage regimen to treat pain resulting from extraction of impacted third molar teeth."	2.71	Analgesic efficacy of low-dose diclofenac versus paracetamol and placebo in postoperative dental pain. ( Gold, MS; Ionescu, E; Kubitzek, F; Liu, JM; Ziegler, G, 2003)
"Trismus was determined by measuring maximum interincisal opening and facial swelling was evaluated using a tape measuring method."	2.71	Comparison of the effects of 2 doses of methylprednisolone on pain, swelling, and trismus after third molar surgery. ( Erdogan, O; Esen, E; Karsli, ED; UStün, Y, 2003)
"The difference in postoperative pain was assessed by four primary end-points: pain intensity as measured by a 100-mm visual analogue scale hourly for 12 h, median time to rescue analgesic, postoperative acetaminophen consumption, and patient's global assessment."	2.71	Preoperative intravenous tramadol versus ketorolac for preventing postoperative pain after third molar surgery. ( Ong, KS; Tan, JM, 2004)
" However, it should be noted that there is a difference in the bioavailability between the 2 formulations of up to 30%, which may explain the findings."	2.71	The analgesic efficacy of intravenous versus oral tramadol for preventing postoperative pain after third molar surgery. ( Lirk, P; Ong, CK; Sow, BW; Tan, JM, 2005)
" There were no significant differences between treatment groups with respect to the number of patients requiring rescue medication, however the time to dosing was significantly longer for those taking soluble aspirin when compared with placebo (hazard ratio 2."	2.71	An investigation into the comparative efficacy of soluble aspirin and solid paracetamol in postoperative pain after third molar surgery. ( Hawkesford, JE; Hill, CM; Seymour, RA; Stillings, M; Sykes, J, 2003)
"Valdecoxib has a tolerability profile superior to that of oxycodone/acetaminophen."	2.70	The analgesic efficacy of valdecoxib vs. oxycodone/acetaminophen after oral surgery. ( Daniels, SE; Desjardins, PJ; Recker, DP; Talwalker, S; Verburg, KM, 2002)
" There were no serious adverse events observed in this study, with the overall incidence of side effects being somewhat less in the (R)- ketoprofen groups than in the acetaminophen 1,000 mg group."	2.69	Analgesic efficacy and safety of (R)- ketoprofen in postoperative dental pain. ( Cooper, SA; Hersh, EV; Reynolds, B; Reynolds, DC, 1998)
"Ibuprofen liquigel is a solubilized potassium ibuprofen 200-mg gelatin capsule formulation that was approved for over-the-counter use in 1995."	2.69	Ibuprofen liquigel for oral surgery pain. ( Cooper, SA; Doyle, G; Hersh, EV; Hong, D; Levin, LM; Secreto, SA; Waksman, J; Wedell, D, 2000)
"Two-hundred six outpatients with postoperative pain after the surgical removal of impacted third molars were randomly assigned on a double-blind basis to receive oral doses of ketorolac tromethamine 10 and 20 mg, ibuprofen 400 mg, acetaminophen 600 mg, a combination of acetaminophen 600 mg plus codeine 60 mg, or placebo."	2.67	Evaluation of ketorolac, ibuprofen, acetaminophen, and an acetaminophen-codeine combination in postoperative oral surgery pain. ( Beaver, WT; Forbes, JA; Grodin, CD; Kehm, CJ, 1990)
" Patients treated with benorylate 4 g reported significantly less pain between 3-6 h after dosage than those treated with placebo."	2.66	The efficacy of benorylate in postoperative dental pain. ( Moore, U; Nicholson, E; Rawlins, MD; Seymour, RA; Williams, FM, 1989)
"Acetaminophen was no better than placebo."	2.66	Effect of pretreatment with acetaminophen-propoxyphene for oral surgery pain. ( Desjardins, PJ; Liashek, P; Triplett, RG, 1987)
"Suprofen was better than cosalgesic in the patients' opinion of initial (p = 0."	2.66	Suprofen compared to dextropropoxyphene hydrochloride and paracetamol (Cosalgesic) after extraction of wisdom teeth under general anaesthesia. ( Absi, EG; Rosen, M; Webster, JA, 1985)
" A statiscally significant dose-response relationship was obtained between the supplementary doses of codeine and analgesic efficacy."	2.65	Paracetamol plus supplementary doses of codeine. An analgesic study of repeated doses. ( Ahlström, U; Bångens, S; Hellem, S; Johansson, G; Jönsson, E; Nordh, PG; Persson, G; Quiding, H, 1982)
"Pain, swelling and trismus were the commonest complaints."	1.31	Postoperative complaints following impacted mandibular third molar surgery in Ile-Ife, Nigeria. ( Assam, E; Oginni, FO; Ogunbodede, EO; Ugboko, VI, 2002)
" However, pain intensity scores indicate that APAP double dose gave less analgesia toward the end of the dosing interval than the standard regimen."	1.28	Effects of acetaminophen after bilateral oral surgery: double dose twice daily versus standard dose four times daily. ( Pettersen, N; Skoglund, LA, 1991)
"Ibuprofen 400 mg was consistently more effective than aspirin 650 mg, acetaminophen 600 mg, and both aspirin and acetaminophen when combined with codeine 60 mg."	1.27	Five studies on ibuprofen for postsurgical dental pain. ( Cooper, SA, 1984)
"Swelling, pain and trismus were evaluated quantitatively after the removal of impacted mandibular third molars on 30 healthy individuals."	1.27	Interrelation of complaints after removal of impacted mandibular third molars. ( Pedersen, A, 1985)

