Page last updated: 2024-10-27

fentanyl and Pain, Breakthrough

fentanyl has been researched along with Pain, Breakthrough in 162 studies

Fentanyl: A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1078)
fentanyl : A monocarboxylic acid amide resulting from the formal condensation of the aryl amino group of N-phenyl-1-(2-phenylethyl)piperidin-4-amine with propanoic acid.

Research Excerpts

ExcerptRelevanceReference
"Rapid-acting fentanyl formulations are superior to oral morphine (OM) syrup in controlling breakthrough pain among patients with cancer, but they are expensive and unavailable in many countries."9.69Efficacy of reconstituted intravenous fentanyl to sublingual solution versus oral morphine syrup for breakthrough pain among patients with chronic gynecologic cancer pain: A randomized, double-blind, placebo-controlled trial. ( Thantiprechapong, T; Tilagul, T; Vasikasin, V, 2023)
"The purpose of this study was to evaluate the efficacy and safety of sublingual fentanyl in the treatment of breakthrough pain in cancer patients."9.41Efficacy, safety, and tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain: a randomized, double-blind, placebo-controlled study. ( Akbari, ME; Delshad, MH; Golmakani, E; Hashemi, M; Shadnoush, M; Zali, A, 2021)
" Intranasal fentanyl 100 µg or 200 µg was used to manage breakthrough pain on the first and third postoperative mornings in a randomised order."9.41Intranasal Fentanyl for Intervention-Associated Breakthrough Pain After Cardiac Surgery. ( Anderson, BJ; Hakomäki, H; Kokki, H; Kokki, M; Laakso, M; Ranta, VP; Rinne, V; Valtola, A, 2021)
"Oral morphine is frequently used for breakthrough pain but the oral route is not always available and absorption is slow."9.41Healthcare professionals' views of the use of oral morphine and transmucosal diamorphine in the management of paediatric breakthrough pain and the feasibility of a randomised controlled trial: A focus group study (DIPPER). ( Harrop, E; Howard, RF; Jamieson, L; Johnson, M; Liossi, C; Mott, C; Oulton, K; Skene, SS; Wong, IC, 2021)
"0625% with fentanyl 2 μg/mL at 12 mL/h, a patient-administered bolus of 5 mL at lockout 6-10 min and a maximum of four boluses per hour, and experiencing breakthrough pain ≥5/10, were randomized to receive a 10 mL bolus containing 12."9.34Comparative efficacy of epidural clonidine versus epidural fentanyl for treating breakthrough pain during labor: a randomized double-blind clinical trial. ( Goodman, S; Landau, R; Lavin, T; Lee, A; Menon, P; Smiley, R, 2020)
"Fentanyl buccal soluble film (FBSF), a new formulation of fentanyl, is developed for the treatment of breakthrough pain (BTP) in opioid-tolerant patients with cancer."9.30A dose titration study of fentanyl buccal soluble film for breakthrough cancer pain in Taiwan. ( Chang, YF; Chao, TC; Chao, TY; Chiou, TJ; Huang, JS; Wang, CH, 2019)
"The current study assessed the long-term safety of fentanyl sublingual spray for managing breakthrough cancer pain (BTCP)."9.22Long-term safety of fentanyl sublingual spray in opioid-tolerant patients with breakthrough cancer pain. ( Brownlow, RC; Bull, J; Minkowitz, H; Parikh, N; Rauck, R, 2016)
"To investigate the relationship between effective fentanyl sublingual spray (FSS) doses for breakthrough cancer pain (BTCP) and around-the-clock (ATC) transdermal fentanyl patch (TFP)."9.22Fentanyl sublingual spray for breakthrough cancer pain in patients receiving transdermal fentanyl. ( Alberts, DS; Parikh, N; Rauck, RL; Smith, CC, 2016)
"Fentanyl products have shown superiority over oral opioids for the management of breakthrough cancer pain (BTcP)."9.22Fentanyl Pectin Nasal Spray Versus Oral Morphine in Doses Proportional to the Basal Opioid Regimen for the Management of Breakthrough Cancer Pain: A Comparative Study. ( Adile, C; Aielli, F; Casuccio, A; Costanzi, A; Mercadante, S, 2016)
" The sublingual fentanyl orally disintegrating tablet is a formulation by which fentanyl can be rapidly absorbed across the oral mucosa producing rapid-onset analgesia, and which may be effective for breakthrough pain treatment."9.20Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined by titration for the treatment of breakthrough pain in Japanese cancer patients: a multicenter, randomized, placebo-controlled, double-blind phase III trial. ( Gomyo, I; Katakami, N; Ohta, E; Okada, M; Shimoyama, M; Shimoyama, N; Yukitoshi, N, 2015)
"Rapid analgesic onset opioids, particularly fentanyl buccal tablet, is preferable for managing breakthrough pain."9.20Breakthrough pain management using fentanyl buccal tablet (FBT) in combination with around-the-clock (ATC) opioids based on the efficacy and safety of FBT, and its relationship with ATC opioids: results from an open-label, multi-center study in Japanese c ( Adachi, I; Eguchi, K; Goto, F; Matoba, M; Shima, Y; Takigawa, C; Tanda, S; Yomiya, K; Yoshimoto, T, 2015)
"The aims of this study were to explore the efficacy of intranasal fentanyl spray* (INFS) 400 μg to evaluate 12-week tolerability of the nasal mucosa and to explore safety data for all dose strengths of INFS in patients with cancer-related breakthrough pain (BTP)."9.20Efficacy and tolerability of intranasal fentanyl spray in cancer patients with breakthrough pain. ( Eeg, M; Jaatun, E; Kaasa, S; Kvitberg, M; Popper, L; Thronæs, M, 2015)
" We evaluated the efficacy of sublingual fentanyl tablet (SLF) for the treatment of BTP in opioid-tolerant patients with chronic musculoskeletal pain with neuropathic component in terms of relief of pain intensity and assessed whether hypothetical pain relief impacts on quality of life (QoL)."9.20Efficacy and safety of sublingual fentanyl tablets for the management of breakthrough pain in patients with chronic musculoskeletal pain with neuropathic component: multicenter prospective study. ( Camba-Rodríguez, A; Cánovas-Martínez, L; Carceller-Ruiz, JJ; De la Iglesia-López, A; Díaz-Parada, P; Domínguez-Suárez, E; Freire-Vila, E; Iglesias, BG; Illodo-Miramontes, G; López-Ulloa, B, 2015)
"To investigate the long-term use of fentanyl pectin nasal spray (FPNS) for the treatment of breakthrough pain in cancer (BTPc) in patients receiving regular opioid therapy."9.19A report on the long-term use of fentanyl pectin nasal spray in patients with recurrent breakthrough pain. ( Ellershaw, JE; Perelman, M; Radbruch, L; Revnic, J; Taylor, D; Torres, LM, 2014)
"Oromucosal fentanyl is currently used for the treatment of breakthrough pain (BTP) in opioid-treated cancer patients."9.19A randomized, placebo-controlled study of a new sublingual formulation of fentanyl citrate (fentanyl ethypharm) for breakthrough pain in opioid-treated patients with cancer. ( Bullier, F; Fricova, J; Harabisova, S; Novotna, S; Richterova, E; Trinquet, F; Valentova, K, 2014)
"Opioid-tolerant patients with chronic pain who completed the previous randomized, double-blind, crossover portion of a study comparing fentanyl buccal tablet and immediate-release oxycodone for treatment of breakthrough pain."9.19Aberrant drug-related behavior observed during a 12-week open-label extension period of a study involving patients taking chronic opioid therapy for persistent pain and fentanyl buccal tablet or traditional short-acting opioid for breakthrough pain. ( Narayana, A; Passik, SD; Yang, R, 2014)
"Evaluate analgesic efficacy, functional benefit, and patient satisfaction with fentanyl buccal tablet vs immediate-release oxycodone for breakthrough pain (BTP)."9.17Fentanyl buccal tablet compared with immediate-release oxycodone for the management of breakthrough pain in opioid-tolerant patients with chronic cancer and noncancer pain: a randomized, double-blind, crossover study followed by a 12-week open-label phase ( Earl, CQ; Narayana, A; Slevin, KA; Webster, LR; Yang, R, 2013)
"The aim of this study was to evaluate the effectiveness and safety of sublingual fentanyl oral disintegrating tablets (sublingual fentanyl ODT) for the treatment of breakthrough pain (BTP), cancer or non-cancer related, in terms of relief of pain intensity, adverse events (AEs) and patient satisfaction, and to further examine the clinical and epidemiological profile of patients with BTP in a clinical setting."9.17Efficacy and safety of sublingual fentanyl orally disintegrating tablets in patients with breakthrough pain: multicentre prospective study. ( Aberasturi, T; Arilla, M; Coma, J; De Sanctis, V; Ferreras, J; Folch, J; Fuentes, J; Guitart, J; Lombán, E; Moya, J; Ribera, H; Rodelas, F; Salazar, R; Sintes, D; Tomás, A; Vargas, I; Vázquez, JM, 2013)
"Patients with bone-cancer pain, already on opioids, obtain clinically important, additional pain-control, with regular oxycodone/paracetamol dosing."9.16Efficacy of oxycodone/paracetamol for patients with bone-cancer pain: a multicenter, randomized, double-blinded, placebo-controlled trial. ( Fang, WX; Li, F; Sima, L; Wu, XM, 2012)
"Fentanyl buccal tablet (FBT) (FENTORA) is indicated for the management of breakthrough pain (BTP) in patients with cancer pain and who are tolerant to ≥60 mg of oral morphine equivalents, at least with the current availability of the minimal strength of 100 μg."8.91Fentanyl buccal tablet for the treatment of cancer-related breakthrough pain. ( Mercadante, S, 2015)
"The development of intranasal fentanyl (INFS) aimed for a rapid treatment of breakthrough pain (BTP) in cancer patients."8.88Population pharmacokinetic meta-analysis of intranasal fentanyl spray as a means to enrich pharmacokinetic information for patients with cancer breakthrough pain. ( Facius, A; Kaessner, N; Lahu, G; Nave, R; Roepcke, S, 2012)
"The purpose of this article is to systematically review the use of fentanyl as an analgesic for breakthrough pain."8.87Fentanyl for breakthrough pain: a systematic review. ( Davis, MP, 2011)
"After the CAVIDIOPAL study, we carried out an additional analysis to evaluate the impact of individualized management of breakthrough cancer pain, using the analgesic drug fentanyl, on quality of life (QoL) of advanced cancer patients receiving palliative care in Spain."8.12Low-dose sublingual fentanyl improves quality of life in patients with breakthrough cancer pain in palliative care. ( Abián, MH; Bermudo, CL; Canal-Sotelo, J; Casillas, IR; Mancilla, PG; Maradey, P; Rivero, SG; Rodríguez, AT; Viejo, MN, 2022)
"The aim of this paper was to assess the drug costs of the different biotechnologies (intranasal fentanyl spray (INFS), oral transmucosal fentanyl citrate (OTFC) and fentanyl buccal tablet (FBT)) in the treatment of breakthrough cancer pain (BTCP)."8.02The role of fentanyl in the treatment of breakthrough cancer pain: Different biotechnologies, different results and different drug costs. ( Bonetti, A; Fiorica, F; Franceschini, G; Giuliani, J; Sacchetto, A; Vaccari, F, 2021)
"The aim of the study was to evaluate the effectiveness of fentanyl pectin nasal spray (FPNS) in controlling procedural breakthrough cancer pain (BTCP) in advanced cancer patients undergoing radiotherapy."7.91Effectiveness of fentanyl pectin nasal citrate in controlling episodes of breakthrough cancer pain triggered by routine radiotherapy procedures. ( Aymar, N; Jiménez, E; Mena, A; Mestre, F; Ortiz, I; Pardo, J; Roncero, R; Vidal, M, 2019)
"Sublingual fentanyl tablets (SFTs) have been shown to be a safe and effective option in controlling breakthrough cancer pain (BTcP)."7.91Effects of Age Among Elderly Cancer Patients on Breakthrough Pain Management with Sublingual Fentanyl Tablets. ( Coma, J; De Sanctis, V; Estivill, P; Ferreras, J; Folch, J; Fuentes, J; Guitart, J; Jiménez, AJ; Moya, J; Rodelas, F; Salazar, R; Sanz, A; Tomás, A; Vargas, MI, 2019)
"In 2013, oral transmucosal fentanyl was first approved in Japan for reducing breakthrough pain(BTP)."7.85[A New Therapeutic Approach for Cancer-Related Breakthrough Pain - Focused on Oral Transmucosal Fentanyl]. ( Hosonuma, R; Kaneshima, M; Kyosaka, B; Osato, S; Warita, E; Yomiya, K, 2017)
"The aim of this study was to prospectively assess the efficacy and safety of low doses of sublingual fentanyl (SLF) for the treatment of breakthrough pain (BTP) in cancer patients in patients who were receiving low opioid doses for background analgesia."7.85The use of low doses of a sublingual fentanyl formulation for breakthrough pain in patients receiving low doses of opioids. ( Adile, C; Aielli, F; Casuccio, A; Cuomo, A; Marinangeli, F; Mercadante, S, 2017)
"A retrospective analysis was conduct on HNC patients during RT ± ChT that received fentanyl pectin na sal spray (FPNS) for incidental BTP due to painful mucositis 13 min before the main meals."7.85Fentanyl pectin nasal spray for painful mucositis in head and neck cancers during intensity-modulated radiation therapy with or without chemotherapy. ( Albanese, S; Alongi, F; Fersino, S; Fiorentino, A; Giaj-Levra, N; Gori, S; Mazzola, R; Ricchetti, F; Tebano, U, 2017)
"Data from opioid-tolerant patients participating in clinical studies of fentanyl buccal tablet (FBT) for breakthrough pain (up to 18 months of clinical study case-report forms) were retrospectively reviewed and coded for abuse, overdose, and aberrant behavior."7.77Aberrant drug-related behavior observed during clinical studies involving patients taking chronic opioid therapy for persistent pain and fentanyl buccal tablet for breakthrough pain. ( Golsorkhi, A; Messina, J; Passik, SD; Xie, F, 2011)
" Adverse events were somnolence and other events associated with opioids were mostly mild or moderate."6.79A randomized, double-blind, placebo-controlled study of fentanyl buccal tablets for breakthrough pain: efficacy and safety in Japanese cancer patients. ( Adachi, I; Eguchi, K; Goto, F; Hamada, S; Kosugi, T; Kunikane, H; Matoba, M; Shima, Y; Shinozaki, K; Takigawa, C; Tanda, S; Yomiya, K; Yoshimoto, T, 2014)
"Breakthrough cancer pain (BTcP) is recognized as a clinically significant complication of chronic cancer pain with most BTcP episodes peaking in intensity within a few minutes and lasting for approximately 30 min."6.79Efficacy of sublingual fentanyl vs. oral morphine for cancer-related breakthrough pain. ( España Ximénez de Enciso, I; García Velasco, P; Muñoz Garrido, JC; Velázquez Clavarana, L; Velázquez Rivera, I, 2014)
"However, the treatment of breakthrough pain should be adjusted to suit specific patient requirements."6.61The role of rapid onset fentanyl products in the management of breakthrough pain in cancer patients. ( Brząkała, J; Leppert, W, 2019)
" Furthermore, it is a reasonably safe treatment, causing generally mild adverse events not leading to treatment discontinuation."6.52Efficacy and Safety of Oral or Nasal Fentanyl for Treatment of Breakthrough Pain in Cancer Patients: A Systematic Review. ( Escobar, Y; Moya, J; Murillo, M; Rogríguez, D; Urrutia, G, 2015)
"Breakthrough cancer pain (BTCP) is common among cancer patients and markedly lowers their quality of life."6.49Fentanyl for the treatment of tumor-related breakthrough pain. ( Bornemann-Cimenti, H; Sandner-Kiesling, A; Szilagyi, IS; Wejbora, M, 2013)
" placebo in the first 30 minutes after dosing (FBT provided an 83% probability of superior pain relief, ODT 66%, and OTFC 73% vs."6.49Efficacy of rapid-onset oral fentanyl formulations vs. oral morphine for cancer-related breakthrough pain: a meta-analysis of comparative trials. ( Bennett, MI; Fullarton, JR; Jandhyala, R, 2013)
"Breakthrough cancer pain has been defined as a transitory increase in pain intensity that occurs either spontaneously or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain."6.48Oral trasmucosal fentanyl citrate for breakthrough pain treatment in cancer patients. ( Mercadante, S, 2012)
" Close examination of the existing trials assessing these newer transmucosal preparations reveals significant variation in many study parameters, such as patient selection criteria, severity of breakthrough pain episodes, proportions of patients with a neuropathic pain component, titration protocols, choice of the primary endpoints, protocols for repeat dosing and rescue medication, the separation of treated episodes and the extent of the placebo response, all of which may have affected efficacy results."6.47Newer generation fentanyl transmucosal products for breakthrough pain in opioid-tolerant cancer patients. ( Elsner, F; Porta-Sales, J; Tagarro, I; Zeppetella, G, 2011)
"Rapid-acting fentanyl formulations are superior to oral morphine (OM) syrup in controlling breakthrough pain among patients with cancer, but they are expensive and unavailable in many countries."5.69Efficacy of reconstituted intravenous fentanyl to sublingual solution versus oral morphine syrup for breakthrough pain among patients with chronic gynecologic cancer pain: A randomized, double-blind, placebo-controlled trial. ( Thantiprechapong, T; Tilagul, T; Vasikasin, V, 2023)
"Adverse drug reactions were registered in 3%."5.48Fentanyl buccal tablet for breakthrough cancer pain in clinical practice: results of the non-interventional prospective study ErkentNIS. ( Gneist, M; Landthaler, R; Masel, EK; Watzke, HH, 2018)
"No published studies have looked at the dosing and use of rapid onset fentanyl preparations in children."5.46The use of rapid onset fentanyl in children and young people for breakthrough cancer pain. ( Anderson, AK; Burke, K; Coombes, L, 2017)
