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.
Adolescent
Adult
Female
Humans
Analgesics, Opioid
/ administration & dosage
Breakthrough Pain
/ etiology
Cancer Pain
/ complications
Double-Blind Method
Fentanyl
/ administration & dosage
Genital Neoplasms, Female
/ complications
Morphine
/ administration & dosage
Treatment Outcome
Administration, Sublingual
breakthrough pain
cancer pain
fentanyl
morphine
sublingual administration
Journal
The journal of obstetrics and gynaecology research
ISSN: 1447-0756
Titre abrégé: J Obstet Gynaecol Res
Pays: Australia
ID NLM: 9612761
Informations de publication
Date de publication:
Jul 2023
Jul 2023
Historique:
received:
01
02
2023
accepted:
30
04
2023
medline:
5
7
2023
pubmed:
12
5
2023
entrez:
12
5
2023
Statut:
ppublish
Résumé
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. To evaluate the efficacy of reconstituted intravenous fentanyl to sublingual solution (IFS) in relieving breakthrough pain as compared with OM. In this randomized, double-blind, double-dummy, placebo-controlled trial, patients with gynecologic cancer aged ≥18 years experiencing chronic cancer pain with breakthrough pain were enrolled. Patients were randomly allocated (1:1) to receive either 50 μg IFS or 5 mg OM. Pain intensity level was assessed at 5, 15, 30, 45, 60, and 120 min after treatment. The primary outcome was the reduction in pain intensity at 15 min in the intention-to-treat population (ClinicalTrials.gov, NCT05037539). Between June 15, 2021 and December 30, 2021, 40 participants were equally and randomly assigned to receive IFS or OM. The primary outcome was significantly higher in the IFS group (4.25 vs. 1.05, p < 0.0001). The secondary outcomes also showed higher reduction in pain intensity at 5 min in the IFS group. Subsequent breakthrough pain did not differ between the two groups. However, the reduction in pain was lower in the IFS group at 45, 60, and 120 min, where pain was classified as mild. No severe adverse effects were observed in both groups. Burning sensation without noticeable lesion was found in 20% of the IFS group. IFS can reduce early breakthrough pain. IFS may be considered for breakthrough pain when rapid-acting fentanyl formulations are unavailable.
Substances chimiques
Analgesics, Opioid
0
Fentanyl
UF599785JZ
Morphine
76I7G6D29C
Banques de données
ClinicalTrials.gov
['NCT05037539']
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1815-1820Subventions
Organisme : The Rajavithi Research Management Fund
ID : N/A
Informations de copyright
© 2023 Japan Society of Obstetrics and Gynecology.
Références
Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain. 1990;41(3):273-81.
Gomez-Batiste X, Martinez-Munoz M, Blay C, Amblas J, Vila L, Costa X, et al. Prevalence and characteristics of patients with advanced chronic conditions in need of palliative care in the general population: a cross-sectional study. Palliat Med. 2014;28(4):302-11.
Mercadante S. Treating breakthrough pain in oncology. Expert Rev Anticancer Ther. 2018;18(5):445-9.
Davies AN, Elsner F, Filbet MJ, Porta-Sales J, Ripamonti C, Santini D, et al. Breakthrough cancer pain (BTcP) management: a review of international and national guidelines. BMJ Support Palliat Care. 2018;8(3):241-9.
Davies AN, Dickman A, Reid C, Stevens AM, Zeppetella G, Science Committee of the Association for Palliative Medicine of Great B Zeppetella G, Science Committee of the Association for Palliative Medicine of Great Britain and Ireland. The management of cancer-related breakthrough pain: recommendations of a task group of the Science Committee of the Association for Palliative Medicine of Great Britain and Ireland. Eur J Pain. 2009;13(4):331-8.
Mercadante S. The use of rapid onset opioids for breakthrough cancer pain: the challenge of its dosing. Crit Rev Oncol Hematol. 2011;80(3):460-5.
Portenoy RK, Payne D, Jacobsen P. Breakthrough pain: characteristics and impact in patients with cancer pain. Pain. 1999;81(1-2):129-34.
Weinberg DS, Inturrisi CE, Reidenberg B, Moulin DE, Nip TJ, Wallenstein S, et al. Sublingual absorption of selected opioid analgesics. Clin Pharmacol Ther. 1988;44(3):335-42.
Lennernas B, Hedner T, Holmberg M, Bredenberg S, Nystrom C, Lennernas H. Pharmacokinetics and tolerability of different doses of fentanyl following sublingual administration of a rapidly dissolving tablet to cancer patients: a new approach to treatment of incident pain. Br J Clin Pharmacol. 2005;59(2):249-53.
Manirakiza A, Irakoze L, Manirakiza S, Bizimana P. Efficacy and Safety of Fentanyl Compared With Morphine among Adult Patients with Cancer: A Meta-Analysis. East Afr Health Res J. 2020;4(1):8-16.
Janknegt R, van den Beuken M, Schiere S, Uberall M, Knaggs R, Hanley J, et al. Rapid acting fentanyl formulations in breakthrough pain in cancer. Drug selection by means of the System of Objectified Judgement Analysis. Eur. J Hosp Pharm. 2018;25(3):e2.
Goldstein EJC, Citron DM, Tyrrell KL, Leoncio E. In vitro stability of three oral vancomycin preparations stored at 2-5 degrees C and ambient room temperature for up to 60 days against 100 Clostridioides (Clostridium) difficile and 51Staphylococcus aureus strains. Anaerobe. 2018;52:83-5.
Bushnaq M, Al-Shoubaki M, Milhem M. The feasibility of using intravenous fentanyl as sublingual drops in the treatment of incidental pain in patients with cancer. J Palliat Med. 2009;12(6):511-4.
Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332.
Mercadante S, Adile C, Cuomo A, Aielli F, Cortegiani A, Casuccio A, et al. 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. J Pain Symptom Manage. 2015;50(5):579-86.
Zecca E, Brunelli C, Centurioni F, Manzoni A, Pigni A, Caraceni A. Fentanyl sublingual tablets versus subcutaneous morphine for the management of severe cancer pain episodes in patients receiving opioid treatment: a double-blind, randomized noninferiority trial. J Clin Oncol. 2017;35(7):759-65.
Mercadante S, Prestia G, Casuccio A. The use of sublingual fentanyl for breakthrough pain by using doses proportional to opioid basal regimen. Curr Med Res Opin. 2013;29(11):1527-32.
Hashemi M, Zali A, Golmakani E, Delshad MH, Shadnoush M, Akbari ME. 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. 2021;29(1):51-9.