Research

Studies (89)

Authors

Clinical Trials (20)

Trial Overview

Trial Outcomes

Amount of Rescue Medication

Timeframe	Studies, this research(%)	All Research%
pre-1990	16 (17.98)	18.7374
1990's	20 (22.47)	18.2507
2000's	24 (26.97)	29.6817
2010's	27 (30.34)	24.3611
2020's	2 (2.25)	2.80

Authors	Studies
Cooper, SA	10
Desjardins, PJ	6
Bertoch, T	1
Paredes-Diaz, A	1
Troullos, E	1
Tajaddini, A	1
Centofanti, R	1
An, R	1
Morella, D	1
Furtado de Carvalho, M	1
Slusarenko da Silva, Y	1
Reher, P	1
Naclério-Homem, MDG	1
Best, AD	1
De Silva, RK	1
Thomson, WM	1
Tong, DC	1
Cameron, CM	1
De Silva, HL	1
Atencio, I	1
Beushausen, M	1
Kowalczyk, JJ	1
Flores-Hidalgo, A	1
Fino, NF	1
Baur, DA	1
Moore, PA	1
Dionne, RA	3
Hersch, EV	1
Daniels, SE	7
Atkinson, HC	1
Stanescu, I	1
Frampton, C	1
Zuniga, JR	1
Papas, AS	1
Patrick, K	1
Muse, DD	1
Oreadi, D	1
Giannakopoulos, HE	1
Granquist, EJ	1
Levin, LM	2
Chou, JC	1
Maibach, H	1
Schachtel, BP	2
Laskin, DM	1
Yue, Y	1
Collaku, A	1
Brown, J	1
Buchanan, WL	1
Reed, K	1
Otto, J	1
Gopalraju, P	1
Lalitha, RM	1
Prasad, K	1
Ranganath, K	1
Catherine, B	1
Rood, JP	3
Marianetti, TM	1
Torroni, A	1
Gasparini, G	1
Moro, AS	1
Pelo, S	1
Eroglu, CN	2
Durmus, E	1
Kiresi, D	2
Freudenthal, N	1
Sternudd, M	1
Jansson, L	1
Wannfors, K	1
Ataoglu, H	1
Yildirim, G	1
Voelker, M	1
Gatoulis, SC	1
Chopra, D	1
Rehan, HS	1
Mehra, P	1
Kakkar, AK	1
Daniels, S	1
Reader, S	1
Berry, P	1
Goulder, M	1
Akural, EI	1
Järvimäki, V	1
Länsineva, A	1
Niinimaa, A	1
Alahuhta, S	1
Borel, JF	1
Deschaumes, C	1
Devoize, L	1
Huard, C	1
Orliaguet, T	1
Dubray, C	1
Baudet-Pommel, M	1
Dallel, R	1
Siddiqi, A	1
Morkel, JA	1
Zafar, S	1
Mehlisch, DR	2
Aspley, S	2
Southerden, KA	1
Christensen, KS	1
Bandy, DP	2
Christensen, SE	1
Boice, J	1
Losada, MC	1
Liu, H	1
Mehta, A	1
Peloso, PM	1
Tuzuner Oncul, AM	1
Yazicioglu, D	1
Alanoglu, Z	1
Demiralp, S	1
Ozturk, A	1
Ucok, C	1
Cheung, CW	1
Choi, WS	1
Leung, YY	1
Lui, F	1
Ng, JK	1
Hei-Ho, AM	1
Irwin, MG	1
de Santana Santos, T	3
Calazans, AC	1
Martins-Filho, PR	1
Silva, LC	1
de Oliveira E Silva, ED	2
Gomes, AC	1
Klongnoi, B	1
Kaewpradub, P	1
Boonsiriseth, K	1
Wongsirichat, N	1
de Sousa Santos, JA	1
da Silva, LC	1
Menezes Júnior, LR	1
de Assunção Oliveira, AC	1
Brandão, JR	1
da Costa Araújo, FA	1
de Morais, HH	1
Laureano Filho, JR	1
Vasconcellos, RJ	1
Qi, DS	1
May, LG	1
Zimmerman, B	1
Peng, P	1
Atillasoy, E	1
Brown, JD	1
Macleod, AG	1
Ashford, B	1
Voltz, M	1
Williams, B	1
Cramond, T	1
Gorta, L	1
Simpson, JM	1
Oginni, FO	1
Ugboko, VI	1
Assam, E	1
Ogunbodede, EO	1
Comfort, MB	1
Tse, AS	1
Tsang, AC	1
McGrath, C	1
Seymour, RA	2
Hawkesford, JE	1
Sykes, J	1
Stillings, M	1
Hill, CM	1
Bjørnsson, GA	1
Haanaes, HR	1
Skoglund, LA	4
Kubitzek, F	1
Ziegler, G	1
Gold, MS	1
Liu, JM	1
Ionescu, E	1
UStün, Y	1
Erdogan, O	1
Esen, E	1
Karsli, ED	1
Joshi, A	1
Parara, E	1
Macfarlane, TV	1
Ong, KS	1
Tan, JM	2
Moller, PL	1
Sindet-Pedersen, S	1
Petersen, CT	1
Juhl, GI	1
Dillenschneider, A	1
Malmstrom, K	1
Ang, J	1
Fricke, JR	1
Shingo, S	1
Reicin, A	1
Ong, CK	1
Lirk, P	1
Sow, BW	1
Pozos-Guillén, Ade J	1
Martínez-Rider, R	1
Aguirre-Bañuelos, P	1
Arellano-Guerrero, A	1
Hoyo-Vadillo, C	1
Pérez-Urizar, J	1
Black, PM	1
Bird, SR	1
Petruschke, RA	1
Chang, DJ	1
Smugar, SS	1
Tershakovec, AM	1
Grossi, GB	1
Maiorana, C	1
Garramone, RA	1
Borgonovo, A	1
Beretta, M	1
Farronato, D	1
Santoro, F	1
Gordon, SM	1
Chuang, BP	1
Wang, XM	1
Hamza, MA	1
Rowan, JS	1
Brahim, JS	1
Al-Khateeb, TH	1
Nusair, Y	1
Quiding, H	4
Oksala, E	1
Happonen, RP	1
Lehtimäki, K	1
Ojala, T	1
Persson, G	1
Ahlström, U	2
Bångens, S	1
Hellem, S	1
Johansson, G	1
Jönsson, E	1
Nordh, PG	1
Irvine, GH	1
Lutterloch, MJ	1
Bowerman, JE	1
Løkken, P	1
Skjelbred, P	2
Gómez-Jiménez, J	1
Franco-Patino, R	1
Chargoy-Vera, J	1
Olivares-Sosa, R	1
Urquhart, E	1
Snyder, J	1
Hargreaves, KM	1
Walton, GM	1
Snowdon, AT	1
Rickwood, D	1
Sandhu, S	1
Collins, M	1
Young, I	1
Sweeney, P	1
Fenn, GC	1
Stratford, ME	1
Wilson, A	1
Harris, M	1
Berge, TI	1
Lownie, JF	1
Lownie, MA	1
Reinach, SG	1
Reynolds, DC	1
Reynolds, B	1
Hersh, EV	2
Sençift, K	1
Kir, S	1
Tuncer, M	1
Breivik, EK	1
Björnsson, GA	1
Ziccardi, VB	1
Daly-DeJoy, E	1
Seng, GF	1
Doyle, G	1
Waksman, J	1
Wedell, D	1
Hong, D	1
Secreto, SA	1
Bulut, E	1
Bulut, S	1
Etikan, I	1
Koseoglu, O	1
Talwalker, S	1
Recker, DP	1
Verburg, KM	1
Sveen, K	1
Gilhuus-Moe, O	1
Cheung, LK	1
Rodrigo, C	1
Fyllingen, G	1
Pettersen, N	1
Murtagh, J	1
Lecointre, C	1
Ragot, JP	1
Lyall, JB	1
Forbes, JA	2
Butterworth, GA	1
Burchfield, WH	1
Beaver, WT	2
Kehm, CJ	1
Grodin, CD	1
Habib, S	1
Matthews, RW	1
Scully, C	1
Levers, BG	1
Shepherd, JP	1
Moore, U	1
Williams, FM	1
Nicholson, E	1
Rawlins, MD	1
Nyström, E	1
Gustafsson, I	1
Chapman, PJ	1
Firestein, A	1
Cohn, P	1
Liashek, P	1
Triplett, RG	1
Markowitz, NR	1