"Fentanyl has a strong first pass effect when administered orally and resorbed enterally, however it is well suited for transmucosal administration, e."5.46[Transmucosal fentanyl administration: sublingual, buccal, nasal - all the same? Treatment of breakthrough cancer pain]. ( Überall, MA, 2017)
"The pharmacokinetics of the sublingual fentanyl orally disintegrating tablet appear to be negatively affected by the presence of salivary gland hypofunction, although the moistening of the oral cavity before dosing results in a pharmacokinetic profile similar to that seen with the giving of pilocarpine hydrochloride."5.43The Influence of Low Salivary Flow Rates on the Absorption of a Sublingual Fentanyl Citrate Formulation for Breakthrough Cancer Pain. ( Buchanan, A; Davies, A; Mundin, G; Vriens, J; Waghorn, M; Webber, K, 2016)
"The purpose of this study was to evaluate the efficacy and safety of sublingual fentanyl in the treatment of breakthrough pain in cancer patients."5.41Efficacy, safety, and tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain: a randomized, double-blind, placebo-controlled study. ( Akbari, ME; Delshad, MH; Golmakani, E; Hashemi, M; Shadnoush, M; Zali, A, 2021)
" Intranasal fentanyl 100 µg or 200 µg was used to manage breakthrough pain on the first and third postoperative mornings in a randomised order."5.41Intranasal Fentanyl for Intervention-Associated Breakthrough Pain After Cardiac Surgery. ( Anderson, BJ; Hakomäki, H; Kokki, H; Kokki, M; Laakso, M; Ranta, VP; Rinne, V; Valtola, A, 2021)
"Oral morphine is frequently used for breakthrough pain but the oral route is not always available and absorption is slow."5.41Healthcare professionals' views of the use of oral morphine and transmucosal diamorphine in the management of paediatric breakthrough pain and the feasibility of a randomised controlled trial: A focus group study (DIPPER). ( Harrop, E; Howard, RF; Jamieson, L; Johnson, M; Liossi, C; Mott, C; Oulton, K; Skene, SS; Wong, IC, 2021)
"0625% with fentanyl 2 μg/mL at 12 mL/h, a patient-administered bolus of 5 mL at lockout 6-10 min and a maximum of four boluses per hour, and experiencing breakthrough pain ≥5/10, were randomized to receive a 10 mL bolus containing 12."5.34Comparative efficacy of epidural clonidine versus epidural fentanyl for treating breakthrough pain during labor: a randomized double-blind clinical trial. ( Goodman, S; Landau, R; Lavin, T; Lee, A; Menon, P; Smiley, R, 2020)
"Fentanyl buccal soluble film (FBSF), a new formulation of fentanyl, is developed for the treatment of breakthrough pain (BTP) in opioid-tolerant patients with cancer."5.30A dose titration study of fentanyl buccal soluble film for breakthrough cancer pain in Taiwan. ( Chang, YF; Chao, TC; Chao, TY; Chiou, TJ; Huang, JS; Wang, CH, 2019)
" This open-label, multicenter, noncomparative study aimed to assess the efficacy and safety of proportional doses of fentanyl buccal soluble film (FBSF) in patients with breakthrough cancer pain."5.27Proportional dose of rapid-onset opioid in breakthrough cancer pain management: An open-label, multicenter study. ( Chiang, WY; Chiou, JF; Hu, MH; Huang, MY; Lai, YL; Su, WH; Wu, SC; Yen, TY, 2018)
" The string was "rapid onset opioids" or "transmucosal fentanyl" and "breakthrough cancer pain"."5.22Bibliometric Network Analysis on Rapid-Onset Opioids for Breakthrough Cancer Pain Treatment. ( Armignacco, A; Carpenedo, R; Cascella, M; Chinè, E; Coluccia, S; Crispo, A; Cuomo, A; Cutugno, F; Forte, CA; Franceschini, G; Gennaro, PD; Migliaccio, L; Monaco, F; Natoli, S; Nocerino, D; Picerno, P; Tafuri, M; Tracey, MC; Vittori, A, 2022)
"The current study assessed the long-term safety of fentanyl sublingual spray for managing breakthrough cancer pain (BTCP)."5.22Long-term safety of fentanyl sublingual spray in opioid-tolerant patients with breakthrough cancer pain. ( Brownlow, RC; Bull, J; Minkowitz, H; Parikh, N; Rauck, R, 2016)
"To investigate the relationship between effective fentanyl sublingual spray (FSS) doses for breakthrough cancer pain (BTCP) and around-the-clock (ATC) transdermal fentanyl patch (TFP)."5.22Fentanyl sublingual spray for breakthrough cancer pain in patients receiving transdermal fentanyl. ( Alberts, DS; Parikh, N; Rauck, RL; Smith, CC, 2016)
"Fentanyl products have shown superiority over oral opioids for the management of breakthrough cancer pain (BTcP)."5.22Fentanyl Pectin Nasal Spray Versus Oral Morphine in Doses Proportional to the Basal Opioid Regimen for the Management of Breakthrough Cancer Pain: A Comparative Study. ( Adile, C; Aielli, F; Casuccio, A; Costanzi, A; Mercadante, S, 2016)
" The sublingual fentanyl orally disintegrating tablet is a formulation by which fentanyl can be rapidly absorbed across the oral mucosa producing rapid-onset analgesia, and which may be effective for breakthrough pain treatment."5.20Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined by titration for the treatment of breakthrough pain in Japanese cancer patients: a multicenter, randomized, placebo-controlled, double-blind phase III trial. ( Gomyo, I; Katakami, N; Ohta, E; Okada, M; Shimoyama, M; Shimoyama, N; Yukitoshi, N, 2015)
" The doses of sublingual fentanyl to treat breakthrough pain were determined from rescue morphine doses by use of conversion ratios."5.20Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined from oral morphine rescue doses in the treatment of breakthrough cancer pain. ( Gomyo, I; Higuchi, H; Kojima, K; Ohta, E; Shimoyama, M; Shimoyama, N; Teramoto, O; Yukitoshi, N, 2015)
"Rapid analgesic onset opioids, particularly fentanyl buccal tablet, is preferable for managing breakthrough pain."5.20Breakthrough pain management using fentanyl buccal tablet (FBT) in combination with around-the-clock (ATC) opioids based on the efficacy and safety of FBT, and its relationship with ATC opioids: results from an open-label, multi-center study in Japanese c ( Adachi, I; Eguchi, K; Goto, F; Matoba, M; Shima, Y; Takigawa, C; Tanda, S; Yomiya, K; Yoshimoto, T, 2015)
"The aims of this study were to explore the efficacy of intranasal fentanyl spray* (INFS) 400 μg to evaluate 12-week tolerability of the nasal mucosa and to explore safety data for all dose strengths of INFS in patients with cancer-related breakthrough pain (BTP)."5.20Efficacy and tolerability of intranasal fentanyl spray in cancer patients with breakthrough pain. ( Eeg, M; Jaatun, E; Kaasa, S; Kvitberg, M; Popper, L; Thronæs, M, 2015)
" We evaluated the efficacy of sublingual fentanyl tablet (SLF) for the treatment of BTP in opioid-tolerant patients with chronic musculoskeletal pain with neuropathic component in terms of relief of pain intensity and assessed whether hypothetical pain relief impacts on quality of life (QoL)."5.20Efficacy and safety of sublingual fentanyl tablets for the management of breakthrough pain in patients with chronic musculoskeletal pain with neuropathic component: multicenter prospective study. ( Camba-Rodríguez, A; Cánovas-Martínez, L; Carceller-Ruiz, JJ; De la Iglesia-López, A; Díaz-Parada, P; Domínguez-Suárez, E; Freire-Vila, E; Iglesias, BG; Illodo-Miramontes, G; López-Ulloa, B, 2015)
"To investigate the long-term use of fentanyl pectin nasal spray (FPNS) for the treatment of breakthrough pain in cancer (BTPc) in patients receiving regular opioid therapy."5.19A report on the long-term use of fentanyl pectin nasal spray in patients with recurrent breakthrough pain. ( Ellershaw, JE; Perelman, M; Radbruch, L; Revnic, J; Taylor, D; Torres, LM, 2014)
"Oromucosal fentanyl is currently used for the treatment of breakthrough pain (BTP) in opioid-treated cancer patients."5.19A randomized, placebo-controlled study of a new sublingual formulation of fentanyl citrate (fentanyl ethypharm) for breakthrough pain in opioid-treated patients with cancer. ( Bullier, F; Fricova, J; Harabisova, S; Novotna, S; Richterova, E; Trinquet, F; Valentova, K, 2014)
"The aim of this randomized, crossover, comparison study was to assess the analgesic and adverse effects of 2 nasal preparations, intranasal fentanyl (INFS) and fentanyl pectin nasal spray (FPNS), for breakthrough pain, given in doses proportional to opioid basal regimen."5.19Intranasal fentanyl versus fentanyl pectin nasal spray for the management of breakthrough cancer pain in doses proportional to basal opioid regimen. ( Adile, C; Casuccio, A; Mercadante, S; Prestia, G, 2014)
"Opioid-tolerant patients with chronic pain who completed the previous randomized, double-blind, crossover portion of a study comparing fentanyl buccal tablet and immediate-release oxycodone for treatment of breakthrough pain."5.19Aberrant drug-related behavior observed during a 12-week open-label extension period of a study involving patients taking chronic opioid therapy for persistent pain and fentanyl buccal tablet or traditional short-acting opioid for breakthrough pain. ( Narayana, A; Passik, SD; Yang, R, 2014)
"Intranasal Fentanyl Spray (INFS) was developed for the treatment of breakthrough pain (BTP) in cancer patients using a new route of administration."5.17An innovative phase I population pharmacokinetic approach to investigate the pharmacokinetics of an intranasal fentanyl spray in healthy subjects. ( Baumann, S; Facius, A; Hartmann, L; Nave, R; Plock, N, 2013)
"Evaluate analgesic efficacy, functional benefit, and patient satisfaction with fentanyl buccal tablet vs immediate-release oxycodone for breakthrough pain (BTP)."5.17Fentanyl buccal tablet compared with immediate-release oxycodone for the management of breakthrough pain in opioid-tolerant patients with chronic cancer and noncancer pain: a randomized, double-blind, crossover study followed by a 12-week open-label phase ( Earl, CQ; Narayana, A; Slevin, KA; Webster, LR; Yang, R, 2013)
"The aim of this study was to evaluate the effectiveness and safety of sublingual fentanyl oral disintegrating tablets (sublingual fentanyl ODT) for the treatment of breakthrough pain (BTP), cancer or non-cancer related, in terms of relief of pain intensity, adverse events (AEs) and patient satisfaction, and to further examine the clinical and epidemiological profile of patients with BTP in a clinical setting."5.17Efficacy and safety of sublingual fentanyl orally disintegrating tablets in patients with breakthrough pain: multicentre prospective study. ( Aberasturi, T; Arilla, M; Coma, J; De Sanctis, V; Ferreras, J; Folch, J; Fuentes, J; Guitart, J; Lombán, E; Moya, J; Ribera, H; Rodelas, F; Salazar, R; Sintes, D; Tomás, A; Vargas, I; Vázquez, JM, 2013)
"Effective labour analgesia lasting up to 120 minutes was observed in the fentanyl-bupivacaine group but with high incidence of breakthrough pain."5.17A COMPARATIVE STUDY ON THE EFFICACY OF TWO REGIMENS OF SINGLE- SHOT SPINAL BLOCK FOR PAIN RELIEF IN WOMEN PRESENTING IN ESTABLISHED LABOUR. ( Chokwe, TM; Ogutu, O; Olang, PO; Tshibuyl, PN, 2013)
"Patients with bone-cancer pain, already on opioids, obtain clinically important, additional pain-control, with regular oxycodone/paracetamol dosing."5.16Efficacy of oxycodone/paracetamol for patients with bone-cancer pain: a multicenter, randomized, double-blinded, placebo-controlled trial. ( Fang, WX; Li, F; Sima, L; Wu, XM, 2012)
"Data were derived from 2 clinical trials (Study 1, n=131; Study 2, n=139) of fentanyl sublingual tablet in patients with cancer-associated breakthrough pain (BTP)."5.16Successful dose finding with sublingual fentanyl tablet: combined results from 2 open-label titration studies. ( Hassman, D; Howell, J; Nalamachu, SR; Rauck, RL; Wallace, MS, 2012)
" Fentanyl is a lipophilic opioid commonly proposed for intranasal use among pediatric patients, but no studies have been conducted yet about intranasal use of other available opioids for management of pediatric cancer pain."5.01Intranasal therapy with opioids for children and adolescents with cancer: results from clinical studies. ( Attinà, G; Capozza, MA; Mastrangelo, S; Maurizi, P; Ruggiero, A; Triarico, S, 2019)
" A group of experts nominated by the 3 French Societies involved in the treatment of cancer pain (AFSOS, SFAP, SFETD), established new guidelines ratios for morphine switching and/or changing of route of administration, in patients for whom either pain was not adequatly managed or adverse effects were unbearable."4.98[Opioid switch and change of route of administration in cancer patients treated by morphine]. ( Ammar, D; Baron, L; Chvetzoff, G; Collin, E; Delorme, C; Delorme, T; Faure, S; Filbet, M; Hubault, P; Jovenin, N; Krakowski, I; Magnet, M; Michenot, N; Minello, C; Poulain, P; Rostaing, S, 2018)
"Fentanyl buccal tablet (FBT) (FENTORA) is indicated for the management of breakthrough pain (BTP) in patients with cancer pain and who are tolerant to ≥60 mg of oral morphine equivalents, at least with the current availability of the minimal strength of 100 μg."4.91Fentanyl buccal tablet for the treatment of cancer-related breakthrough pain. ( Mercadante, S, 2015)
"The original review included four studies (393 participants), all concerned with the use of oral transmucosal fentanyl citrate (OTFC) in the management of breakthrough pain."4.89Opioids for the management of breakthrough pain in cancer patients. ( Davies, AN; Zeppetella, G, 2013)
"Fentanyl buccal tablet (FBT) is indicated for the treatment of breakthrough pain in patients who are already receiving and are tolerant to opioid therapy for underlying, persistent cancer pain."4.88Pharmacokinetics of fentanyl buccal tablet: a pooled analysis and review. ( Darwish, M; Xie, F, 2012)
"The development of intranasal fentanyl (INFS) aimed for a rapid treatment of breakthrough pain (BTP) in cancer patients."4.88Population pharmacokinetic meta-analysis of intranasal fentanyl spray as a means to enrich pharmacokinetic information for patients with cancer breakthrough pain. ( Facius, A; Kaessner, N; Lahu, G; Nave, R; Roepcke, S, 2012)
"The purpose of this article is to systematically review the use of fentanyl as an analgesic for breakthrough pain."4.87Fentanyl for breakthrough pain: a systematic review. ( Davis, MP, 2011)
"After the CAVIDIOPAL study, we carried out an additional analysis to evaluate the impact of individualized management of breakthrough cancer pain, using the analgesic drug fentanyl, on quality of life (QoL) of advanced cancer patients receiving palliative care in Spain."4.12Low-dose sublingual fentanyl improves quality of life in patients with breakthrough cancer pain in palliative care. ( Abián, MH; Bermudo, CL; Canal-Sotelo, J; Casillas, IR; Mancilla, PG; Maradey, P; Rivero, SG; Rodríguez, AT; Viejo, MN, 2022)
"The aim of this paper was to assess the drug costs of the different biotechnologies (intranasal fentanyl spray (INFS), oral transmucosal fentanyl citrate (OTFC) and fentanyl buccal tablet (FBT)) in the treatment of breakthrough cancer pain (BTCP)."4.02The role of fentanyl in the treatment of breakthrough cancer pain: Different biotechnologies, different results and different drug costs. ( Bonetti, A; Fiorica, F; Franceschini, G; Giuliani, J; Sacchetto, A; Vaccari, F, 2021)
"Fentanyl buccal tablet (FBT), a potent opioid, was approved in Canada in 2013 for breakthrough pain in opioid-tolerant adult cancer patients."3.96Effectiveness of Risk Minimization Measures for Fentanyl Buccal Tablet (FENTORA) in Canada: A Mixed-Methods Evaluation Using Surveys, Medical Chart Records and Web Surveillance. ( Bergamasco, A; Castilloux, AM; Kaplan, S; Moride, Y; Sergerie, M, 2020)
"Immediate-release fentanyl is indicated in the treatment of breakthrough pain in cancer patients who already receive opioids as background chronic analgesia."3.96[Comparison of hospital consumption of immediate-release fentanyl: use or abuse?] ( Arrieta Loitegui, M; Caro Teller, JM; Ferrari Piquero, JM; Rosas Espinoza, C, 2020)
"Oral transmucosal fentanyl has been indicated for the management of breakthrough pain in patients with cancer."3.96[A Case Report of Impaired Consciousness in a Patient after Receiving the Fourth Dose of Fentanyl Sublingual Tablet]. ( Kono, T; Satomi, M, 2020)
"Transmucosal immediate-release fentanyls (TIRFs), indicated solely for breakthrough cancer pain in opioid-tolerant patients, are subject to a US Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) to prevent them from being prescribed inappropriately."3.91Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release Fentanyl Products. ( Alexander, GC; Heyward, J; Lurie, P; Olson, L; Rollman, JE; Sharfstein, J, 2019)
" We describe the case of a patient suffering from breaktrough cancer pain treated with sublingual fentanyl."3.91[Breaktrough cancer pain in metastatic prostate adenocarcinoma: a case report.] ( Miolo, G; Santeufemia, DA, 2019)
"The aim of the study was to evaluate the effectiveness of fentanyl pectin nasal spray (FPNS) in controlling procedural breakthrough cancer pain (BTCP) in advanced cancer patients undergoing radiotherapy."3.91Effectiveness of fentanyl pectin nasal citrate in controlling episodes of breakthrough cancer pain triggered by routine radiotherapy procedures. ( Aymar, N; Jiménez, E; Mena, A; Mestre, F; Ortiz, I; Pardo, J; Roncero, R; Vidal, M, 2019)