Young, SK	1
Rohrer, MD	1
Turner, JL	1
Fåhraeus, J	1
Ström, C	1
Rosen, M	1
Absi, EG	1
Webster, JA	1
Pedersen, A	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Hydrocodone/Acetaminophen Tablets in Postsurgical Dental Pain[NCT04307940]	Phase 4	221 participants (Actual)	Interventional	2020-03-12	Completed
Maxigesic 325 Acute Dental Pain Study: A Double-blind, Placebo-controlled, Randomized, Parallel Group Comparison of the Effects of Maxigesic 325 Versus Acetaminophen, Ibuprofen and Placebo in Participants With Acute Dental Pain[NCT01420653]	Phase 3	408 participants (Actual)	Interventional	2013-04-30	Completed
A Study to Compare the Analgesic Efficacy of Two Different Paracetamol Doses as Measured by Post-operative Dental Pain Relief[NCT01082081]	Phase 4	300 participants (Actual)	Interventional	2009-10-31	Completed
A Study to Compare the Analgesic Efficacy of Two Different Paracetamol Doses as Measured by Post-operative Pain Relief[NCT01075243]	Phase 4	401 participants (Actual)	Interventional	2009-11-30	Completed
Onset of Action of a Fast Release Aspirin Tablet and Acetaminophen Caplet in Sore Throat Pain[NCT01453400]	Phase 3	177 participants (Actual)	Interventional	2011-09-27	Completed
Comparative Onset of Action of a Fast Release Aspirin Tablet in a Dental Impaction Pain Model[NCT01420094]	Phase 3	510 participants (Actual)	Interventional	2011-06-16	Completed
Analgesic Efficacy of Preoperative Oral Administration of Dexketoprofen Trometamol in Third Molar Surgery, Compared to Postoperative Administration[NCT02380001]	Phase 4	60 participants (Actual)	Interventional	2015-01-31	Completed
A Full-Factorial, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Dose Efficacy and Safety Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen, and Naproxen Sodium in Postoperative Dental Pain[NCT05761574]	Phase 3	440 participants (Anticipated)	Interventional	2023-05-22	Recruiting
An Open-label, Single-dose, Pharmacokinetic Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Orthodontic Pain[NCT05844995]	Phase 1	30 participants (Anticipated)	Interventional	2023-09-13	Recruiting
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Safety and Efficacy Study of Acetaminophen 1000 mg and Acetaminophen 650 mg in Post Operative Dental Pain[NCT01115673]	Phase 3	540 participants (Actual)	Interventional	2010-06-30	Completed
IV vs. Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty: a Randomized, Blinded Trial[NCT03020966]	Phase 4	154 participants (Actual)	Interventional	2017-02-16	Completed
Assessment of the Operative Course in Connection With Removal of Lower Third Molars With Particular Consideration to the Occurence of Pain and Swelling[NCT00805298]		154 participants (Actual)	Interventional	2008-08-31	Completed
Evaluation of the Effectiveness of the Use of the Therapeutic Bandage Method in Third Molar Surgery. Splint-mouth Randomized Blind Controlled Clinical Trial[NCT03393533]		7 participants (Actual)	Interventional	2017-10-20	Completed
Topical Hydrocortisone for Pain and Edema Control After Third Molar Surgery: a Clinical, Crossover, Randomized, Double-blind, Controlled Study[NCT03179813]	Phase 4	40 participants (Anticipated)	Interventional	2017-05-01	Completed
Oral Versus Intravenous Acetaminophen for Postoperative Pain Management After Oocyte Retrieval Procedure. A Double Blinded, Placebo Controlled, Randomized Clinical Trial[NCT04662567]		42 participants (Actual)	Interventional	2021-03-12	Terminated (stopped due to It was determined that the study should not continue as the study drug, Acetaminophen, could only be mixed in a solvent that would not allow the patients to be NPO prior to procedure.)
Comparative Efficacy of Intravenous Acetaminophen vs. Oral Acetaminophen in Ambulatory Surgery[NCT03558555]	Phase 4	103 participants (Actual)	Interventional	2017-12-08	Completed
A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study to Evaluate the Efficacy of Rofecoxib and a Dosing Regimen of Oxycodone With Acetaminophen Over 24 Hours in Patients With Postoperative Dental Pain[NCT00092326]	Phase 3	269 participants (Actual)	Interventional	2002-06-30	Completed
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)
Towards Predicting the Analgesic Response to Ibuprofen Following Third-molar Extraction[NCT03893175]	Phase 1	86 participants (Actual)	Interventional	2019-05-10	Completed
Analgesic Effect of Ibuprofen 400 mg/Paracetamol 1000 mg, Ibuprofen 400 mg/ Paracetamol 1000 mg/60 mg Codeine, and Paracetamol 1000 mg/Codeine 60 mg: A Single-dose, Randomized, Placebo-controlled and Double-blind Study[NCT00921700]	Phase 4	200 participants (Actual)	Interventional	2009-06-30	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

"To quantify the use of opioid analgesics in treatment of post-operative dental pain, the amount of rescue medications (opioids) was converted to a standard unit, which was Morphine Milligram Equivalent (MME) using below formula:~MME/Day = Strength per Unit × (Number of units / Days supply) × MME conversion factor" (NCT04307940)
Timeframe: Up to 12 hours postdose

Duration of Pain at Least Half Gone Over 12 Hours

Duration of Pain at Least Half Gone Over 6 Hours

Sum of Pain Intensity Difference Over 12 Hours (SPID 0-12)

Intervention	Morphine Milligram Equivalent (MME) (Mean)
Naproxen Sodium	7.8
Hydrocodone / APAP	9.3
Placebo	10.5

Intervention	Hours (Least Squares Mean)
Naproxen Sodium	8.87
Hydrocodone / APAP	6.57
Placebo	3.31

Intervention	Hours (Least Squares Mean)
Naproxen Sodium	4.60
Hydrocodone / APAP	4.08
Placebo	1.49

Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. Sum of Pain Intensity Differences (SPIDs) was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 12 hours ranges from -120 to 120. A higher value indicates a better pain reduction. (NCT04307940)
Timeframe: Up to 12 hours postdose

Sum of Pain Intensity Difference Over 6 Hours (SPID 0-6)

Intervention	Scores on a scale*hours (Least Squares Mean)
Naproxen Sodium	53.20
Hydrocodone / APAP	38.39
Placebo	13.57

Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. Sum of Pain Intensity Differences (SPIDs) was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 6 hours ranges from -60 to 60. A higher value indicates a better pain reduction. (NCT04307940)
Timeframe: Up to 6 hours postdose

Time to First Use of Rescue Medication

Intervention	Scores on a scale*hours (Least Squares Mean)
Naproxen Sodium	28.41
Hydrocodone / APAP	24.35
Placebo	6.23

If a subject did not take the rescue medication during the treatment period, (s)he was censored at the time of last assessment. (NCT04307940)
Timeframe: Up to 12 hours postdose

Total Pain Relief Over 12 Hours (TOTPAR 0-12)

Intervention	Hours (Median)
Naproxen Sodium	NA
Hydrocodone / APAP	10.42
Placebo	2.57

Pain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief). Total Pain Relief is calculated as the area under the curve of pain relief score over time for the given time period by multiplying the pain relief score at each time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. TOTPAR over 12 hours ranges from 0 to 48, a higher value indicates more pain relief. (NCT04307940)
Timeframe: Up to 12 hours postdose

Total Pain Relief Over 6 Hours (TOTPAR 0-6)

Intervention	Scores on a scale*hours (Least Squares Mean)
Naproxen Sodium	28.41
Hydrocodone / APAP	21.31
Placebo	10.63

Pain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief). Total Pain Relief is calculated as the area under the curve of pain relief score over time for the given time period by multiplying the pain relief score at each time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. TOTPAR over 6 hours ranges from 0 to 24, a higher value indicates more pain relief. (NCT04307940)
Timeframe: Up to 6 hours postdose