"Sublingual fentanyl tablets (SFTs) have been shown to be a safe and effective option in controlling breakthrough cancer pain (BTcP)."3.91Effects of Age Among Elderly Cancer Patients on Breakthrough Pain Management with Sublingual Fentanyl Tablets. ( Coma, J; De Sanctis, V; Estivill, P; Ferreras, J; Folch, J; Fuentes, J; Guitart, J; Jiménez, AJ; Moya, J; Rodelas, F; Salazar, R; Sanz, A; Tomás, A; Vargas, MI, 2019)
"In 2013, oral transmucosal fentanyl was first approved in Japan for reducing breakthrough pain(BTP)."3.85[A New Therapeutic Approach for Cancer-Related Breakthrough Pain - Focused on Oral Transmucosal Fentanyl]. ( Hosonuma, R; Kaneshima, M; Kyosaka, B; Osato, S; Warita, E; Yomiya, K, 2017)
" Group 1 was consisted of 353 patients whose basal cancer pain of intensity 4-7 NRS was treated weak opiates (basal analgetic- fixed combination of tramadol/paracetamol (37."3.85Characteristics and Treatment of Breakthrought Pain (BTcP) in Palliative Care. ( Husic, S; Imamovic, S; Matic, S; Sukalo, A, 2017)
"The aim of this study was to prospectively assess the efficacy and safety of low doses of sublingual fentanyl (SLF) for the treatment of breakthrough pain (BTP) in cancer patients in patients who were receiving low opioid doses for background analgesia."3.85The use of low doses of a sublingual fentanyl formulation for breakthrough pain in patients receiving low doses of opioids. ( Adile, C; Aielli, F; Casuccio, A; Cuomo, A; Marinangeli, F; Mercadante, S, 2017)
"A retrospective analysis was conduct on HNC patients during RT ± ChT that received fentanyl pectin na sal spray (FPNS) for incidental BTP due to painful mucositis 13 min before the main meals."3.85Fentanyl pectin nasal spray for painful mucositis in head and neck cancers during intensity-modulated radiation therapy with or without chemotherapy. ( Albanese, S; Alongi, F; Fersino, S; Fiorentino, A; Giaj-Levra, N; Gori, S; Mazzola, R; Ricchetti, F; Tebano, U, 2017)
"Instanyl® (intranasal fentanyl spray) is a novel treatment for breakthrough pain (BTP) in cancer patients."3.80The use of Instanyl® in the treatment of breakthrough pain in cancer patients: a 3-month observational, prospective, cohort study. ( Eeg, M; Greisen, H; Kongsgaard, UE, 2014)
" The past decade has seen clinical trials of transmucosal opioid formulations for breakthrough pain in cancer (BTPc), beginning with oral transmucosal fentanyl citrate (OTFC), followed by fentanyl buccal tablet and intranasal fentanyl spray, and most recently sublingual fentanyl tablet, fentanyl buccal soluble film, and fentanyl pectin nasal spray."3.79Evidence-based treatment of cancer-related breakthrough pain with opioids. ( Zeppetella, G, 2013)
"Three transmucosal fentanyl products have recently been licensed for cancer-related breakthrough pain: a sublingual tablet, a buccal/sublingual tablet and a nasal spray."3.77How practical are transmucosal fentanyl products for breakthrough cancer pain? Novel use of placebo formulations to survey user opinion. ( England, R; Maddocks, M; Manderson, C; Wilcock, A; Zadora-Chrzastowska, S, 2011)
"Data from opioid-tolerant patients participating in clinical studies of fentanyl buccal tablet (FBT) for breakthrough pain (up to 18 months of clinical study case-report forms) were retrospectively reviewed and coded for abuse, overdose, and aberrant behavior."3.77Aberrant drug-related behavior observed during clinical studies involving patients taking chronic opioid therapy for persistent pain and fentanyl buccal tablet for breakthrough pain. ( Golsorkhi, A; Messina, J; Passik, SD; Xie, F, 2011)
"Breakthrough cancer pain (BTCP) is associated with decreased satisfaction with around-the-clock opioid therapy."2.80Patient Satisfaction with Fentanyl Sublingual Spray in Opioid-Tolerant Patients with Breakthrough Cancer Pain. ( Barker, J; Dillaha, L; Parikh, N; Rauck, R; Stearns, L, 2015)
"Opioid-tolerant patients with chronic cancer-related pain who experienced up to four breakthrough pain episodes daily were randomized to a starting dose of 100 or 200 μg for the titration period."2.80Pan-European, open-label dose titration study of fentanyl buccal tablet in patients with breakthrough cancer pain. ( Davies, A; Jarosz, J; Kleeberg, UR; Kress, HG; Mercadante, S; O'Brien, T; Poulain, P; Schneid, H, 2015)
" Adverse events were somnolence and other events associated with opioids were mostly mild or moderate."2.79A randomized, double-blind, placebo-controlled study of fentanyl buccal tablets for breakthrough pain: efficacy and safety in Japanese cancer patients. ( Adachi, I; Eguchi, K; Goto, F; Hamada, S; Kosugi, T; Kunikane, H; Matoba, M; Shima, Y; Shinozaki, K; Takigawa, C; Tanda, S; Yomiya, K; Yoshimoto, T, 2014)
"Breakthrough cancer pain (BTcP) is recognized as a clinically significant complication of chronic cancer pain with most BTcP episodes peaking in intensity within a few minutes and lasting for approximately 30 min."2.79Efficacy of sublingual fentanyl vs. oral morphine for cancer-related breakthrough pain. ( España Ximénez de Enciso, I; García Velasco, P; Muñoz Garrido, JC; Velázquez Clavarana, L; Velázquez Rivera, I, 2014)
"A total of 82 cancer patients with BTcP who were receiving strong opioids in doses of at least 60 mg of oral morphine equivalents and having acceptable background analgesia, were selected for a multicenter unblinded study."2.77Dosing fentanyl buccal tablet for breakthrough cancer pain: dose titration versus proportional doses. ( Adile, C; Aielli, F; Casuccio, A; Gatti, A; Lo Presti, C; Mercadante, S; Porzio, G, 2012)
"Head and neck cancers (HNC) represent 5% of all malignancies worldwide with about 180,000 cancer deaths per year."2.66Is pain part of a systemic syndrome in head and neck cancer? ( Argenone, A; Bossi, P; Depenni, R; Ghiani, M, 2020)
"Treatment directed towards painful metastases must be considered."2.66Breakthrough cancer pain in 2020. ( Klepstad, P; Løhre, ET; Thronæs, M, 2020)
"However, the treatment of breakthrough pain should be adjusted to suit specific patient requirements."2.61The role of rapid onset fentanyl products in the management of breakthrough pain in cancer patients. ( Brząkała, J; Leppert, W, 2019)
"Flares of breathlessness are accompanied by degrees of psychological distress, although it is unclear whether psychological factors may precede or be induced by EB."2.58Episodic Breathlessness in Patients with Advanced Cancer: Characteristics and Management. ( Mercadante, S, 2018)
"Fentanyl is a synthetic, highly selective opioid with many desirable physicochemical properties, including a high lipophilicity and predictable pharmacokinetics."2.55Fentanyl Formulations in the Management of Pain: An Update. ( Schug, SA; Ting, S, 2017)
" Five studies and guidelines also suggest that oral opioids (not including TIRF products) be dosed proportionally to baseline opioids at 10%-20% of the 24-hour, around-the-clock dose."2.55Breakthrough Cancer Pain: A Systematic Review of Pharmacologic Management
. ( Brant, JM; Gallagher, E; Rodgers, BB; Sundaramurthi, T, 2017)
"The management of cancer pain presents manifold challenges: even though background pain is adequately controlled, patients frequently experience episodes of acute pain exacerbation known as breakthrough cancer pain (BTcP)."2.53Fentanyl citrate sublingual formulation (Vellofent®) for quick BTcP hindering. ( Candeletti, S; Romualdi, P, 2016)
" Furthermore, it is a reasonably safe treatment, causing generally mild adverse events not leading to treatment discontinuation."2.52Efficacy and Safety of Oral or Nasal Fentanyl for Treatment of Breakthrough Pain in Cancer Patients: A Systematic Review. ( Escobar, Y; Moya, J; Murillo, M; Rogríguez, D; Urrutia, G, 2015)
" These dosage forms offer overlapping yet distinct pharmacokinetic advantages to allow more choices for physicians and patients in the management of breakthrough cancer pain."2.50Clinical and pharmacokinetic considerations of novel formulations of fentanyl for breakthrough cancer pain. ( Chen, C; Gupta, A, 2014)
"Breakthrough cancer pain (BTCP) is common among cancer patients and markedly lowers their quality of life."2.49Fentanyl for the treatment of tumor-related breakthrough pain. ( Bornemann-Cimenti, H; Sandner-Kiesling, A; Szilagyi, IS; Wejbora, M, 2013)
"Breakthrough cancer pain has been defined as a transitory increase in pain intensity that occurs despite relatively stable and adequately controlled background pain."2.49[Management of breakthrough cancer pain]. ( Sláma, O, 2013)
"Fentanyl is a synthetic opioid characterized by rapid absorption and start of the analgesic effects."2.49Optimal management of breakthrough cancer pain (BCP). ( Antón, A; Casas, A; Cruz, JJ; Escobar, Y; Gálvez, R; Juliá, J; López, R; Mañas, A; Margarit, C; Zaragozá, F, 2013)
" placebo in the first 30 minutes after dosing (FBT provided an 83% probability of superior pain relief, ODT 66%, and OTFC 73% vs."2.49Efficacy of rapid-onset oral fentanyl formulations vs. oral morphine for cancer-related breakthrough pain: a meta-analysis of comparative trials. ( Bennett, MI; Fullarton, JR; Jandhyala, R, 2013)
" The primary outcome was improvement in PID during the first 60 min after dosing (15-60 min)."2.48Various formulations of oral transmucosal fentanyl for breakthrough cancer pain: an indirect mixed treatment comparison meta-analysis. ( Fullarton, J; Jandhyala, R, 2012)
"Breakthrough cancer pain has been defined as a transitory increase in pain intensity that occurs either spontaneously or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain."2.48Oral trasmucosal fentanyl citrate for breakthrough pain treatment in cancer patients. ( Mercadante, S, 2012)
"Breakthrough pain is characterized by a sudden onset and rapid increase in the pain level and should be treated with correspondingly rapidly effective opioids."2.47[Cancer breakthrough pain. Indications for rapidly effective opioids]. ( Bardenheuer, HJ; Kessler, J, 2011)
"The usual management of cancer related breakthrough pain is with supplemental doses of analgesics (commonly opioids) at a dose proportional to the total around-the-clock opioid dose."2.47Opioids for the management of breakthrough cancer pain in adults: a systematic review undertaken as part of an EPCRC opioid guidelines project. ( Zeppetella, G, 2011)
" Close examination of the existing trials assessing these newer transmucosal preparations reveals significant variation in many study parameters, such as patient selection criteria, severity of breakthrough pain episodes, proportions of patients with a neuropathic pain component, titration protocols, choice of the primary endpoints, protocols for repeat dosing and rescue medication, the separation of treated episodes and the extent of the placebo response, all of which may have affected efficacy results."2.47Newer generation fentanyl transmucosal products for breakthrough pain in opioid-tolerant cancer patients. ( Elsner, F; Porta-Sales, J; Tagarro, I; Zeppetella, G, 2011)
"In comparison with other tumors, in patients with MM BTcP was more predictable (p=0."1.91Breakthrough pain in patients with multiple myeloma: a secondary analysis of IOPS MS study. ( Caraceni, A; Cuomo, A; Mammucari, M; Marchetti, P; Mediati, RD; Mercadante, S; Natoli, S; Tonini, G, 2023)
"Patients who required treatment of breakthrough pain had higher patient-controlled epidural boluses demands-to-delivery ratio."1.91Association between breakthrough labor pain, patient-controlled epidural analgesia use, and numeracy: A pilot observational study. ( Kim, J; Klumpner, TT; Lange, EMS; McCarthy, RJ; Thakkar, K; Toledo, P; Wong, CA, 2023)
" A strong consensus was achieved regarding which pharmacological treatment (transmucosal fentanyl) and dosing method (start low and go slow) are the most suitable for the older population."1.51Expert consensus on the management of breakthrough cancer pain in older patients. A Delphi study. ( Alarcón, MDL; Cabezón-Gutiérrez, L; Estévez, FV; Jiménez-López, AJ; Martín-Arroyo, JMT; Padrós, MC; Rebollo, MA; Sanz-Yagüe, A, 2019)
"Adverse drug reactions were registered in 3%."1.48Fentanyl buccal tablet for breakthrough cancer pain in clinical practice: results of the non-interventional prospective study ErkentNIS. ( Gneist, M; Landthaler, R; Masel, EK; Watzke, HH, 2018)
"Our objective was to assess the effect of sublingual fentanyl tablets (SFTs) on pain relief, quality of life, and adverse effects in patients with cancer pain, according to cancer stage and background opioid regimen."1.48Efficacy and Safety of Sublingual Fentanyl Tablets in Breakthrough Cancer Pain Management According to Cancer Stage and Background Opioid Medication. ( Coma, J; De Sanctis, V; Estivill, P; Ferreras, J; Folch, J; Fuentes, J; Guitart, J; Jiménez, AJ; Moya, J; Rodelas, F; Salazar, R; Sanz, A; Tomás, A; Vargas, MI, 2018)
" TIRF use was mainly related to background opioid dosage and the patient's self-sufficiency in taking medication."1.48Breakthrough cancer pain tailored treatment: which factors influence the medication choice? An observational, prospective and cross-sectional study in patients with terminal cancer. ( Calvieri, A; Casale, G; Dardeli, A; Eusepi, G; Giannarelli, D; Magnani, C; Mastroianni, C; Restuccia, MR, 2018)
" Nausea, vomiting, somnolence, and dizziness were the most frequent treatment-related adverse events (AEs), and all AEs were grade 1 (mild) or 2 (moderate)."1.48Initial titration with 200 μg fentanyl buccal tablets: a retrospective safety analysis in Korean cancer patients. ( Cho, HN; Koo, DH; Kwon, MY; Lee, SS; Lee, YG; Oh, S, 2018)
"No published studies have looked at the dosing and use of rapid onset fentanyl preparations in children."1.46The use of rapid onset fentanyl in children and young people for breakthrough cancer pain. ( Anderson, AK; Burke, K; Coombes, L, 2017)
"Fentanyl has a strong first pass effect when administered orally and resorbed enterally, however it is well suited for transmucosal administration, e."1.46[Transmucosal fentanyl administration: sublingual, buccal, nasal - all the same? Treatment of breakthrough cancer pain]. ( Überall, MA, 2017)
"The recommended dosing interval for transdermal fentanyl is every 72 h."1.43A new once-a-day fentanyl citrate patch (Fentos Tape) could be a new treatment option in patients with end-of-dose failure using a 72-h transdermal fentanyl matrix patch. ( Hirayama, Y; Horiuchi, I; Ishitani, K; Kato, J; Koike, K; Kusakabe, T; Machino, T; Mihara, H; Nagasako, T; Nishisato, T; Terui, T; Yamakage, M, 2016)
"The pharmacokinetics of the sublingual fentanyl orally disintegrating tablet appear to be negatively affected by the presence of salivary gland hypofunction, although the moistening of the oral cavity before dosing results in a pharmacokinetic profile similar to that seen with the giving of pilocarpine hydrochloride."1.43The Influence of Low Salivary Flow Rates on the Absorption of a Sublingual Fentanyl Citrate Formulation for Breakthrough Cancer Pain. ( Buchanan, A; Davies, A; Mundin, G; Vriens, J; Waghorn, M; Webber, K, 2016)
"Breakthrough cancer pain is defined as a transient exacerbation of pain that occurs spontaneously or in response to a trigger, despite stable and controlled background pain."1.42Breakthrough cancer pain: a comparison of surveys with European and Canadian patients. ( Bedard, G; Buchanan, A; Chow, E; Davies, A; Hawley, P; McDonald, R; Popovic, M; Wong, E, 2015)
"Breakthrough pain affects 40%-90% of patients with cancer pain."1.42Use of nasal fentanyl for cancer pain: A pharmacoepidemiological study. ( Borchgrevink, PC; Fredheim, OM; Mahic, M; Skurtveit, S, 2015)
" Differences exist between TIRFs regarding formulation design and dosing to treat BTCP."1.42Transmucosal Immediate-Release Fentanyl for Breakthrough Cancer Pain: Opportunities and Challenges for Use in Palliative Care. ( Atayee, RS; Chang, A; Ma, JD; Revta, C; Roeland, EJ, 2015)
"IV-PCA provided timely, safe and useful analgesia for patients with severe breakthrough pain and may be useful to help titration of opioids, weaning to oral analgesia and to decide for interventional procedures."1.40Safety profile of intravenous patient-controlled analgesia for breakthrough pain in cancer patients: a case series study. ( Ashmawi, HA; Cascudo, GM; de Santana Neto, J; Guimaraes, GM; Neto, JO; Sousa, AM, 2014)
"Pain is a symptom of cancer and is categorized in two forms: background pain to be treated with analgesics, and breakthrough cancer pain (BTcP), which needs drug treatment on demand."1.40Cost-effectiveness analysis of transnasal fentanyl citrate for the treatment of breakthrough cancer pain. ( Oradei, M; Ruggeri, M; Turriziani, A, 2014)
" Dosing proportional to basic opioid regimen is now proposed as an alternative to dose titration."1.39Treatment of breakthrough cancer pain: to titrate or to proportionate? ( Hans, GH, 2013)
"Uncontrolled prescription for non-cancer pain must be criticized due to the problem of addiction."1.39[Rapid release fentanyl administration forms. Comments of the Working Group on Tumor Pain of the German Pain Society]. ( Heuser-Grannemann, E; Junker, U; Schenk, M; Wiese, CH; Wirz, S; Zimmermann, M, 2013)
"FPNS is indicated for the treatment of breakthrough pain in cancer patients who are tolerant to opioid therapy for their underlying persistent cancer pain."1.38Fentanyl pectin nasal spray for breakthrough cancer pain. ( Gabrail, N; Taylor, DR, 2012)