Number of Participants Required or Did Not Reqiure Rescue Pain Medication

SPID (Summed Pain Intensity Differences)

Intervention	Scores on a scale*hours (Least Squares Mean)
Naproxen Sodium	14.53
Hydrocodone / APAP	12.69
Placebo	5.14

Intervention	Participants (Count of Participants)
	Number of participants required rescue pain medication	Number of participants did not require any rescue pain medication
Hydrocodone / APAP	43	40
Naproxen Sodium	18	68
Placebo	29	14

"The time-adjusted Summed Pain Intensity Differences (SPIDs) of the VAS pain intensity scores up to 48 hours after the first dose of study medication.~This was calculated from the visual analogue scale (VAS) pain intensity scores recorded during the 48 hours double blind treatment period, with the last measure taken just prior to the final dose of blinded study medication. The visual analogue scale is 100mm long with 0= no pain and 100=worst pain imaginable. The Visual Analogue Scale It is expected that treatments which can provide superior analgesic effect will demonstrate a greater Summed Pain Intensity Difference." (NCT01420653)
Timeframe: 48 hours afte the first dose

Participants Global Assessment to Response to Treatment (PGART)

Intervention	score on a scale (Mean)
Maxigesic 325	31.56
Acetaminophen	17.71
Ibuprofen	23.18
Placebo	14.86

PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent. (NCT01082081)
Timeframe: Baseline to 6 hours post dose

Percentage of Participants Who Took Rescue Medication During 2 to 6 Hours

Intervention	Units on a scale (Mean)
Paracetamol Caplet 1000 mg	1.54
Paracetamol Caplet 500 mg	1.24
Placebo Caplet	0.63

Percentage of participants who took rescue medication during 2 to 6 hours (NCT01082081)
Timeframe: Within 2 to 6 hours post dose

Percentage of Participants Who Took Rescue Medication Within 2 Hours

Intervention	Percentage of participants (Number)
Paracetamol Caplet 1000 mg	57.9
Paracetamol Caplet 500 mg	55.5
Placebo Caplet	53.3

Percentage of participants who received rescue medication within 2 hours (NCT01082081)
Timeframe: Baseline to 2 hours post dose

SPID Scores at 4 Hours

Intervention	Percentage of participants (Number)
Paracetamol Caplet 1000 mg	5.00
Paracetamol Caplet 500 mg	11.80
Placebo Caplet	18.30

"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline." (NCT01082081)
Timeframe: Every two hours from baseline to 4 hours post dose

SPID Scores at 6 Hours

Intervention	Units on a scale (Mean)
Paracetamol Caplet 1000 mg	2.0
Paracetamol Caplet 500 mg	0.7
Placebo Caplet	-0.5

"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline." (NCT01082081)
Timeframe: Every two hours from baseline to 6 hours post dose

SPRID at 2 Hours

Intervention	Units on a scale (Mean)
Paracetamol Caplet 1000 mg	2.6
Paracetamol Caplet 500 mg	0.7
Placebo Caplet	-0.8

SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -1.8 (least pain relief) to 12.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief] (NCT01082081)
Timeframe: Every two hours from baseline to 2 hours post dose

SPRID at 4 Hours

Intervention	Units on a scale (Mean)
Paracetamol Caplet 1000 mg	4.62
Paracetamol Caplet 500 mg	3.26
Placebo Caplet	1.49

SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -3.8 (least pain relief) to 26.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief] (NCT01082081)
Timeframe: Every two hours from baseline to 4 hours post dose

Sum of Pain Intensity Difference (SPID) Scores at 2 Hours

Intervention	Units on a scale (Mean)
Paracetamol Caplet 1000 mg	7.82
Paracetamol Caplet 500 mg	4.42
Placebo Caplet	2.07

"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline." (NCT01082081)
Timeframe: Every two hours from baseline to 2 hours post dose

Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)

Intervention	Units on a scale (Mean)
Paracetamol Caplet 1000 mg	1.3
Paracetamol Caplet 500 mg	0.8
Placebo Caplet	0.0

SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief] (NCT01082081)
Timeframe: Every two hours from baseline to 6 hours post dose

Time to Confirmed First Perceptible Pain Relief

Intervention	Units on a scale (Mean)
Paracetamol Caplet 1000 mg	10.60
Paracetamol Caplet 500 mg	5.87
Placebo Caplet	3.35

Participants recorded the time to first perceptible relief by starting the first stopwatch at the time of dosing and stopping it when he/she experienced the first perceptible pain relief. The first perceptible pain relief was confirmed if the participant also stopped the second stopwatch indicating meaningful relief. (NCT01082081)
Timeframe: Baseline to 6 hours post dose

Time to Onset of Meaningful Pain Relief

Intervention	minutes (Mean)
Paracetamol Caplet 1000 mg	80.63
Paracetamol Caplet 500 mg	119.10
Placebo Caplet	189.53

Participants evaluated the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief. (NCT01082081)
Timeframe: Baseline to 6 hours post dose

Time to Start Using Rescue Medication

Intervention	minutes (Mean)
Paracetamol Caplet 1000 mg	96.44
Paracetamol Caplet 500 mg	129.75
Placebo Caplet	207.67

Median time of use of rescue medication by participants was calculated. (NCT01082081)
Timeframe: Baseline to 6 hours post dose

Total Pain Relief (TOTPAR) at 2 Hours

Intervention	minutes (Median)
Paracetamol Caplet 1000 mg	242.00
Paracetamol Caplet 500 mg	189.00
Placebo Caplet	148.00