Research

Studies (162)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's142 (87.65)24.3611
2020's20 (12.35)2.80

Authors

AuthorsStudies
Rodríguez, AT1
Viejo, MN1
Maradey, P1
Canal-Sotelo, J1
Mancilla, PG1
Rivero, SG1
Casillas, IR1
Abián, MH1
Bermudo, CL1
Cascella, M1
Monaco, F1
Nocerino, D1
Chinè, E1
Carpenedo, R1
Picerno, P1
Migliaccio, L1
Armignacco, A1
Franceschini, G2
Coluccia, S1
Gennaro, PD1
Tracey, MC1
Forte, CA1
Tafuri, M1
Crispo, A1
Cutugno, F1
Vittori, A1
Natoli, S2
Cuomo, A6
Kwon, MY2
Lee, MY1
Han, YJ1
Lee, SH1
Kim, EJ1
Park, S1
Lee, YG2
Koo, DH2
Mercadante, S22
Caraceni, A2
Mammucari, M2
Marchetti, P3
Mediati, RD1
Tonini, G1
Thantiprechapong, T1
Tilagul, T1
Vasikasin, V1
Lange, EMS1
Kim, J1
Klumpner, TT1
McCarthy, RJ1
Wong, CA1
Thakkar, K1
Toledo, P1
Kaplan, S1
Bergamasco, A1
Sergerie, M1
Castilloux, AM1
Moride, Y1
Bossi, P3
Ghiani, M1
Argenone, A1
Depenni, R1
Norman, C1
Maynard, L1
Lee, A1
Landau, R1
Lavin, T1
Goodman, S1
Menon, P1
Smiley, R1
Camps Herrero, C1
Batista, N1
Díaz Fernández, N1
Escobar Álvarez, Y1
Gonzalo Gómez, A1
Isla Casado, D1
Salud, A1
Terrasa Pons, J1
Guillem Porta, V1
Løhre, ET1
Thronæs, M2
Klepstad, P1
Ghafoor, I1
Siddiqui, A1
Hafeez, H1
Usman, HM1
Arrieta Loitegui, M1
Caro Teller, JM1
Rosas Espinoza, C1
Ferrari Piquero, JM1
Chiou, TJ1
Chao, TC1
Chao, TY1
Huang, JS1
Chang, YF1
Wang, CH1
Amezcua, V1
Doello, K1
González-Callejas, D1
Satomi, M1
Kono, T1
Giuliani, J1
Fiorica, F1
Sacchetto, A1
Vaccari, F1
Bonetti, A1
Hashemi, M1
Zali, A1
Golmakani, E1
Delshad, MH1
Shadnoush, M1
Akbari, ME1
Valtola, A1
Laakso, M1
Hakomäki, H1
Anderson, BJ1
Kokki, H1
Ranta, VP1
Rinne, V1
Kokki, M1
Jamieson, L2
Harrop, E2
Johnson, M1
Liossi, C1
Mott, C1
Oulton, K1
Skene, SS1
Wong, IC1
Howard, RF1
Schug, SA2
Ting, S1
Yomiya, K3
Kaneshima, M1
Kyosaka, B1
Warita, E1
Hosonuma, R1
Osato, S1
Brant, JM1
Rodgers, BB1
Gallagher, E1
Sundaramurthi, T1
Cortesi, PA2
D'Angiolella, LS1
Vellucci, R3
Allegri, M1
Casale, G2
Favaretti, C1
Kheiraoui, F1
Cesana, G1
Mantovani, LG1
Guitart, J5
Vargas, MI4
De Sanctis, V5
Folch, J5
Salazar, R5
Fuentes, J5
Coma, J5
Ferreras, J5
Moya, J6
Tomás, A5
Estivill, P4
Rodelas, F5
Jiménez, AJ4
Sanz, A3
Choy, TH1
Ho, WHP1
Wong, ICK1
Masel, EK1
Landthaler, R1
Gneist, M1
Watzke, HH1
Prieto, I1
Pardo, J2
Luna, J1
Marin, JP1
Olivera, J1
Garcia, AJ1
Perez, AM1
Breivik, H1
Husic, S1
Imamovic, S1
Matic, S1
Sukalo, A1
Coombes, L1
Burke, K1
Anderson, AK1
Überall, MA1
Lux, EA1
Schwittay, A1
Kleeberg, UR3
Papke, J1
Yen, TY1
Chiou, JF1
Chiang, WY1
Su, WH1
Huang, MY1
Hu, MH1
Wu, SC1
Lai, YL1
Michenot, N1
Rostaing, S1
Baron, L1
Faure, S1
Jovenin, N1
Hubault, P1
Delorme, T1
Collin, E1
Filbet, M1
Chvetzoff, G1
Delorme, C1
Minello, C1
Magnet, M1
Ammar, D1
Krakowski, I1
Poulain, P3
Yousef, AA1
Alzeftawy, AE1
Magnani, C1
Giannarelli, D1
Calvieri, A1
Dardeli, A1
Eusepi, G1
Restuccia, MR1
Mastroianni, C1
Adile, C8
Masedu, F2
Costanzi, A2
Aielli, F7
Gunnellini, M1
Rollman, JE1
Heyward, J1
Olson, L1
Lurie, P1
Sharfstein, J1
Alexander, GC1
Santeufemia, DA1
Miolo, G1
Brząkała, J1
Leppert, W1
Alarcón, MDL1
Estévez, FV1
Cabezón-Gutiérrez, L1
Padrós, MC1
Martín-Arroyo, JMT1
Rebollo, MA1
Jiménez-López, AJ1
Sanz-Yagüe, A1
Mena, A1
Jiménez, E1
Aymar, N1
Ortiz, I1
Roncero, R1
Mestre, F1
Vidal, M1
Triarico, S1
Capozza, MA1
Mastrangelo, S1
Attinà, G1
Maurizi, P1
Ruggiero, A1
Diez-Picazo, LD1
Guasch, E1
Brogly, N1
Gilsanz, F1
Fidkowski, CW1
Shah, S1
Alsaden, MR1
Valenti, M1
Handsaker, S2
Dempsey, L2
Fabby, C2
Grassin-Delyle, S1
Naline, E1
Devillier, P1
Perelman, M3
Leake, S1
Dietrich, E2
Gums, JG2
Zeppetella, G5
Porzio, G3
Averna, L1
Ficorella, C1
Casuccio, A10
Elsner, F2
Pastrana, T1
Plock, N1
Facius, A2
Hartmann, L1
Baumann, S1
Nave, R2
McWilliams, K1
Fallon, M1
Bornemann-Cimenti, H2
Wejbora, M2
Szilagyi, IS2
Sandner-Kiesling, A2
Kuo, KL1
Saokaew, S1
Stenehjem, DD1
Meissner, W1
Sabatowski, R1
Beutlhauser, T1
Oeltjenbruns, J1
Schäfer, M1
Sláma, O1
Webster, LR1
Slevin, KA1
Narayana, A2
Earl, CQ1
Yang, R2
Prestia, G2
Vargas, I1
Vázquez, JM1
Ribera, H1
Arilla, M1
Aberasturi, T1
Sintes, D1
Lombán, E1
Hans, GH1
Ketterer, W1
Kosugi, T1
Hamada, S1
Takigawa, C2
Shinozaki, K1
Kunikane, H1
Goto, F2
Tanda, S2
Shima, Y2
Matoba, M2
Adachi, I2
Yoshimoto, T2
Eguchi, K2
Taylor, D2
Radbruch, L2
Revnic, J2
Torres, LM3
Ellershaw, JE2
Davies, AN2
Sousa, AM1
de Santana Neto, J1
Guimaraes, GM1
Cascudo, GM1
Neto, JO1
Ashmawi, HA1
Velázquez Rivera, I1
Muñoz Garrido, JC1
García Velasco, P1
España Ximénez de Enciso, I1
Velázquez Clavarana, L1
Novotna, S1
Valentova, K1
Fricova, J1
Richterova, E1
Harabisova, S1
Bullier, F1
Trinquet, F2
Kongsgaard, UE1
Eeg, M2
Greisen, H1
England, R1
Maddocks, M1
Manderson, C1
Zadora-Chrzastowska, S1
Wilcock, A1
Jandhyala, R3
Fullarton, J1
Passik, SD2
Ruggeri, M1
Turriziani, A1
Oradei, M1
Davis, MP4
Bruera, E1
Fullarton, JR2
Bennett, MI2
Shimoyama, N2
Gomyo, I2
Katakami, N1
Okada, M1
Yukitoshi, N2
Ohta, E2
Shimoyama, M2
Granata, R2
Bertulli, R1
Saita, L1
Locati, L1
Bergamini, C1
Mirabile, A1
Imbimbo, M1
Resteghini, C1
Licitra, L1
Zucco, F1
Bonezzi, C1
Fornasari, D1
Gombert-Handoko, KB1
Rauck, R2
Parikh, N3
Dillaha, L1
Barker, J1
Stearns, L1
Davies, A4
Jarosz, J2
O'Brien, T2
Schneid, H2
Kress, HG2
Bedard, G1
McDonald, R1
Hawley, P1
Buchanan, A2
Popovic, M1
Wong, E1
Chow, E1
Chen, C1
Gupta, A1
Cortegiani, A2
Valle, A1
Villari, P1
Teramoto, O1
Kojima, K1
Higuchi, H1
Caruselli, A1
Meli, MR1
Bellavia, G1
Tuttolomondo, A1
Doulton, B1
Popper, L1
Jaatun, E1
Kvitberg, M1
Kaasa, S1
Cánovas-Martínez, L1
Carceller-Ruiz, JJ1
Díaz-Parada, P1
Illodo-Miramontes, G1
Freire-Vila, E1
De la Iglesia-López, A1
Iglesias, BG1
López-Ulloa, B1
Domínguez-Suárez, E1
Camba-Rodríguez, A1
Fredheim, OM1
Mahic, M1
Skurtveit, S1
Borchgrevink, PC1
Trinidad, JM1
Calderón, E1
Benitez, D1
De Franceschi, L1
Mura, P1
Schweiger, V1
Vencato, E1
Quaglia, FM1
Delmonte, L1
Evangelista, M1
Polati, E1
Olivieri, O1
Finco, G1
Koike, K1
Terui, T1
Nagasako, T1
Horiuchi, I1
Machino, T1
Kusakabe, T1
Hirayama, Y1
Mihara, H1
Yamakage, M1
Kato, J1
Nishisato, T1
Ishitani, K1
Chang, A1
Roeland, EJ1
Atayee, RS1
Revta, C1
Ma, JD1
Rogríguez, D1
Urrutia, G1
Escobar, Y2
Murillo, M1
Mundin, G1
Vriens, J1
Webber, K1
Waghorn, M1
Minkowitz, H1
Bull, J1
Brownlow, RC1
Tshibuyl, PN1
Olang, PO1
Ogutu, O1
Chokwe, TM1
Garnock-Jones, KP1
Alberts, DS1
Smith, CC1
Rauck, RL2
Meijler, WJ1
Romualdi, P2
Candeletti, S1
Fanelli, G1
Pannuti, R1
Peruselli, C1
Ballantyne, JC1
Marinangeli, F1
Mazzola, R1
Ricchetti, F1
Fiorentino, A1
Giaj-Levra, N1
Fersino, S1
Tebano, U1
Albanese, S1
Gori, S1
Alongi, F1
Dyer, O1
Cho, HN1
Oh, S1
Lee, SS1
Messina, J1
Golsorkhi, A1
Xie, F2
Sima, L1
Fang, WX1
Wu, XM1
Li, F1
Gatti, A2
Luis Lerzo, G1
Ferrera, P1
Kessler, J1
Bardenheuer, HJ1
Porta-Sales, J1
Tagarro, I1
Darwish, M1
Núñez-Olarte, JM1
Alvarez-Jiménez, P1
Nalamachu, SR1
Wallace, MS1
Hassman, D1
Howell, J1
Hansen, MS1
Mathiesen, O1
Trautner, S1
Dahl, JB1
Taylor, DR1
Gabrail, N1
Paech, MJ1
Bloor, M1
Lo Presti, C1
Veldhorst-Janssen, NM1
Fiddelers, AA1
Zandstra, H2
Kessels, AG1
Marcus, MA1
Neef, C1
van der Kuy, PH1
Smith, H1
Kaessner, N1
Roepcke, S1
Lahu, G1
Füessl, HS1
Stiefelhagen, P1
Gallagher, R1
Meriggi, F1
Zaniboni, A1
Mañas, A1
Juliá, J1
Gálvez, R1
Zaragozá, F1
Margarit, C1
López, R1
Casas, A1
Antón, A1
Cruz, JJ1
Wirz, S1
Wiese, CH1
Zimmermann, M1
Junker, U1
Heuser-Grannemann, E1
Schenk, M1

Clinical Trials (11)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Quality of Life Study in Patients With Cancer Breakthrough Pain Treated in Palliative Care Units[NCT02840500]101 participants (Actual)Observational2016-06-27Completed
Fentanyl Buccal Soluble Films Feasible Dose Range Study for Breakthrough Pain in Taiwanese Cancer Patients[NCT03669263]36 participants (Actual)Interventional2014-11-25Completed
A Double Blind, Active Controlled Crossover Study to Evaluate the Efficacy and Safety of Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for the Management of Breakthrough Pain in Opioid Tolerant Patients With Chronic Pain[NCT00813488]Phase 3213 participants (Actual)Interventional2008-12-31Completed
Efficacy of Injectable Fentanyl in Sublingual Route Versus Oral Morphine Syrup for Breakthrough Pain in Gynecologic Cancer Patients With Chronic Cancer Pain : A Randomized Double Blind Controlled Trial[NCT05037539]Phase 1/Phase 220 participants (Actual)Interventional2021-06-15Completed
Randomized, Placebo-controlled Study of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer[NCT01842893]Phase 391 participants (Actual)Interventional2011-11-30Completed
Phase III Study of KW-2246 (A Double Blind Study of KW-2246 Compared to Placebo for Breakthrough Pain Episodes in Cancer Patients)[NCT01326689]Phase 342 participants (Actual)Interventional2011-03-31Completed
A Phase III Clinical Study of KW-2246 for Breakthrough Pain in Cancer Patients[NCT00684632]Phase 351 participants (Actual)Interventional2008-03-31Completed
An Observational Study to Assess the Efficacy, Safety, and Tolerability of Abstral Oral Disintegrating Tablet (ODT) for the Management of Breakthrough Cancer Pain in Korean Cancer Patients[NCT03895762]143 participants (Actual)Observational2017-07-04Completed
A Dose Titrated Clinical Trial With a Placebo-controlled, Double-blind, Randomised, Cross-over Phase to Demonstrate the Efficacy of 400 μg Intranasal Fentanyl (INFS) Dose Strength, and to Evaluate 12 Weeks Safety and Nasal Tolerability of All Dose Strengt[NCT01429051]Phase 346 participants (Actual)Interventional2011-08-31Completed
A Randomized, Double-blind, Placebo-controlled Multi-center Study to Evaluate the Safety and Efficacy of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain[NCT00538850]Phase 3130 participants (Actual)Interventional2007-10-31Completed
A Prospective Study Comparing the Efficacy and Safety of 100 mcg and 200 mcg of Intranasal Fentanyl Pectin Spray as an Analgesic in Adult Males Undergoing Outpatient Cystoscopic Procedures[NCT01756651]Phase 120 participants (Actual)Interventional2013-02-28Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Clinician Global Impression of Change (CGIC) at Visit 8- 2 Months After Open Label Treatment

"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. Here it was assessed 2 months after the start of the open-label extension period.~The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination)." (NCT00813488)
Timeframe: Two months after start of open-label extension period

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)1.4
Standard of Care (SOC)0.7

Clinician Global Impression of Change (CGIC) at Visit 9- 3 Months After Open Label Treatment

"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination), which correspond to 1, 2, or 3 months after the start of the open-label extension period." (NCT00813488)
Timeframe: 3 months after start of open-label extension period

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)1.6
Standard of Care (SOC)0.7

Clinician Global Impression of Change (CGIC)Endpoint

"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination)." (NCT00813488)
Timeframe: End of open-label extension period

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)1.4
Standard of Care (SOC)0.7

Clinician Global Impression of Change at Visit 7- 1 Month After Open Label Treatment

"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination) which correspond to 1, 2, or 3 months after the start of the open-label extension period." (NCT00813488)
Timeframe: One month after start of open-label extension

InterventionUnit on a scale (Mean)
Fentanyl Buccal Tablet (FBT)1.4
Standard of Care (SOC)0.6

Pain Intensity Difference (PID) at 10 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 10 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: Immediately pre-dose and 10 minutes after dosing

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablet (FBT).35
Immediate-release Oxycodone (OXY).29

Pain Intensity Difference (PID) at 15 Minutes Post-treatment (PID15)

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: Immediately pre-dose and 15 minutes after dosing

InterventionUnits on scale (Least Squares Mean)
Fentanyl Buccal Tablet (FBT)0.88
Immediate-release Oxycodone (OXY)0.76

Pain Intensity Difference (PID) at 30 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 30 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: Immediately pre-dose and 30 minutes after dosing

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablet (FBT)2.10
Immediate-release Oxycodone (OXY)1.79

Pain Intensity Difference (PID) at 45 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 45 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: Immediately pre-dose and 45 minutes after dosing

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablet (FBT)3.13
Immediate-release Oxycodone (OXY)2.85

Pain Intensity Difference (PID) at 5 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 5 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: Immediately pre-dose and 5 minutes after dosing

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablet (FBT).08
Immediate-release Oxycodone (OXY).06

Pain Intensity Difference (PID) at 60 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 60 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: Immediately pre-dose and 60 minutes after dosing

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablet (FBT)3.65
Immediate-release Oxycodone (OXY)3.48

Pain Relief (PR) Score at 5 Minutes Post-treatment

The PR score 5 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00813488)
Timeframe: 5 minutes after treatment