"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet - timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]." (NCT01082081)
Timeframe: Every two hours from baseline to 2 hours post dose

TOTPAR at 4 Hours

Intervention	Units on a scale (Mean)
Paracetamol Caplet 1000 mg	3.33
Paracetamol Caplet 500 mg	2.46
Placebo Caplet	1.47

"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet - timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]." (NCT01082081)
Timeframe: Every two hours from baseline to 4 hours post dose

TOTPAR at 6 Hours

Intervention	Units on a scale (Mean)
Paracetamol Caplet 1000 mg	5.82
Paracetamol Caplet 500 mg	3.73
Placebo Caplet	2.55

"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet - timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]." (NCT01082081)
Timeframe: Every two hours from baseline to 6 hours post dose

Participants Global Assessment to Response to Treatment (PGART)

Intervention	Units on a scale (Mean)
Paracetamol Caplet 1000 mg	8.05
Paracetamol Caplet 500 mg	5.18
Placebo Caplet	4.10

PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent. (NCT01075243)
Timeframe: Baseline to 6 hours post dose

Percentage of Participants Who Took Rescue Medication at 2 Hours

Intervention	Score on a scale (Mean)
Paracetamol Caplet 1000mg	2.20
Paracetamol Caplet 650 mg	1.80
Placebo Caplet	0.80

Percentage of participants who received rescue medication at different time points post dose. (NCT01075243)
Timeframe: Baseline to 2 hours post dose

Percentage of Participants Who Took Rescue Medication at 6 Hours

Intervention	Percentage of participants (Number)
Paracetamol Caplet 1000mg	0.00
Paracetamol Caplet 650 mg	0.00
Placebo Caplet	1.30

Percentage of participants who received rescue medication at different time points post dose. (NCT01075243)
Timeframe: Baseline to 6 hours post dose

SPID Scores at 4 Hours

Intervention	Percentage of participants (Number)
Paracetamol Caplet 1000mg	44.20
Paracetamol Caplet 650 mg	51.90
Placebo Caplet	70.00

"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline." (NCT01075243)
Timeframe: Every two hours from baseline to 4 hours post dose

SPID Scores at 6 Hours

Intervention	Score on a scale (Mean)
Paracetamol Caplet 1000mg	3.88
Paracetamol Caplet 650 mg	2.81
Placebo Caplet	0.20

"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline." (NCT01075243)
Timeframe: Every two hours from baseline to 6 hours post dose

SPRID at 2 Hours

Intervention	Score on a scale (Mean)
Paracetamol Caplet 1000mg	5.02
Paracetamol Caplet 650 mg	3.59
Placebo Caplet	0.34

SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -1.8 (least pain relief) to 12.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief (NCT01075243)
Timeframe: Every two hours from baseline to 2 hours post dose

SPRID at 4 Hours

Intervention	Score on a scale (Mean)
Paracetamol Caplet 1000mg	6.49
Paracetamol Caplet 650 mg	5.57
Placebo Caplet	1.55

SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -3.8 (least pain relief) to 26.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief (NCT01075243)
Timeframe: Every two hours from baseline to 4 hours post dose

Sum of Pain Intensity Difference (SPID) Scores at 2 Hours

Intervention	Score on a scale (Mean)
Paracetamol Caplet 1000mg	12.09
Paracetamol Caplet 650 mg	9.45
Placebo Caplet	3.00

"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline." (NCT01075243)
Timeframe: Every two hours from baseline to 2 hours post dose

Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)

Intervention	Score on a scale (Mean)
Paracetamol Caplet 1000mg	2.17
Paracetamol Caplet 650 mg	1.77
Placebo Caplet	0.19

SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief] (NCT01075243)
Timeframe: Every two hours from Baseline to 6 hours post dose

Time to Confirmed First Perceptible Relief

Intervention	Score on a scale (Mean)
Paracetamol Caplet 1000mg	16.08
Paracetamol Caplet 650 mg	12.42
Placebo Caplet	4.63

Time to Onset of Meaningful Pain Relief

Intervention	minutes (Mean)
Paracetamol Caplet 1000mg	54.72
Paracetamol Caplet 650 mg	69.67
Placebo Caplet	225.70

Participants recorded the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief. (NCT01075243)
Timeframe: Baseline to 6 hours post dose

Time to Start Using Rescue Medication

Intervention	minutes (Mean)
Paracetamol Caplet 1000mg	70.53
Paracetamol Caplet 650 mg	88.16
Placebo Caplet	247.14

Median time of use of rescue medication by participants. (NCT01075243)
Timeframe: Baseline to 6 hours post dose

Total Pain Relief Score (TOTPAR) at 2 Hours

Intervention	minutes (Median)
Paracetamol Caplet 1000 mg	360.00
Paracetamol Caplet 650 mg	314.00
Placebo Caplet	131.00

"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet - timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]." (NCT01075243)
Timeframe: Every two hours from baseline to 2 hours post dose

TOTPAR at 4 Hours

Intervention	Score on a scale (Mean)
Paracetamol Caplet 1000mg	4.31
Paracetamol Caplet 650 mg	3.80
Placebo Caplet	1.36

"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet - timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]." (NCT01075243)
Timeframe: Every two hours from baseline to 4 hours post dose

TOTPAR at 6 Hours

Intervention	Score on a scale (Mean)
Paracetamol Caplet 1000mg	8.21
Paracetamol Caplet 650 mg	6.64
Placebo Caplet	2.79