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)0.11
Immediate-release Oxycodone (OXY)0.10

Pain Relief Score at 10 Minutes Post-treatment

The PR score 10 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00813488)
Timeframe: 10 minutes after treatment with study drug

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)0.32
Immediate-release Oxycodone (OXY)0.26

Pain Relief Score at 15 Minutes Post-treatment

The PR score 15 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00813488)
Timeframe: 15 minutes after treatment with study drug

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)0.68
Immediate-release Oxycodone (OXY)0.56

Pain Relief Score at 30 Minutes Post-treatment

The PR score 30 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00813488)
Timeframe: 30 minutes after treatment with study drug

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)1.48
Immediate-release Oxycodone (OXY)1.22

Pain Relief Score at 45 Minutes Post-treatment

The PR score 45 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00813488)
Timeframe: 45 minutes after treatment with study drug

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)2.14
Immediate-release Oxycodone (OXY)1.90

Pain Relief Score at 60 Minutes Post-treatment

The PR score 60 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00813488)
Timeframe: 60 minutes after treatment with study drug

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)2.44
Immediate-release Oxycodone (OXY)2.27

Patient Global Impression of Change (PGIC) at Visit 7- 1 Month After Open Label Treatment

The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. This was assessed 1 month after start of the open-label extension period. (NCT00813488)
Timeframe: One month after start of open-label treatment

InterventionUnit on a scale (Mean)
Fentanyl Buccal Tablet (FBT)1.5
Standard of Care (SOC)0.6

Patient Global Impression of Change (PGIC) at Visit 8- 2 Months After Open Label Treatment

The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 2 months after the start of the open-label extension period. (NCT00813488)
Timeframe: 2 months after start of open-label extension period

InterventionUnits on scale (Mean)
Fentanyl Buccal Tablet (FBT)1.5
Standard of Care (SOC)0.8

Patient Global Impression of Change (PGIC) at Visit 9- 3 Months After Open Label Treatment

The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 3 months after the start of the open-label extension period. (NCT00813488)
Timeframe: 3 months after start of open-label extension period

InterventionUnits on scale (Mean)
Fentanyl Buccal Tablet (FBT)1.7
Standard of Care (SOC)0.8

Patient Global Impression of Change (PGIC) Endpoint

The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed at the conclusion of the open-label extension period. (NCT00813488)
Timeframe: At conclusion of open-label extension period

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)1.5
Standard of Care (SOC)0.9

Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)

The PR score at set intervals after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). The maximum TOTPAR score that could be achieved at 60 minutes is equal to 16; thus, %TOTPAR at 60 minutes is (TOTPAR60 /16) x 100.The % TOTPAR achieved 60 minutes after the administration of study drug was calculated during the double-blind treatment phase. (NCT00813488)
Timeframe: From 5 minutes through 60 minutes after study drug treatment

InterventionPercentage change (Mean)
Fentanyl Buccal Tablet (FBT)40.11
Immediate-release Oxycodone (OXY)35.59

Percentage Change in Pain Intensity Difference (% PID) at 10 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID10 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 10 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. This was assessed during the double-blind treatment period. (NCT00813488)
Timeframe: Immediately before treatment and 10 minutes after treatment.

InterventionPercentage change (Mean)
Fentanyl Buccal Tablet (FBT)4.83
Immediate-release Oxycodone (OXY)3.89

Percentage Change in Pain Intensity Difference (% PID) at 15 Minutes Post-treatment

Pain intensity (PI) scores were assessed during the double-blind treatment period on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. (NCT00813488)
Timeframe: Baseline (immediately pre-dose) and 15 minutes after dosing

InterventionPercentage change (Mean)
Fentanyl Buccal Tablet (FBT)12.38
Immediate-release Oxycodone (OXY)10.38

Percentage Change in Pain Intensity Difference (% PID) at 30 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 30 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. (NCT00813488)
Timeframe: Pre-dose and 30 minutes after dosing

InterventionPercentage change (Mean)
Fentanyl Buccal Tablet (FBT)29.72
Immediate-release Oxycodone (OXY)25.03

Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 45 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. (NCT00813488)
Timeframe: Immediately pre-dose and 45 minutes after dosing

InterventionPercentage change (Mean)
Fentanyl Buccal Tablet (FBT)44.84
Immediate-release Oxycodone (OXY)40.49

Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 5 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. (NCT00813488)
Timeframe: Immediately pre-dose and 5 minutes after dosing

InterventionPercentage change (Mean)
Fentanyl Buccal Tablet (FBT)1.01
Immediate-release Oxycodone (OXY)0.73

Percentage Change in Pain Intensity Difference (% PID) at 60 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 60 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. (NCT00813488)
Timeframe: Immediately pre-dose and 60 minutes after dosing

InterventionPercentage change (Mean)
Fentanyl Buccal Tablet (FBT)52.61
Immediate-release Oxycodone (OXY)49.47

Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)

PI scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. SPID30 were derived from PID values. The SPID30 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 30 minutes,after the administration of study drug. SPID30 = (⅓ x PID5) + (⅓ x PID10) + (⅓ x PID15) + PID30. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: From 5 minutes after dosing through 30 minutes after dosing

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablet (FBT)2.54
Immediate-release Oxycodone (OXY)2.16

Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)

"PI scores were assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine during the double-blind treatment period. The SPID60 was derived from PID values. The SPID60 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 60 minutes,after the administration of the study drug.~SPID60 = SPID30 + PID45 + PID60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry." (NCT00813488)
Timeframe: From 5 minutes after dosing through 60 minutes after dosing

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablet (FBT)9.32
Immediate-release Oxycodone (OXY)8.50

Time to Any Pain Relief (APR) by Treatment - <= 5 Minutes

Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 5 minutes or less was compared. (NCT00813488)
Timeframe: From time study drug was taken until 5 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)55
Immediate-release Oxycodone (OXY)50

Time to Any Pain Relief (APR) by Treatment <=10 Minutes

Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 10 minutes or less was compared. (NCT00813488)
Timeframe: From study drug treatment until 10 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)226
Immediate-release Oxycodone (OXY)219

Time to Any Pain Relief (APR) by Treatment <=15 Minutes

Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 15 minutes or less was compared. (NCT00813488)
Timeframe: From study drug administration to 15 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)515
Immediate-release Oxycodone (OXY)451

Time to Any Pain Relief (APR) by Treatment <=30 Minutes

Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 30 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug administration till 30 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)1004
Immediate-release Oxycodone (OXY)877

Time to Any Pain Relief (APR) by Treatment <=45 Minutes

Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 45 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug treatment until 45 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)1217
Immediate-release Oxycodone (OXY)1150

Time to Any Pain Relief (APR) by Treatment <=60 Minutes

Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 60 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug treatment until 60 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)1271
Immediate-release Oxycodone (OXY)1239

Time to Meaningful Pain Relief (MPR) by Treatment - <= 5 Minutes

Time to MPR (subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. (NCT00813488)
Timeframe: From time study drug was taken until 5 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)21
Immediate-release Oxycodone (OXY)26

Time to Meaningful Pain Relief (MPR) by Treatment <=10 Minutes

Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 10 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug treatment until 10 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)88
Immediate-release Oxycodone (OXY)91

Time to Meaningful Pain Relief (MPR) by Treatment <=15 Minutes

Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 15 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug administration until 15 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)230
Immediate-release Oxycodone (OXY)212

Time to Meaningful Pain Relief (MPR) by Treatment <=30 Minutes

Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 30 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug administration until 30 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)613
Immediate-release Oxycodone (OXY)503

Time to Meaningful Pain Relief (MPR) by Treatment <=45 Minutes

Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 45 minutes or less was compared. (NCT00813488)
Timeframe: From study drug administration until 45 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)983
Immediate-release Oxycodone (OXY)864

Time to Meaningful Pain Relief (MPR) by Treatment <=60 Minutes

Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 60 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug administration until 60 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)1139
Immediate-release Oxycodone (OXY)1047

Total Pain Relief at 60 Minutes (TOTPAR60)

"The mean TOTPAR at 60 minutes will be calculated for each episode as the weighted sum of Pain Relief (PR) scores (5-point Likert scale, 0 = none to 4 = complete) at each assessment of PR (during the double-blind treatment period) until 60 minutes after study drug administration, as follows:~TOTPAR60 =(⅓ x PR5)+ (⅓ x PR10) +(⅓ x PR15)+ PR30 + PR45 + PR60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry." (NCT00813488)
Timeframe: From 5 minutes to 60 minutes after dosing

Interventionunits on a scale (Least Squares Mean)
Fentanyl Buccal Tablet (FBT)6.43
Immediate-release Oxycodone (OXY)5.70

Use of Standard Rescue Medication

Any use of standard rescue medication after the administration of study drug for relief of Breakthrough Pain (BTP) during the double-blind treatment phase was recorded in the patient's diary. The number of breakthrough pain episodes for which study drug treatment was administered and which required rescue medication use was recorded. (NCT00813488)
Timeframe: Throughout the double-blind treatment period

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)39
Immediate-release Oxycodone (OXY)41

Breakthrough Pain Preference Questionnaire

The BTP preference questionnaire is a questionnaire used to measure patients' preference for FBT or immediate-release oxycodone for management of BTP. The question is used to determine a patient's preference between the study drugs given in the 2 double-blind treatment periods. The patient was asked to select 1 of the following: 1, a preference for study drug used in the 1st double-blind treatment period; 2, a preference for study drug used in the 2nd double-blind treatment period; or 3, no preference. (NCT00813488)
Timeframe: At Visit 6 ( up to 42 days depending upon how long it takes the patient to manage their BTP) after completion of both double-blind treatment periods.

InterventionParticipants (Number)
Preferred FBTPreferred OxycodoneNo PreferenceMissing
Total62462312

Medication Performance Assessment 30 Minutes Post-treatment

"The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 30 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient's paper diary. Patients were asked How well did your study medication perform in controlling this breakthrough pain episode? The number of episodes rated for each category were recorded." (NCT00813488)
Timeframe: 30 minutes post-treatment

,
InterventionEpisodes (Number)
ExcellentVery GoodGoodFairPoorNo Response
Fentanyl Buccal Tablet (FBT)4912537841634133
Immediate-release Oxycodone (OXY)1610430439148930

Medication Performance Assessment 60 Minutes Post-treatment

"The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 60 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient's paper diary. Patients were asked How well did your study medication perform in controlling this breakthrough pain episode? The number of episodes rated for each category were recorded." (NCT00813488)
Timeframe: 60 minutes post-treatment

,
InterventionEpisodes (Number)
ExcellentVery GoodGoodFairPoorNo Response
Fentanyl Buccal Tablet (FBT)1603715081819230
Immediate-release Oxycodone (OXY)11931356517913622

Efficacy Phase: General Impression (GI) Score at 60 Minutes After First Dose

"Participants assessed their general impression (GI) of treatment efficacy for treated BTP episodes at 60 minutes after first dose of study drug. The validated, categorical 5-point Verbal Rating Scale (VRS) was used for this assessment and scored as follows:~0 =poor;~1 =fair;~2 =good;~3 =very good;~4 =excellent." (NCT01429051)
Timeframe: During the efficacy phase (II), at each episode of breakthrough pain, 60 minutes after first dose of study drug.

Interventionunits on a scale (Least Squares Mean)
Intranasal Fentanyl Spray (INFS)1.9
Placebo1.1

Induction Phase: Pain Intensity Difference at 10 Minutes (PID10) After Treatment

"During the efficacy phase participants assessed their pain intensity at each breakthrough pain (BTP) episode at 0 and 10 minutes after first dose using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain. PID10 is calculated as the difference in pain intensity from time 0 to 10 minutes. A positive value is a decrease (improvement) of the pain; a ≥ 2-point difference is considered as clinically important." (NCT01429051)
Timeframe: During the efficacy phase (II), at each episode of breakthrough pain, at 0 and 10 minutes after first dose of study drug.

Interventionunits on a scale (Least Squares Mean)
Intranasal Fentanyl Spray (INFS)2.5
Placebo1.4

Efficacy Phase: Pain Intensity Difference (PID) at 5, 30, and 60 Minutes After First Dose of Study Drug

"During the efficacy phase participants assessed their pain intensity at each breakthrough pain (BTP) episode at 0, 5, 30 and 60 minutes after first dose using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain. PID is calculated as the difference in pain intensity from time 0 to each time point. A positive value is a decrease (improvement) of the pain; a ≥ 2-point difference is considered as clinically important." (NCT01429051)
Timeframe: During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug.

,
Interventionunits on a scale (Least Squares Mean)
PID at 5 minutesPID at 30 minutesPID at 60 minutes
Intranasal Fentanyl Spray (INFS)1.33.03.3
Placebo0.81.82.2

Efficacy Phase: Proportion of BTP Episodes With a Positive Response Defined as a ≥ 1, 2 or 3 Point Reduction in Pain Intensity

"Overall responder rate is defined as the proportion of breakthrough pain (BTP) episodes with a positive response to treatment. The following definitions of a positive response were analyzed: • greater than or equal to 1 point reduction in pain intensity (PI) from time 0, • greater than or equal to 2 point reduction in PI from time 0, and • greater than or equal to 3 point reduction in PI from time 0. Pain intensity was assessed using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain." (NCT01429051)
Timeframe: During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug

,
Interventionproportion of breakthrough pain episodes (Number)
≥ 1 point reduction in PI at 5 minutes≥ 1 point reduction in PI at 10 minutes≥ 1 point reduction in PI at 30 minutes≥ 1 point reduction in PI at 60 minutes≥ 2 point reduction in PI at 5 minutes≥ 2 point reduction in PI at 10 minutes≥ 2 point reduction in PI at 30 minutes≥ 2 point reduction in PI at 60 minutes≥ 3 point reduction in PI at 5 minutes≥ 3 point reduction in PI at 10 minutes≥ 3 point reduction in PI at 30 minutes≥ 3 point reduction in PI at 60 minutes
Intranasal Fentanyl Spray (INFS)0.610.740.810.860.330.510.600.650.180.320.450.50
Placebo0.450.550.660.690.240.310.410.480.170.240.340.48

Efficacy Phase: Proportion of BTP Episodes With a Positive Response Defined as a ≥ 33% or 50% Reduction in Pain Intensity

"Overall responder rate is defined as the proportion of breakthrough pain (BTP) episodes with a positive response to treatment. The following definitions of a positive response were analyzed: • Greater than 33% reduction in PI from time 0; • Greater than or equal to 50% reduction in PI from time 0. Pain intensity was assessed using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain." (NCT01429051)
Timeframe: During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug

,
Interventionproportion of breakthrough pain episodes (Number)
> 33% reduction in PI at 5 minutes> 33% reduction in PI at 10 minutes> 33% reduction in PI at 30 minutes> 33% reduction in PI at 60 minutes≥ 50% reduction in PI at 5 minutes≥ 50% reduction in PI at 10 minutes≥ 50% reduction in PI at 30 minutes≥ 50% reduction in PI at 60 minutes
Intranasal Fentanyl Spray (INFS)0.230.440.550.580.110.310.490.52
Placebo0.170.240.340.480.070.210.310.34

Efficacy Phase: Sum of Pain Intensity Differences (SPID0-60 and SPID0-30) Derived From PI Scores

"The SPID30 and SPID60 represent the average improvement in pain intensity over the 30 minute interval and 60 minute interval, respectively. SPIDt was calculated as the area under the curve (AUC) for Pain Intensity Difference over the time interval 0 to t minutes, respectively, divided by the length of the time interval (t minutes). A positive value is a decrease (improvement) of the pain.~Pain intensity was assessed at 0, 5, 30 and 60 minutes after study drug using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain. PID is calculated as the difference in pain intensity from time 0 to each time point." (NCT01429051)
Timeframe: During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug

,
Interventionunits on a scale (Least Squares Mean)
SPID30SPID60
Intranasal Fentanyl Spray (INFS)0.60.7
Placebo0.40.5

Incidence of Improvement or Worsening in Nasal Mucosa Sign or Abnormality Score

Medical examination of the nasal cavity by rhinoscopy was performed by an oto-rhino-laryngologist before the start of study treatment and at 12 weeks. Signs and any abnormalities were observed for each nostril using the following 4 points assessment scale: • 0 =not present; • 1 =present in a mild degree; • 2 =present in a moderate degree; • 3 =present in a severe degree. A difference in score of 1 or more from Baseline to the end of treatment represented a worsening, while a negative value indicated an improvement of the observed clinical sign. The oto-rhino-laryngologist also assessed whether worsening of a sign was related to study drug. Assessments for both left and right nostrils are presented together. The incidence is calculated as the number of assessments (n) in the improvement or worsening category divided by the number of assessments with a non-missing score for the Nasal Mucosa or Abnormality assessment. Only those signs or abnormalities with n>0 were included (NCT01429051)
Timeframe: Baseline and at 12 weeks

Interventionproportion of nostril assessments (Number)
Change of color: ImprovementChange of color: WorseningChange of color: Worsening related to study drugInflammation: ImprovementInflammation: WorseningInflammation: Worsening related to study drugSore nose: ImprovementSore nose: WorseningSore nose: Worsening related to study drugUlceration: ImprovementUlceration: WorseningUlceration: Worsening related to study drugDry nose: ImprovementDry nose: WorseningDry nose: Worsening related to study drugRunny nose: ImprovementRunny nose: WorseningRunny nose: Worsening related to study drugStuffed nose: ImprovementStuffed nose: WorseningStuffed nose: Worsening related to study drugOedema: ImprovementOedema: WorseningOedema: Worsening related to study drugEpistaxis: ImprovementEpistaxis: WorseningEpistaxis: Worsening related to study drug
Intranasal Fentanyl Spray (INFS)0.060.090.090.040.070.070.040.040.04NA0.040.040.090.06NA0.040.130.100.060.170.080.040.170.080.020.020.02

Number of Participants With Adverse Events (AEs)

The severity (intensity of each AE was assessed as mild (transient symptoms, no interference with daily activities), moderate (marked symptoms, moderate interference with daily activities), or severe (considerable interference with daily activities) by the investigator. Serious adverse events are defined as any untoward medical occurrence that at any dose results in death or is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect. The investigator assessed each AE as either related or not related to study treatment. (NCT01429051)
Timeframe: 12 weeks

,,
Interventionparticipants (Number)
Any AEAny AE reported as related to treatmentNon-serious adverse eventsSerious adverse eventsDeathsSevere adverse eventsAEs leading to withdrawalAEs possibly associated with nasal intolerabilityAEs with an onset within 30 minutes of first dose
Efficacy Phase645212203
Titration Phase2314222222211
Tolerability Phase22617857365

Summed Pain Intensity Differences (SPID) at 30 Minutes After Dosing (SPID30)

"Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented no pain and 100 represented worst possible pain at 0 (baseline, beginning of the pain episode), 5, 10, 15, and 30 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID30 was calculated as the time-weighted sum of the PID scores using the following formula: SPID30=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30). The minimum and maximum SPID30 scores were -3000 and 3000. A higher score indicates less pain." (NCT00538850)
Timeframe: Baseline (time 0, beginning of each pain episode) through 30 minutes after dosing for each pain episode

InterventionUnits on a scale (Mean)
Fentanyl Sublingual Spray640.3
Placebo399.6

Global Evaluation of the Study Medication at 30 and 60 Minutes After Dosing

Global evaluation of the study medication was assessed by the participant on a 5-point scale (1=Poor, 2=Fair, 3=Good, 4=Very good, 5=Excellent) at 30 and 60 minutes after each dose of study medication during each breakthrough pain episode. A higher score indicates a better evaluation. (NCT00538850)
Timeframe: 30 through 60 minutes after dosing for each pain episode

,
InterventionUnits on a scale (Mean)
30 minutes60 minutes
Fentanyl Sublingual Spray2.83.1
Placebo2.02.2

Summed Pain Intensity Differences (SPID) at 5, 10, 15, 45, and 60 Minutes After Dosing

"Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented no pain and 100 represented worst possible pain at 0 (baseline, beginning of the pain episode), 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID was calculated as the time-weighted sum of the PID scores using the following formulas: SPID5=(5*PID5), SPID10=(5*PID5)+(5*PID10), SPID15=(5*PID5)+(5*PID10)+(5*PID15), SPID30=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30), SPID45=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30)+(15*PID45), SPID60=(5*PID5)+(5*PID10)+(5*PID15)+(15*PID30) +(15*PID45) +(15*PID60). The minimum and maximum SPID scores were -500 to 500, -1000 to 1000, -1500 to 1500, -3000 to 3000, -4500 to 4500, and -6000 to 6000, respectively. A higher score indicates less pain." (NCT00538850)
Timeframe: Baseline (time 0, beginning of each pain episode) through 60 minutes after dosing for each pain episode

,
InterventionUnits on a scale (Mean)
SPID5SPID10SPID15SPID45SPID60
Fentanyl Sublingual Spray40.3115.0220.61122.01649.0
Placebo32.081.1150.3667.0965.7

Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing

Pain relief (PAR) was assessed by the participant on a 5-point scale (1=No relief, 2=A little relief, 3=Moderate relief, 4=A lot of relief, 5=Complete relief) at 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. TOTPAR was calculated as the time-weighted sum of the PAR scores at each time point using the following formulas: TOTPAR5=(5*PAR5), TOTPAR10=(5*PAR5)+(5*PAR10), TOTPAR15=(5*PAR5)+(5*PAR10)+(5*PAR15), TOTPAR30=(5*PAR5)+(5*PAR10)+(5*PAR15)+(15*PAR30), TOTPAR45=(5*PAR5)+(5*PAR10)+(5*PAR15)+(15*PAR30)+(15*PAR45), TOTPAR60=(5*PAR5)+(5*PAR10)+(5*PAR15)+(15*PAR30) +(15*PAR45) +(15*PAR60). The minimum and maximum TOTPAR5, TOTPAR10, TOTPAR15, TOTPAR30, TOTPAR45, and TOTPAR60 scores were 5 to 25, 10 to 50, 15 to 75, 30 to 150, 45 to 225, and 60 to 300, respectively. A higher score indicates more pain relief. (NCT00538850)
Timeframe: 5 through 60 minutes after dosing for each pain episode

,
InterventionUnits on a scale (Mean)
TOTPAR5TOTPAR10TOTPAR15TOTPAR30TOTPAR45TOTPAR60
Fentanyl Sublingual Spray8.619.732.978.3126.3176.4
Placebo7.616.727.161.095.5131.2

Reviews

43 reviews available for fentanyl and Pain, Breakthrough

ArticleYear
Bibliometric Network Analysis on Rapid-Onset Opioids for Breakthrough Cancer Pain Treatment.
    Journal of pain and symptom management, 2022, Volume: 63, Issue:6

    Topics: Analgesics, Opioid; Bibliometrics; Breakthrough Pain; Cancer Pain; Fentanyl; Humans; Neoplasms

2022
Breakthrough cancer pain in the radiotherapy setting: a systematic and critical review.
    Expert review of anticancer therapy, 2023, Volume: 23, Issue:3

    Topics: Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Fentanyl; Head and Neck Neoplasms; Humans; Neopl

2023
Is pain part of a systemic syndrome in head and neck cancer?
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2020, Volume: 28, Issue:2

    Topics: Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Depression; Exercise; Fatigue; Fentanyl; Head an

2020
Breakthrough cancer pain: review and calls to action to improve its management.
    Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 2020, Volume: 22, Issue:8

    Topics: Algorithms; Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Communication; Fentanyl; Humans; Onc

2020
Breakthrough cancer pain in 2020.
    Current opinion in supportive and palliative care, 2020, Volume: 14, Issue:2

    Topics: Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Fentanyl; Humans; Neoplasm Metastasis; Pain Mana

2020
Fentanyl Formulations in the Management of Pain: An Update.
    Drugs, 2017, Volume: 77, Issue:7

    Topics: Analgesia, Patient-Controlled; Analgesics, Opioid; Breakthrough Pain; Drug Administration Routes; Dr

2017
Breakthrough Cancer Pain: A Systematic Review of Pharmacologic Management
.
    Clinical journal of oncology nursing, 2017, 06-01, Volume: 21, Issue:3 Suppl

    Topics: Administration, Oral; Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Education, Nursing, Contin

2017
Non pharmacological interventions and non-fentanyl pharmacological treatments for breakthrough cancer pain: A systematic and critical review.
    Critical reviews in oncology/hematology, 2018, Volume: 122

    Topics: Administration, Oral; Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Double-Blind Method; Fenta

2018
Episodic Breathlessness in Patients with Advanced Cancer: Characteristics and Management.
    Drugs, 2018, Volume: 78, Issue:5

    Topics: Analgesics, Opioid; Breakthrough Pain; Dyspnea; Fentanyl; Humans; Morphine; Neoplasms; Pain Manageme

2018
Treating breakthrough pain in oncology.
    Expert review of anticancer therapy, 2018, Volume: 18, Issue:5

    Topics: Administration, Buccal; Administration, Oral; Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Do

2018
[Opioid switch and change of route of administration in cancer patients treated by morphine].
    Bulletin du cancer, 2018, Volume: 105, Issue:11

    Topics: Administration, Oral; Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Drug Substitution; Fentany

2018
The role of rapid onset fentanyl products in the management of breakthrough pain in cancer patients.
    Pharmacological reports : PR, 2019, Volume: 71, Issue:3

    Topics: Analgesia; Analgesics, Opioid; Breakthrough Pain; Fentanyl; Humans; Neoplasms; Pain Measurement; Qua

2019
Intranasal therapy with opioids for children and adolescents with cancer: results from clinical studies.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2019, Volume: 27, Issue:10

    Topics: Administration, Intranasal; Adolescent; Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Child; D

2019
Fast-acting fentanyl preparations and pain management.
    QJM : monthly journal of the Association of Physicians, 2013, Volume: 106, Issue:10

    Topics: Analgesics, Opioid; Breakthrough Pain; Drug Dosage Calculations; Fentanyl; Humans; Neoplasms; Pain M

2013
Fentanyl for the treatment of tumor-related breakthrough pain.
    Deutsches Arzteblatt international, 2013, Volume: 110, Issue:16

    Topics: Analgesics, Opioid; Breakthrough Pain; Evidence-Based Medicine; Fentanyl; Humans; Neoplasms; Pain Me

2013
The pharmacoeconomics of breakthrough cancer pain.
    Journal of pain & palliative care pharmacotherapy, 2013, Volume: 27, Issue:2

    Topics: Administration, Buccal; Administration, Intranasal; Administration, Oral; Analgesics, Opioid; Breakt

2013
[Breakthrough pain and short-acting opioids].
    Der Anaesthesist, 2013, Volume: 62, Issue:6

    Topics: Administration, Intranasal; Administration, Mucosal; Analgesics, Opioid; Breakthrough Pain; Delayed-

2013
[Management of breakthrough cancer pain].
    Klinicka onkologie : casopis Ceske a Slovenske onkologicke spolecnosti, 2013, Volume: 26, Issue:3

    Topics: Administration, Buccal; Analgesics, Opioid; Breakthrough Pain; Fentanyl; Humans; Neoplasms; Pain Man

2013
Opioids for the management of breakthrough pain in cancer patients.
    The Cochrane database of systematic reviews, 2013, Oct-21, Issue:10

    Topics: Administration, Intranasal; Administration, Oral; Analgesics, Opioid; Breakthrough Pain; Fentanyl; H

2013
Various formulations of oral transmucosal fentanyl for breakthrough cancer pain: an indirect mixed treatment comparison meta-analysis.
    BMJ supportive & palliative care, 2012, Volume: 2, Issue:2

    Topics: Administration, Sublingual; Adult; Aged; Analgesics, Opioid; Breakthrough Pain; Chemistry, Pharmaceu

2012
Breakthrough cancer pain (BTcP): a synthesis of taxonomy, pathogenesis, therapy, and good clinical practice in adult patients in Italy.
    Advances in therapy, 2014, Volume: 31, Issue:7

    Topics: Analgesics, Opioid; Breakthrough Pain; Caregivers; Drug Administration Routes; Family; Fentanyl; Hum

2014
Clinical and pharmacokinetic considerations of novel formulations of fentanyl for breakthrough cancer pain.
    Pain management, 2014, Volume: 4, Issue:5

    Topics: Breakthrough Pain; Chemistry, Pharmaceutical; Fentanyl; Humans; Neoplasms

2014
Fentanyl buccal tablet for the treatment of cancer-related breakthrough pain.
    Expert review of clinical pharmacology, 2015, Volume: 8, Issue:1

    Topics: Administration, Buccal; Analgesics, Opioid; Breakthrough Pain; Clinical Trials as Topic; Dose-Respon

2015
WITHDRAWN: Opioids for the management of breakthrough pain in cancer patients.
    The Cochrane database of systematic reviews, 2015, Aug-14, Issue:8

    Topics: Administration, Intranasal; Administration, Oral; Analgesics, Opioid; Breakthrough Pain; Fentanyl; H

2015
Breakthrough pain and its treatment: critical review and recommendations of IOPS (Italian Oncologic Pain Survey) expert group.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2016, Volume: 24, Issue:2

    Topics: Algorithms; Analgesics, Opioid; Breakthrough Pain; Choice Behavior; Ethnicity; Expert Testimony; Fen

2016
Efficacy and Safety of Oral or Nasal Fentanyl for Treatment of Breakthrough Pain in Cancer Patients: A Systematic Review.
    Journal of pain & palliative care pharmacotherapy, 2015, Volume: 29, Issue:3

    Topics: Administration, Buccal; Administration, Intranasal; Administration, Sublingual; Analgesics, Opioid;

2015
Fentanyl Buccal Soluble Film: A Review in Breakthrough Cancer Pain.
    Clinical drug investigation, 2016, Volume: 36, Issue:5

    Topics: Administration, Buccal; Analgesics, Opioid; Breakthrough Pain; Disease Management; Fentanyl; Humans;

2016
Fentanyl citrate sublingual formulation (Vellofent®) for quick BTcP hindering.
    Minerva medica, 2016, Volume: 107, Issue:2

    Topics: Administration, Sublingual; Analgesics, Opioid; Breakthrough Pain; Fentanyl; Humans; Neoplasms; Pain

2016
[Cancer breakthrough pain. Indications for rapidly effective opioids].
    Der Anaesthesist, 2011, Volume: 60, Issue:7

    Topics: Administration, Intranasal; Administration, Sublingual; Administration, Topical; Aerosols; Analgesic

2011
Opioids for the management of breakthrough cancer pain in adults: a systematic review undertaken as part of an EPCRC opioid guidelines project.
    Palliative medicine, 2011, Volume: 25, Issue:5

    Topics: Administration, Oral; Analgesics, Opioid; Breakthrough Pain; Europe; Fentanyl; Humans; Neoplasms; Pa

2011
Fentanyl for breakthrough pain: a systematic review.
    Expert review of neurotherapeutics, 2011, Volume: 11, Issue:8

    Topics: Acute Pain; Administration, Buccal; Administration, Intranasal; Administration, Mucosal; Administrat

2011
Newer generation fentanyl transmucosal products for breakthrough pain in opioid-tolerant cancer patients.
    Clinical drug investigation, 2011, Volume: 31, Issue:9

    Topics: Administration, Oral; Analgesics, Opioid; Breakthrough Pain; Controlled Clinical Trials as Topic; Dr

2011
Pharmacokinetics of fentanyl buccal tablet: a pooled analysis and review.
    Pain practice : the official journal of World Institute of Pain, 2012, Volume: 12, Issue:4

    Topics: Administration, Buccal; Adolescent; Adult; Analgesics, Opioid; Breakthrough Pain; Female; Fentanyl;

2012
Intranasal fentanyl in the treatment of acute pain--a systematic review.
    Acta anaesthesiologica Scandinavica, 2012, Volume: 56, Issue:4

    Topics: Acute Pain; Administration, Intranasal; Analgesics, Opioid; Breakthrough Pain; Fentanyl; Humans; Pai

2012
New formulations of fentanyl for acute pain management.
    Drugs of today (Barcelona, Spain : 1998), 2012, Volume: 48, Issue:2

    Topics: Acute Pain; Administration, Cutaneous; Administration, Intranasal; Administration, Oral; Analgesics,

2012
Oral trasmucosal fentanyl citrate for breakthrough pain treatment in cancer patients.
    Expert opinion on pharmacotherapy, 2012, Volume: 13, Issue:6

    Topics: Administration, Oral; Analgesics, Opioid; Breakthrough Pain; Clinical Trials as Topic; Fentanyl; Hum

2012
A comprehensive review of rapid-onset opioids for breakthrough pain.
    CNS drugs, 2012, Jun-01, Volume: 26, Issue:6

    Topics: Breakthrough Pain; Chronic Pain; Drug Administration Routes; Fentanyl; Humans; Patient Satisfaction;

2012
Population pharmacokinetic meta-analysis of intranasal fentanyl spray as a means to enrich pharmacokinetic information for patients with cancer breakthrough pain.
    International journal of clinical pharmacology and therapeutics, 2012, Volume: 50, Issue:9

    Topics: Administration, Intranasal; Aerosols; Analgesics, Opioid; Area Under Curve; Breakthrough Pain; Compu

2012
Intranasal fentanyl spray: a novel dosage form for the treatment of breakthrough cancer pain.
    The Annals of pharmacotherapy, 2012, Volume: 46, Issue:10

    Topics: Administration, Intranasal; Analgesics, Opioid; Breakthrough Pain; Fentanyl; Humans; Neoplasms

2012
The management of wound-related procedural pain (volitional incident pain) in advanced illness.
    Current opinion in supportive and palliative care, 2013, Volume: 7, Issue:1

    Topics: Administration, Buccal; Administration, Intranasal; Analgesics, Opioid; Breakthrough Pain; Cognition

2013
Fentanyl for breakthrough cancer pain: where are we?
    Reviews on recent clinical trials, 2013, Volume: 8, Issue:1

    Topics: Administration, Mucosal; Administration, Sublingual; Analgesics, Opioid; Breakthrough Pain; Fentanyl

2013
Optimal management of breakthrough cancer pain (BCP).
    Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 2013, Volume: 15, Issue:7

    Topics: Administration, Intranasal; Analgesics, Opioid; Breakthrough Pain; Fentanyl; Humans; Nasal Sprays; N

2013
Efficacy of rapid-onset oral fentanyl formulations vs. oral morphine for cancer-related breakthrough pain: a meta-analysis of comparative trials.
    Journal of pain and symptom management, 2013, Volume: 46, Issue:4

    Topics: Administration, Oral; Analgesics, Opioid; Breakthrough Pain; Causality; Comorbidity; Controlled Clin

2013

Trials

39 trials available for fentanyl and Pain, Breakthrough

ArticleYear
Efficacy of reconstituted intravenous fentanyl to sublingual solution versus oral morphine syrup for breakthrough pain among patients with chronic gynecologic cancer pain: A randomized, double-blind, placebo-controlled trial.
    The journal of obstetrics and gynaecology research, 2023, Volume: 49, Issue:7

    Topics: Administration, Sublingual; Adolescent; Adult; Analgesics, Opioid; Breakthrough Pain; Cancer Pain; D

2023
Comparative efficacy of epidural clonidine versus epidural fentanyl for treating breakthrough pain during labor: a randomized double-blind clinical trial.
    International journal of obstetric anesthesia, 2020, Volume: 42

    Topics: Adult; Analgesia, Epidural; Analgesia, Obstetrical; Analgesics; Analgesics, Opioid; Breakthrough Pai

2020
A dose titration study of fentanyl buccal soluble film for breakthrough cancer pain in Taiwan.
    Cancer reports (Hoboken, N.J.), 2019, Volume: 2, Issue:5

    Topics: Administration, Buccal; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Breakthrough Pain; Cance

2019
Efficacy, safety, and tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain: a randomized, double-blind, placebo-controlled study.
    Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences, 2021, Volume: 29, Issue:1