"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet - timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]." (NCT01075243)
Timeframe: Every two hours from baseline to 6 hours post dose

Duration of Analgesia - Time to Rescue

Intervention	Score on a scale (Mean)
Paracetamol Caplet 1000mg	11.06
Paracetamol Caplet 650 mg	8.83
Placebo Caplet	4.29

Minutes until rescue medication was given. (NCT01115673)
Timeframe: within 6 Hours

Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)

Intervention	Minutes (Median)
ACE-1000	NA
ACE-650	NA
ACE-0	99.5

Weighted Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief. For SPRID6, the total possible minimum value is -300 (worst) and the total possible maximum value is 1200 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point. (NCT01115673)
Timeframe: 6 Hours

Pain Intensity Difference (PID) at 120 Minutes

Intervention	units on a scale (Least Squares Mean)
ACE-1000	529.4
ACE-650	427.3
ACE-0	60.0

Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point. (NCT01115673)
Timeframe: 120 Minutes

Pain Intensity Difference (PID) at 15 Minutes

Intervention	units on a scale (Least Squares Mean)
ACE-1000	44.8
ACE-650	35.7
ACE-0	-2.7

Pain Intensity Difference (PID) at 180 Minutes

Intervention	units on a scale (Least Squares Mean)
ACE-1000	5.6
ACE-650	6.9
ACE-0	1.3

Pain Intensity Difference (PID) at 240 Minutes

Intervention	units on a scale (Least Squares Mean)
ACE-1000	40.8
ACE-650	31.9
ACE-0	-2.6

Pain Intensity Difference (PID) at 30 Minutes

Intervention	units on a scale (Least Squares Mean)
ACE-1000	40.8
ACE-650	30.3
ACE-0	-1.1

Pain Intensity Difference (PID) at 300 Minutes

Pain Intensity Difference (PID) at 360 Minutes

Pain Intensity Difference (PID) at 45 Minutes

Pain Intensity Difference (PID) at 60 Minutes

Pain Intensity Difference (PID) at 75 Minutes

Pain Intensity Difference (PID) from Baseline at Each Assessment Time Point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point. (NCT01115673)
Timeframe: 75 Minutes

Pain Intensity Difference (PID) at 90 Minutes

Pain Relief (PAR) Scores at 120 Minutes

Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100 (NCT01115673)
Timeframe: 120 Minutes

Pain Relief (PAR) Scores at 15 Minutes

Pain Relief (PAR) Scores at 180 Minutes

Pain Relief (PAR) Scores at 240 Minutes

Pain Relief (PAR) Scores at 30 Minutes

Pain Relief (PAR) Scores at 300 Minutes

Pain Relief (PAR) Scores at 360 Minutes

Pain Relief (PAR) Scores at 45 Minutes

Pain Relief (PAR) Scores at 60 Minutes

Pain Relief (PAR) Scores at 75 Minutes

Pain Relief (PAR) Scores at 90 Minutes

Patient Global Evaluation

Patient Assessment of the Pain Medication - Number of Subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent (NCT01115673)
Timeframe: 6 Hours

Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score

Percentage of Subjects with >50% of the Maximum Possible TOTPAR6 Score - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 600 so >50% is >300 out of 600 (NCT01115673)
Timeframe: 6 Hours

Rescue Rates Through Four Hours

Percentage of subjects using rescue medication. (NCT01115673)
Timeframe: through 4 Hours

Rescue Rates Through Six Hours

Percentage of subjects using rescue medication. (NCT01115673)
Timeframe: through 6 Hours

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes

Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief (NCT01115673)
Timeframe: 120 Minutes

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes

Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes

Sum of Pain Intensity Difference Over Six Hours (SPID6)

Weighted Sum of the Pain Intensity Difference from Baseline Over Six Hours (SPID6) - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain. The total possible minimum value is -300 (worst) and the total possible maximum value is 600 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point. (NCT01115673)
Timeframe: 6 Hours

Sum of Pain Relief Scores Over Six Hours (TOTPAR6)

Weighted Sum of the Pain Relief Scores Over Six Hours (TOTPAR6) - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief. The total possible minimum value is 0 (worst) and the total possible maximum value is 600 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point. (NCT01115673)
Timeframe: 6 Hours

Time to Confirmed Perceptible Pain Relief

Minutes until confirmed perceptible pain relief was achieved. A stopwatch was provided to the subject after ingestion of the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relieving effect whatsoever of the drug, that was when they first felt any pain relief. It did not necessarily mean they felt completely better, although they might have, but when they first felt any difference in the pain. (NCT01115673)
Timeframe: within 6 Hours

Time to Meaningful Pain Relief

Minutes until meaningful pain relief was achieved. A stopwatch was provided to the subject after ingestion of the study medication. The subject was instructed to stop the stopwatch when the relief from the starting pain was meaningful to them. (NCT01115673)
Timeframe: within 6 Hours

Opioid Side Effects

The Opioid-Related Symptom Distress Scale (ORSDS) is a Likert scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. Frequency is rated on a 4-point scale (1= 'Rarely', 4= 'Almost constantly'). Severity is rated on a 4-point scale (1= 'Slightly', 4= 'Very'). Bothersomeness is rated on a 5-point scale (0.8= 'Not at all', 4.0= 'Very much'). The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS score is the average of 12 symptom-specific scores. (NCT03020966)
Timeframe: 24 hours after surgery (Post-operative day 1)

Opioid Use

Oral morphine equivalents, cumulative, POD 0-3. Recorded in Medication Usage Database. (NCT03020966)
Timeframe: Day of surgery to post-operative day 3

Pain With Physical Therapy on Post-operative Day 1

Numerical rating scale of pain on a scale of 0-10, with 0 representing the minimum value of no pain and 10, representing the maximum, defined as being pain as bad as imaginable. (NCT03020966)
Timeframe: 24 hours after the operation (post-operative day 1)

PACU Length of Stay

Patient Reported Total Narcotic Use Post-discharge

Patient Satisfaction.