    Topics: Administration, Sublingual; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Breakthrough Pain; C

2021
Intranasal Fentanyl for Intervention-Associated Breakthrough Pain After Cardiac Surgery.
    Clinical pharmacokinetics, 2021, Volume: 60, Issue:7

    Topics: Administration, Intranasal; Aged; Analgesics, Opioid; Breakthrough Pain; Cardiac Surgical Procedures

2021
Healthcare professionals' views of the use of oral morphine and transmucosal diamorphine in the management of paediatric breakthrough pain and the feasibility of a randomised controlled trial: A focus group study (DIPPER).
    Palliative medicine, 2021, Volume: 35, Issue:6

    Topics: Analgesics, Opioid; Breakthrough Pain; Child; Delivery of Health Care; Feasibility Studies; Fentanyl

2021
Facilitation of accurate and effective radiation therapy using fentanyl pectin nasal spray (FPNS) to reduce incidental breakthrough pain due to procedure positioning.
    Scandinavian journal of pain, 2016, Volume: 11

    Topics: Analgesics, Opioid; Bone Neoplasms; Breakthrough Pain; Fentanyl; Humans; Nasal Sprays; Pectins; Radi

2016
[Fentanyl buccal tablets in the treatment of breakthrough cancer pain. German cohort of a pan-European multicentre study].
    MMW Fortschritte der Medizin, 2018, Volume: 160, Issue:Suppl 4

    Topics: Administration, Buccal; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Breakthrough Pain; Cance

2018
Proportional dose of rapid-onset opioid in breakthrough cancer pain management: An open-label, multicenter study.
    Medicine, 2018, Volume: 97, Issue:30

    Topics: Administration, Buccal; Adult; Aged; Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Dose-Respon

2018
The efficacy of oral piroxicam fast-dissolving tablets versus sublingual fentanyl in incident breakthrough pain due to bone metastases: a double-blinded randomized study.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2019, Volume: 27, Issue:6

    Topics: Administration, Sublingual; Anti-Inflammatory Agents, Non-Steroidal; Bone Neoplasms; Breakthrough Pa

2019
Is breakthrough pain better managed by adding programmed intermittent epidural bolus to a background infusion during labor epidural analgesia? A randomized controlled trial.
    Minerva anestesiologica, 2019, Volume: 85, Issue:10

    Topics: Adolescent; Adult; Analgesia, Epidural; Analgesia, Obstetrical; Anesthetics, Intravenous; Anesthetic

2019
Programmed intermittent epidural bolus as compared to continuous epidural infusion for the maintenance of labor analgesia: a prospective randomized single-blinded controlled trial.
    Korean journal of anesthesiology, 2019, Volume: 72, Issue:5

    Topics: Adult; Analgesia, Epidural; Analgesia, Obstetrical; Anesthetics, Local; Breakthrough Pain; Drug Admi

2019
Breakthrough pain in patients with head & neck cancer. A secondary analysis of IOPS MS study.
    Oral oncology, 2019, Volume: 95

    Topics: Administration, Intranasal; Adolescent; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Breakthr

2019
An innovative phase I population pharmacokinetic approach to investigate the pharmacokinetics of an intranasal fentanyl spray in healthy subjects.
    International journal of clinical pharmacology and therapeutics, 2013, Volume: 51, Issue:6

    Topics: Administration, Intranasal; Adolescent; Adult; Analgesics, Opioid; Breakthrough Pain; Computer Simul

2013
Fentanyl buccal tablet compared with immediate-release oxycodone for the management of breakthrough pain in opioid-tolerant patients with chronic cancer and noncancer pain: a randomized, double-blind, crossover study followed by a 12-week open-label phase
    Pain medicine (Malden, Mass.), 2013, Volume: 14, Issue:9

    Topics: Administration, Buccal; Adolescent; Adult; Aged; Aged, 80 and over; Analgesics; Breakthrough Pain; C

2013
Efficacy and safety of sublingual fentanyl orally disintegrating tablets in patients with breakthrough pain: multicentre prospective study.
    Clinical drug investigation, 2013, Volume: 33, Issue:9

    Topics: Administration, Sublingual; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Breakthrough Pain; F

2013
A randomized, double-blind, placebo-controlled study of fentanyl buccal tablets for breakthrough pain: efficacy and safety in Japanese cancer patients.
    Journal of pain and symptom management, 2014, Volume: 47, Issue:6

    Topics: Administration, Buccal; Aged; Analgesics, Opioid; Breakthrough Pain; Double-Blind Method; Female; Fe

2014
A report on the long-term use of fentanyl pectin nasal spray in patients with recurrent breakthrough pain.
    Journal of pain and symptom management, 2014, Volume: 47, Issue:6

    Topics: Administration, Intranasal; Adult; Aged; Analgesics, Opioid; Breakthrough Pain; Drug Combinations; F

2014
Fentanyl buccal film. New oral transmucosal form has no advantages in breakthrough pain.
    Prescrire international, 2013, Volume: 22, Issue:142

    Topics: Administration, Oral; Analgesics, Opioid; Breakthrough Pain; Cheek; Fentanyl; Humans; Mouth Mucosa

2013
Efficacy of sublingual fentanyl vs. oral morphine for cancer-related breakthrough pain.
    Advances in therapy, 2014, Volume: 31, Issue:1

    Topics: Administration, Oral; Administration, Sublingual; Aged; Analgesics, Opioid; Breakthrough Pain; Doubl

2014
A randomized, placebo-controlled study of a new sublingual formulation of fentanyl citrate (fentanyl ethypharm) for breakthrough pain in opioid-treated patients with cancer.
    Clinical therapeutics, 2014, Mar-01, Volume: 36, Issue:3

    Topics: Administration, Sublingual; Adult; Aged; Analgesics, Opioid; Breakthrough Pain; Cross-Over Studies;

2014
Intranasal fentanyl versus fentanyl pectin nasal spray for the management of breakthrough cancer pain in doses proportional to basal opioid regimen.
    The journal of pain, 2014, Volume: 15, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Breakthrough Pain; Cross-Sectional Studies; Dose

2014
Aberrant drug-related behavior observed during a 12-week open-label extension period of a study involving patients taking chronic opioid therapy for persistent pain and fentanyl buccal tablet or traditional short-acting opioid for breakthrough pain.
    Pain medicine (Malden, Mass.), 2014, Volume: 15, Issue:8

    Topics: Administration, Buccal; Analgesics, Opioid; Breakthrough Pain; Chronic Pain; Cross-Over Studies; Dos

2014
Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined by titration for the treatment of breakthrough pain in Japanese cancer patients: a multicenter, randomized, placebo-controlled, double-blind phase III trial.
    International journal of clinical oncology, 2015, Volume: 20, Issue:1

    Topics: Administration, Sublingual; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Breakthrough Pain; D

2015
Patient Satisfaction with Fentanyl Sublingual Spray in Opioid-Tolerant Patients with Breakthrough Cancer Pain.
    Pain practice : the official journal of World Institute of Pain, 2015, Volume: 15, Issue:6

    Topics: Administration, Sublingual; Adult; Aged; Analgesics, Opioid; Breakthrough Pain; Female; Fentanyl; Hu

2015
Pan-European, open-label dose titration study of fentanyl buccal tablet in patients with breakthrough cancer pain.
    European journal of pain (London, England), 2015, Volume: 19, Issue:4

    Topics: Adult; Aged; Analgesics, Opioid; Breakthrough Pain; Dose-Response Relationship, Drug; Ethnicity; Fem

2015
Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined from oral morphine rescue doses in the treatment of breakthrough cancer pain.
    Japanese journal of clinical oncology, 2015, Volume: 45, Issue:2

    Topics: Administration, Oral; Administration, Sublingual; Adult; Aged; Analgesics, Opioid; Breakthrough Pain

2015
Breakthrough pain management using fentanyl buccal tablet (FBT) in combination with around-the-clock (ATC) opioids based on the efficacy and safety of FBT, and its relationship with ATC opioids: results from an open-label, multi-center study in Japanese c
    Japanese journal of clinical oncology, 2015, Volume: 45, Issue:1

    Topics: Administration, Buccal; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Asian People; Breakthrou

2015
Improved patient functioning after treatment of breakthrough cancer pain: an open-label study of fentanyl buccal tablet in patients with cancer pain.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2015, Volume: 23, Issue:7

    Topics: Administration, Buccal; Adult; Affect; Analgesics, Opioid; Breakthrough Pain; Female; Fentanyl; Huma

2015
Efficacy and tolerability of intranasal fentanyl spray in cancer patients with breakthrough pain.
    Clinical therapeutics, 2015, Mar-01, Volume: 37, Issue:3

    Topics: Adult; Aged; Analgesics, Opioid; Breakthrough Pain; Cross-Over Studies; Double-Blind Method; Female;

2015
Efficacy and safety of sublingual fentanyl tablets for the management of breakthrough pain in patients with chronic musculoskeletal pain with neuropathic component: multicenter prospective study.
    Clinical drug investigation, 2015, Volume: 35, Issue:3

    Topics: Administration, Sublingual; Adult; Aged; Aged, 80 and over; Breakthrough Pain; Drug-Related Side Eff

2015
Fentanyl Buccal Tablet vs. Oral Morphine in Doses Proportional to the Basal Opioid Regimen for the Management of Breakthrough Cancer Pain: A Randomized, Crossover, Comparison Study.
    Journal of pain and symptom management, 2015, Volume: 50, Issue:5

    Topics: Administration, Buccal; Analgesics, Opioid; Breakthrough Pain; Cross-Over Studies; Female; Fentanyl;

2015
Long-term safety of fentanyl sublingual spray in opioid-tolerant patients with breakthrough cancer pain.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2016, Volume: 24, Issue:6

    Topics: Administration, Sublingual; Adult; Aged; Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Double-

2016
A COMPARATIVE STUDY ON THE EFFICACY OF TWO REGIMENS OF SINGLE- SHOT SPINAL BLOCK FOR PAIN RELIEF IN WOMEN PRESENTING IN ESTABLISHED LABOUR.
    East African medical journal, 2013, Volume: 90, Issue:1

    Topics: Analgesia, Obstetrical; Analgesics, Opioid; Anesthesia, Spinal; Anesthetics, Combined; Anesthetics,

2013
Fentanyl sublingual spray for breakthrough cancer pain in patients receiving transdermal fentanyl.
    Pain management, 2016, Volume: 6, Issue:5

    Topics: Administration, Cutaneous; Administration, Sublingual; Adult; Aged; Aged, 80 and over; Analgesics, O

2016
Fentanyl Pectin Nasal Spray Versus Oral Morphine in Doses Proportional to the Basal Opioid Regimen for the Management of Breakthrough Cancer Pain: A Comparative Study.
    Journal of pain and symptom management, 2016, Volume: 52, Issue:1

    Topics: Administration, Oral; Analgesics; Breakthrough Pain; Cancer Pain; Cross-Over Studies; Female; Fentan

2016
Efficacy of oxycodone/paracetamol for patients with bone-cancer pain: a multicenter, randomized, double-blinded, placebo-controlled trial.
    Journal of clinical pharmacy and therapeutics, 2012, Volume: 37, Issue:1

    Topics: Acetaminophen; Administration, Oral; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Bone Neopla

2012
Successful dose finding with sublingual fentanyl tablet: combined results from 2 open-label titration studies.
    Pain practice : the official journal of World Institute of Pain, 2012, Volume: 12, Issue:6

    Topics: Administration, Sublingual; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Breakthrough Pain; D

2012
Dosing fentanyl buccal tablet for breakthrough cancer pain: dose titration versus proportional doses.
    Current medical research and opinion, 2012, Volume: 28, Issue:6

    Topics: Administration, Oral; Aged; Analgesics, Opioid; Breakthrough Pain; Dose-Response Relationship, Drug;

2012

Other Studies

80 other studies available for fentanyl and Pain, Breakthrough

ArticleYear
Low-dose sublingual fentanyl improves quality of life in patients with breakthrough cancer pain in palliative care.
    Future oncology (London, England), 2022, Volume: 18, Issue:14

    Topics: Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Fentanyl; Humans; Neoplasms; Palliative Care; Pr

2022
Predicting tolerability of high-dose fentanyl buccal tablets in cancer patients.
    PloS one, 2023, Volume: 18, Issue:1

    Topics: Administration, Buccal; Analgesics, Opioid; Breakthrough Pain; Fentanyl; Humans; Male; Neoplasms; Pa

2023
Breakthrough pain in patients with multiple myeloma: a secondary analysis of IOPS MS study.
    European review for medical and pharmacological sciences, 2023, Volume: 27, Issue:3

    Topics: Analgesics, Opioid; Breakthrough Pain; Fentanyl; Humans; Multiple Myeloma; Neoplasms; Pain Managemen

2023
Association between breakthrough labor pain, patient-controlled epidural analgesia use, and numeracy: A pilot observational study.
    Midwifery, 2023, Volume: 124

    Topics: Analgesia, Epidural; Analgesia, Obstetrical; Anesthetics, Local; Breakthrough Pain; Female; Fentanyl

2023
Effectiveness of Risk Minimization Measures for Fentanyl Buccal Tablet (FENTORA) in Canada: A Mixed-Methods Evaluation Using Surveys, Medical Chart Records and Web Surveillance.
    Drug safety, 2020, Volume: 43, Issue:2

    Topics: Administration, Buccal; Adolescent; Adult; Aged; Analgesics, Opioid; Breakthrough Pain; Canada; Canc

2020
Buccal opioids for breakthrough pain in children with life-limiting conditions receiving end-of-life care.
    International journal of palliative nursing, 2019, Oct-02, Volume: 25, Issue:10

    Topics: Administration, Buccal; Adolescent; Analgesics, Opioid; Breakthrough Pain; Child; Child, Preschool;

2019
A Case of Breakthrough Pain Management with Subcutaneous Fentanyl Administration in a Female Child.
    Journal of the College of Physicians and Surgeons--Pakistan : JCPSP, 2020, Volume: 30, Issue:6

    Topics: Administration, Oral; Analgesics, Opioid; Breakthrough Pain; Child; Diagnostic Tests, Routine; Femal

2020
[Comparison of hospital consumption of immediate-release fentanyl: use or abuse?]
    Revista espanola de salud publica, 2020, Jul-28, Volume: 94

    Topics: Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Breakthrough Pain; Cross-Sectional Studies; Drug

2020
Pseudo-addiction in cancer patients and rapid-release fentanyl for breakthrough pain: An increasingly common concern.
    Medicina clinica, 2021, 09-24, Volume: 157, Issue:6

    Topics: Analgesics, Opioid; Breakthrough Pain; Fentanyl; Humans; Neoplasms

2021
[A Case Report of Impaired Consciousness in a Patient after Receiving the Fourth Dose of Fentanyl Sublingual Tablet].
    Gan to kagaku ryoho. Cancer & chemotherapy, 2020, Volume: 47, Issue:10

    Topics: Administration, Sublingual; Aged; Analgesics, Opioid; Breakthrough Pain; Consciousness; Fentanyl; Hu

2020
The role of fentanyl in the treatment of breakthrough cancer pain: Different biotechnologies, different results and different drug costs.
    Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners, 2021, Volume: 27, Issue:2

    Topics: Administration, Buccal; Administration, Intranasal; Administration, Oral; Analgesics, Opioid; Breakt

2021
[A New Therapeutic Approach for Cancer-Related Breakthrough Pain - Focused on Oral Transmucosal Fentanyl].
    Gan to kagaku ryoho. Cancer & chemotherapy, 2017, Volume: 44, Issue:4

    Topics: Administration, Oral; Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Fentanyl; Humans; Mouth Mu

2017
Cost-effectiveness analysis of oral fentanyl formulations for breakthrough cancer pain treatment.
    PloS one, 2017, Volume: 12, Issue:6

    Topics: Administration, Oral; Administration, Sublingual; Analgesics, Opioid; Breakthrough Pain; Cancer Pain

2017
Breakthrough Pain Management with Sublingual Fentanyl Tablets in Patients with Cancer: Age Subgroup Analysis of a Multicenter Prospective Study.
    Drugs in R&D, 2017, Volume: 17, Issue:3

    Topics: Administration, Sublingual; Age Factors; Aged; Analgesics, Opioid; Anxiety; Breakthrough Pain; Cance

2017
Barriers to the use of buccal and intranasal fentanyl for breakthrough pain in paediatric palliative care: an exploratory survey.
    BMJ supportive & palliative care, 2018, Volume: 8, Issue:3

    Topics: Administration, Buccal; Administration, Intranasal; Adolescent; Analgesics, Opioid; Breakthrough Pai

2018
Fentanyl buccal tablet for breakthrough cancer pain in clinical practice: results of the non-interventional prospective study ErkentNIS.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2018, Volume: 26, Issue:2

    Topics: Administration, Buccal; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Breakthrough Pain; Cance

2018
Transmucosal fentanyl for severe cancer pain: Nasal mucosa superior to oral mucosa?
    Scandinavian journal of pain, 2016, Volume: 11

    Topics: Breakthrough Pain; Cancer Pain; Fentanyl; Humans; Mouth Mucosa; Nasal Mucosa

2016
Characteristics and Treatment of Breakthrought Pain (BTcP) in Palliative Care.
    Medical archives (Sarajevo, Bosnia and Herzegovina), 2017, Volume: 71, Issue:4

    Topics: Acetaminophen; Adult; Aged; Aged, 80 and over; Analgesia, Patient-Controlled; Analgesics, Non-Narcot

2017
The use of rapid onset fentanyl in children and young people for breakthrough cancer pain.
    Scandinavian journal of pain, 2017, Volume: 17

    Topics: Administration, Oral; Adolescent; Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Child; Child,

2017
[Transmucosal fentanyl administration: sublingual, buccal, nasal - all the same? Treatment of breakthrough cancer pain].
    MMW Fortschritte der Medizin, 2017, Volume: 159, Issue:Suppl 6

    Topics: Administration, Mucosal; Administration, Sublingual; Analgesics, Opioid; Breakthrough Pain; Cancer P

2017
Efficacy and Safety of Sublingual Fentanyl Tablets in Breakthrough Cancer Pain Management According to Cancer Stage and Background Opioid Medication.
    Drugs in R&D, 2018, Volume: 18, Issue:2

    Topics: Administration, Sublingual; Aged; Analgesics, Opioid; Breakthrough Pain; Drug Combinations; Drug The

2018
Breakthrough cancer pain tailored treatment: which factors influence the medication choice? An observational, prospective and cross-sectional study in patients with terminal cancer.
    Postgraduate medical journal, 2018, Volume: 94, Issue:1116

    Topics: Administration, Buccal; Administration, Intranasal; Aged; Aged, 80 and over; Analgesics, Opioid; Bre

2018
Factors influencing the use of opioids for breakthrough cancer pain: A secondary analysis of the IOPS-MS study.
    European journal of pain (London, England), 2019, Volume: 23, Issue:4

    Topics: Adolescent; Adult; Age Factors; Aged; Aged, 80 and over; Analgesics, Opioid; Breakthrough Pain; Canc

2019
[Not all pains are the same: breakthrough pain in cancer patients. A case report].
    Recenti progressi in medicina, 2018, Volume: 109, Issue:11

    Topics: Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Fentanyl; Humans; Male; Middle Aged; Palliative

2018
Assessment of the FDA Risk Evaluation and Mitigation Strategy for Transmucosal Immediate-Release Fentanyl Products.
    JAMA, 2019, Feb-19, Volume: 321, Issue:7

    Topics: Administration, Mucosal; Breakthrough Pain; Cancer Pain; Clinical Competence; Contraindications, Dru

2019
[Breaktrough cancer pain in metastatic prostate adenocarcinoma: a case report.]
    Recenti progressi in medicina, 2019, Volume: 110, Issue:3

    Topics: Adenocarcinoma; Administration, Sublingual; Analgesics, Opioid; Bone Neoplasms; Breakthrough Pain; C

2019
Expert consensus on the management of breakthrough cancer pain in older patients. A Delphi study.
    Journal of geriatric oncology, 2019, Volume: 10, Issue:4

    Topics: Administration, Mucosal; Aged; Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Central Nervous S

2019
Effectiveness of fentanyl pectin nasal citrate in controlling episodes of breakthrough cancer pain triggered by routine radiotherapy procedures.
    Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 2019, Volume: 21, Issue:11

    Topics: Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Female; Fentanyl

2019
Effects of Age Among Elderly Cancer Patients on Breakthrough Pain Management with Sublingual Fentanyl Tablets.
    Drugs in R&D, 2019, Volume: 19, Issue:3

    Topics: Administration, Sublingual; Aged; Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Female; Fentan

2019
Grading clinical guidelines for the use of transmucosal immediate-release fentanyl products in breakthrough pain.
    International journal of palliative nursing, 2013, Volume: 19, Issue:2

    Topics: Analgesics, Opioid; Breakthrough Pain; Fentanyl; Humans; Mucous Membrane; Practice Guidelines as Top

2013
Comment: intranasal fentanyl spray: a novel dosage form for the treatment of breakthrough cancer pain.
    The Annals of pharmacotherapy, 2013, Volume: 47, Issue:3

    Topics: Analgesics, Opioid; Breakthrough Pain; Fentanyl; Humans; Neoplasms

2013
Comment: intranasal fentanyl spray: a novel dosage form for the treatment of breakthrough cancer pain.
    The Annals of pharmacotherapy, 2013, Volume: 47, Issue:3

    Topics: Analgesics, Opioid; Breakthrough Pain; Fentanyl; Humans; Neoplasms

2013
Comment: intranasal fentanyl spray: a novel dosage form for the treatment of breakthrough cancer pain. Authors' reply.
    The Annals of pharmacotherapy, 2013, Volume: 47, Issue:3

    Topics: Analgesics, Opioid; Breakthrough Pain; Fentanyl; Humans; Neoplasms

2013
Evidence-based treatment of cancer-related breakthrough pain with opioids.
    Journal of the National Comprehensive Cancer Network : JNCCN, 2013, Volume: 11 Suppl 1

    Topics: Administration, Mucosal; Administration, Sublingual; Analgesics, Opioid; Breakthrough Pain; Evidence

2013
The use of fentanyl buccal tablets for breakthrough pain by using doses proportional to opioid basal regimen in a home care setting.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2013, Volume: 21, Issue:8

    Topics: Administration, Buccal; Aged; Aged, 80 and over; Analgesics, Opioid; Breakthrough Pain; Dose-Respons

2013
[Cancer patient with breakthrough pain].
    MMW Fortschritte der Medizin, 2013, Feb-21, Volume: 155, Issue:3

    Topics: Aged; Analgesics, Opioid; Breakthrough Pain; Breast Neoplasms; Disease Progression; Dose-Response Re

2013
[Fentanyl: fast and furious?].
    Der Anaesthesist, 2013, Volume: 62, Issue:6

    Topics: Analgesics, Opioid; Breakthrough Pain; Fentanyl; Humans; Neoplasms; Pain; Pain, Intractable

2013
The use of sublingual fentanyl for breakthrough pain by using doses proportional to opioid basal regimen.
    Current medical research and opinion, 2013, Volume: 29, Issue:11

    Topics: Administration, Sublingual; Aged; Analgesics, Opioid; Breakthrough Pain; Female; Fentanyl; Humans; M

2013
Treatment of breakthrough cancer pain: to titrate or to proportionate?
    Current medical research and opinion, 2013, Volume: 29, Issue:11

    Topics: Breakthrough Pain; Female; Fentanyl; Humans; Male

2013
Correspondence (letter to the editor): Lack of precision in colloquial language results in incorrect therapeutic recommendation.
    Deutsches Arzteblatt international, 2013, Volume: 110, Issue:35-36

    Topics: Breakthrough Pain; Evidence-Based Medicine; Fentanyl; Humans; Neoplasms; Pain Measurement

2013
Correspondence (reply): In reply.
    Deutsches Arzteblatt international, 2013, Volume: 110, Issue:35-36

    Topics: Breakthrough Pain; Evidence-Based Medicine; Fentanyl; Humans; Neoplasms; Pain Measurement

2013
Safety profile of intravenous patient-controlled analgesia for breakthrough pain in cancer patients: a case series study.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2014, Volume: 22, Issue:3

    Topics: Adult; Analgesia, Patient-Controlled; Analgesics; Breakthrough Pain; Constipation; Female; Fentanyl;

2014
The use of Instanyl® in the treatment of breakthrough pain in cancer patients: a 3-month observational, prospective, cohort study.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2014, Volume: 22, Issue:6

    Topics: Administration, Intranasal; Aged; Analgesics, Opioid; Breakthrough Pain; Female; Fentanyl; Humans; M

2014
How practical are transmucosal fentanyl products for breakthrough cancer pain? Novel use of placebo formulations to survey user opinion.
    BMJ supportive & palliative care, 2011, Volume: 1, Issue:3

    Topics: Administration, Buccal; Administration, Intranasal; Administration, Mucosal; Administration, Subling

2011
Cost-effectiveness analysis of transnasal fentanyl citrate for the treatment of breakthrough cancer pain.
    Expert review of pharmacoeconomics & outcomes research, 2014, Volume: 14, Issue:3

    Topics: Administration, Intranasal; Analgesics, Opioid; Breakthrough Pain; Cost-Benefit Analysis; Fentanyl;

2014
Efficacy of rapid-onset oral fentanyl: what does it mean?
    Journal of pain and symptom management, 2014, Volume: 48, Issue:1

    Topics: Breakthrough Pain; Evidence-Based Medicine; Female; Fentanyl; Humans; Male; Morphine; Neoplasms

2014
Trial design for breakthrough pain: is it ethical to have a placebo in a trial? Author reply.
    Clinical therapeutics, 2014, Volume: 36, Issue:5

    Topics: Analgesics, Opioid; Breakthrough Pain; Female; Fentanyl; Humans; Male

2014
Trial design for breakthrough pain: is it ethical to have a placebo in a trial?
    Clinical therapeutics, 2014, Volume: 36, Issue:5

    Topics: Analgesics, Opioid; Breakthrough Pain; Female; Fentanyl; Humans; Male

2014
Authors' reply to Davis.
    Journal of pain and symptom management, 2014, Volume: 48, Issue:1

    Topics: Breakthrough Pain; Evidence-Based Medicine; Female; Fentanyl; Humans; Male; Morphine; Neoplasms

2014
Rapid-onset opioids for the treatment of breakthrough cancer pain: two cases of drug abuse.
    Pain medicine (Malden, Mass.), 2014, Volume: 15, Issue:5

    Topics: Analgesics, Opioid; Breakthrough Pain; Chemoradiotherapy; Coma; Fentanyl; Gastrointestinal Stromal T

2014
Fentanyl pectin nasal spray as treatment for incident predictable breakthrough pain (BTP) in oral mucositis induced by chemoradiotherapy in head and neck cancer.
    Oral oncology, 2014, Volume: 50, Issue:9

    Topics: Administration, Inhalation; Adult; Aged; Analgesics, Opioid; Breakthrough Pain; Combined Modality Th

2014
A randomized, placebo-controlled study of a new sublingual formulation of fentanyl citrate (fentanyl ethypharm) for breakthrough pain in opioid-treated patients with cancer.
    Clinical therapeutics, 2014, Nov-01, Volume: 36, Issue:11

    Topics: Analgesics, Opioid; Breakthrough Pain; Female; Fentanyl; Humans; Male

2014
Breakthrough cancer pain: a comparison of surveys with European and Canadian patients.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2015, Volume: 23, Issue:3

    Topics: Administration, Oral; Adult; Aged; Analgesics, Opioid; Breakthrough Pain; Canada; Data Collection; E

2015
Long-term efficacy and tolerability of intranasal fentanyl in the treatment of breakthrough cancer pain.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2015, Volume: 23, Issue:5

    Topics: Administration, Intranasal; Adult; Aged; Analgesics, Opioid; Breakthrough Pain; Cohort Studies; Fema

2015
Patients' acceptability of different fentanyl products for breakthrough cancer pain.
    Clinical oncology (Royal College of Radiologists (Great Britain)), 2014, Volume: 26, Issue:12

    Topics: Administration, Mucosal; Breakthrough Pain; Fentanyl; Humans; Neoplasms; Patient Acceptance of Healt

2014
Pharmacologic management of adult breakthrough cancer pain.
    Canadian family physician Medecin de famille canadien, 2014, Volume: 60, Issue:12

    Topics: Adult; Analgesics, Opioid; Breakthrough Pain; Fentanyl; Humans; Neoplasms; Sufentanil

2014
Use of nasal fentanyl for cancer pain: A pharmacoepidemiological study.
    Palliative medicine, 2015, Volume: 29, Issue:7

    Topics: Administration, Intranasal; Adult; Aged; Analgesics, Opioid; Breakthrough Pain; Chronic Pain; Cohort

2015
Fentanyl pectin nasal spray for breakthrough cancer pain.
    International journal of palliative nursing, 2015, Volume: 21, Issue:3

    Topics: Administration, Intranasal; Analgesics, Opioid; Breakthrough Pain; Fentanyl; Humans; Neoplasms; Pect

2015
Use of oral formulations of fentanyl for breakthrough cancer pain.
    International journal of palliative nursing, 2015, Volume: 21, Issue:4

    Topics: Administration, Oral; Analgesics, Opioid; Breakthrough Pain; Cost-Benefit Analysis; Fentanyl; Humans

2015
Fentanyl Buccal Tablet: A New Breakthrough Pain Medication in Early Management of Severe Vaso-Occlusive Crisis in Sickle Cell Disease.
    Pain practice : the official journal of World Institute of Pain, 2016, Volume: 16, Issue:6

    Topics: Administration, Buccal; Adolescent; Adult; Analgesics, Opioid; Anemia, Sickle Cell; Anti-Inflammator

2016
A new once-a-day fentanyl citrate patch (Fentos Tape) could be a new treatment option in patients with end-of-dose failure using a 72-h transdermal fentanyl matrix patch.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2016, Volume: 24, Issue:3

    Topics: Administration, Cutaneous; Aged; Analgesics, Opioid; Breakthrough Pain; Cross-Sectional Studies; Fem

2016
Transmucosal Immediate-Release Fentanyl for Breakthrough Cancer Pain: Opportunities and Challenges for Use in Palliative Care.
    Journal of pain & palliative care pharmacotherapy, 2015, Volume: 29, Issue:3

    Topics: Administration, Buccal; Administration, Intranasal; Administration, Sublingual; Analgesics, Opioid;

2015
Sublingual Fentanyl Tablets for Relief of Breakthrough Pain in Cancer Patients and Association with Quality-of-Life Outcomes.
    Clinical drug investigation, 2015, Volume: 35, Issue:12

    Topics: Administration, Sublingual; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Breakthrough Pain; F

2015
The Influence of Low Salivary Flow Rates on the Absorption of a Sublingual Fentanyl Citrate Formulation for Breakthrough Cancer Pain.
    Journal of pain and symptom management, 2016, Volume: 51, Issue:3

    Topics: Administration, Sublingual; Aged; Analgesics, Opioid; Autonomic Agents; Breakthrough Pain; Cancer Pa

2016
Re: The Influence of Low Salivary Flow Rates on Sublingual Fentanyl Absorption for Breakthrough Cancer Pain.
    Journal of pain and symptom management, 2016, Volume: 51, Issue:5

    Topics: Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Fentanyl; Humans; Neoplasms

2016
Reply-Letter to the Editor: What to Do, and What Not to Do, When Diagnosing and Treating Breakthrough Cancer Pain (BTcP): Expert Opinion.
    Drugs, 2016, Volume: 76, Issue:10

    Topics: Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Expert Testimony; Fentanyl; Humans; Neoplasms

2016
Breakthrough pain: just pain?
    Pain, 2016, Volume: 157, Issue:12

    Topics: Analgesics, Opioid; Breakthrough Pain; Fentanyl; Humans; Neoplasms; Pain; Pain Measurement

2016
The use of low doses of a sublingual fentanyl formulation for breakthrough pain in patients receiving low doses of opioids.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2017, Volume: 25, Issue:2

    Topics: Administration, Sublingual; Aged; Analgesics, Opioid; Breakthrough Pain; Female; Fentanyl; Humans; M

2017
Fentanyl pectin nasal spray for painful mucositis in head and neck cancers during intensity-modulated radiation therapy with or without chemotherapy.
    Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 2017, Volume: 19, Issue:5

    Topics: Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Antineoplastic Agents; Breakthrough Pain; Cispla

2017
Opioid manufacturer bribed doctors to prescribe fentanyl inappropriately, US says.
    BMJ (Clinical research ed.), 2016, Dec-15, Volume: 355

    Topics: Analgesics, Opioid; Breakthrough Pain; Cancer Pain; Crime; Drug Industry; Fentanyl; Humans; Malpract

2016
Initial titration with 200 μg fentanyl buccal tablets: a retrospective safety analysis in Korean cancer patients.
    The Korean journal of internal medicine, 2018, Volume: 33, Issue:3

    Topics: Administration, Buccal; Adult; Aged; Aged, 80 and over; Analgesics, Opioid; Breakthrough Pain; Femal

2018
Aberrant drug-related behavior observed during clinical studies involving patients taking chronic opioid therapy for persistent pain and fentanyl buccal tablet for breakthrough pain.
    Journal of pain and symptom management, 2011, Volume: 41, Issue:1

    Topics: Administration, Oral; Adolescent; Adult; Aged; Analgesics, Opioid; Breakthrough Pain; Causality; Chr

2011
Long-term tolerability, efficacy and acceptability of fentanyl pectin nasal spray for breakthrough cancer pain.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2012, Volume: 20, Issue:3

    Topics: Absorption; Administration, Intranasal; Administration, Oral; Analgesics, Opioid; Breakthrough Pain;

2012
Fentanyl buccal tablets for breakthrough pain in highly tolerant cancer patients: preliminary data on the proportionality between breakthrough pain dose and background dose.
    Journal of pain and symptom management, 2011, Volume: 42, Issue:3

    Topics: Administration, Buccal; Adult; Aged; Analgesics, Opioid; Breakthrough Pain; Dose-Response Relationsh

2011
Emerging opioid abuse in terminal cancer patients taking oral transmucosal fentanyl citrate for breakthrough pain.
    Journal of pain and symptom management, 2011, Volume: 42, Issue:6

    Topics: Adult; Analgesics, Opioid; Bone Neoplasms; Breakthrough Pain; Fatal Outcome; Female; Fentanyl; Human

2011
Fentanyl pectin nasal spray for breakthrough cancer pain.
    Future oncology (London, England), 2012, Volume: 8, Issue:2

    Topics: Analgesics, Opioid; Breakthrough Pain; Female; Fentanyl; Humans; Male; Nasal Sprays; Neoplasms; Trea

2012
Patient satisfaction with intranasal fentanyl for breakthrough pain.
    Journal of palliative medicine, 2012, Volume: 15, Issue:6

    Topics: Administration, Intranasal; Adolescent; Adult; Aged; Analgesics, Opioid; Breakthrough Pain; Female;

2012
[Breakthrough pain in a patient with bronchial carcinoma. Oral morphine hardly possible - what can help?].
    MMW Fortschritte der Medizin, 2012, Jun-11, Volume: 154, Issue:11

    Topics: Administration, Cutaneous; Administration, Oral; Analgesics, Opioid; Breakthrough Pain; Carcinoma, B

2012
Are there cost benefits to fentanyl for breakthrough pain?
    Journal of pain and symptom management, 2012, Volume: 44, Issue:3

    Topics: Administration, Intranasal; Analgesics, Opioid; Breakthrough Pain; Cost-Benefit Analysis; Fentanyl;

2012
[Rapid release fentanyl administration forms. Comments of the Working Group on Tumor Pain of the German Pain Society].
    Schmerz (Berlin, Germany), 2013, Volume: 27, Issue:1

    Topics: Advertising; Analgesics, Opioid; Breakthrough Pain; Drug Industry; Drug Tolerance; Education; Fentan

2013