Patient satisfaction total scale from 1 to 10, with higher score indicating more satisfaction (NCT03558555)
Timeframe: 7 days post surgery

Total MME Intraoperatively

Total Morphine Milligram Equivalent (MME) use intraoperatively (NCT03558555)
Timeframe: Day 1

Total Narcotic Use in PACU.

Total narcotic use in PACU expressed in total morphine milligram equivalents (MME) (NCT03558555)
Timeframe: Day 1

PACU Visual Analogue Pain Scores

Post-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain. (NCT03558555)
Timeframe: baseline, 1 hour, and Day 1 discharge

Intervention	score on a scale (Mean)
	Baseline	1 hour	Discharge from PACU, up to 2.5 hours	6 hour post op	24 hour post op
Acetaminophen IV Soln	1.52	2.41	1.59	4.27	4.16
Oral Acetaminophen	2.13	2.88	1.45	3.82	3.64

Article	Year
Why Do We Prescribe Vicodin?. The Journal of the Michigan Dental Association, 2017, Volume: 99, Issue:5 Topics: Acetaminophen; Analgesics, Opioid; Drug Combinations; Drug Prescriptions; Humans; Hydrocodone; Molar	2017
Application of current pain management concepts to the prevention and management of postoperative pain. Journal of the American Dental Association (1939), 2013, Volume: 144, Issue:3 Topics: Acetaminophen; Analgesics, Opioid; Anesthetics, Local; Anti-Inflammatory Agents, Non-Steroidal; Cycl	2013
The application of clinical audit to improve pain control following third molar surgery. Dental update, 2013, Volume: 40, Issue:8 Topics: Acetaminophen; Adolescent; Adult; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal;	2013
Transnasal endoscopic approach to the impacted maxillary canine. The Journal of craniofacial surgery, 2014, Volume: 25, Issue:5 Topics: Acetaminophen; Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Cuspid; Endoscopy;	2014
Comparison of the efficacy of low doses of methylprednisolone, acetaminophen, and dexketoprofen trometamol on the swelling developed after the removal of impacted third molar. Medicina oral, patologia oral y cirugia bucal, 2015, Sep-01, Volume: 20, Issue:5 Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Edema; Humans; Ketoprofen; Methyl	2015
The value of the dental impaction pain model in drug development. Methods in molecular biology (Clifton, N.J.), 2010, Volume: 617 Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Drug Design; Human	2010
The value of the dental impaction pain model in drug development. Methods in molecular biology (Clifton, N.J.), 2010, Volume: 617 Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Drug Design; Human	2010
The value of the dental impaction pain model in drug development. Methods in molecular biology (Clifton, N.J.), 2010, Volume: 617 Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Drug Design; Human	2010
The value of the dental impaction pain model in drug development. Methods in molecular biology (Clifton, N.J.), 2010, Volume: 617 Topics: Acetaminophen; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Drug Design; Human	2010
Postoperative complaints following impacted mandibular third molar surgery in Ile-Ife, Nigeria. SADJ : journal of the South African Dental Association = tydskrif van die Suid-Afrikaanse Tandheelkundige Vereniging, 2002, Volume: 57, Issue:7 Topics: Acetaminophen; Adolescent; Adult; Analgesics, Non-Narcotic; Edema; Female; Humans; Ibuprofen; Male;	2002
Five studies on ibuprofen for postsurgical dental pain. The American journal of medicine, 1984, Jul-13, Volume: 77, Issue:1A Topics: Acetaminophen; Adolescent; Adult; Analgesics; Aspirin; Codeine; Drug Combinations; Female; Humans; I	1984
Comparison of diflunisal and paracetamol in the management of pain following wisdom teeth removal. British dental journal, 1982, Jan-05, Volume: 152, Issue:1 Topics: Acetaminophen; Adult; Aged; Diflunisal; Double-Blind Method; Female; Humans; Male; Middle Aged; Mola	1982
Effects of acetaminophen after bilateral oral surgery: double dose twice daily versus standard dose four times daily. Pharmacotherapy, 1991, Volume: 11, Issue:5 Topics: Acetaminophen; Adolescent; Adult; Analgesia; Drug Administration Schedule; Edema; Female; Humans; Ma	1991
The painful ear. Australian family physician, 1991, Volume: 20, Issue:12 Topics: Acetaminophen; Acute Disease; Adrenal Cortex Hormones; Adult; Amoxicillin; Anti-Bacterial Agents; Ch	1991
[Comparison of analgesic activity of mefenamic acid and paracetamol in treatment of pain after extraction of impacted lower 3d molar]. L' Information dentaire, 1991, May-30, Volume: 73, Issue:21 Topics: Acetaminophen; Adolescent; Adult; Double-Blind Method; Humans; Mandible; Mefenamic Acid; Molar, Thir	1991
Interrelation of complaints after removal of impacted mandibular third molars. International journal of oral surgery, 1985, Volume: 14, Issue:3 Topics: Acetaminophen; Adolescent; Adult; Consumer Behavior; Dexamethasone; Edema; Female; Humans; Male; Mol	1985