Rapid Administration of Methoxyflurane to Patients in the Emergency Department (RAMPED) Study: A Randomized Controlled Trial of Methoxyflurane Versus Standard Care.
Journal
Academic emergency medicine : official journal of the Society for Academic Emergency Medicine
ISSN: 1553-2712
Titre abrégé: Acad Emerg Med
Pays: United States
ID NLM: 9418450
Informations de publication
Date de publication:
02 2021
02 2021
Historique:
received:
21
05
2020
revised:
04
09
2020
accepted:
16
09
2020
pubmed:
30
9
2020
medline:
19
3
2021
entrez:
29
9
2020
Statut:
ppublish
Résumé
The objective was to evaluate the effectiveness of methoxyflurane versus standard care for the initial management of severe pain among adult emergency department (ED) patients. This randomized parallel-group open-label phase IV trial of methoxyflurane was conducted in a tertiary hospital ED setting in Australia. Inclusion criteria required adult patients to have an initial pain score ≥ 8 on the 11-point Numerical Rating Scale (NRS). Patients were randomized 1:1 to receive either inhaled methoxyflurane (3 mL) or standard analgesic treatment at ED triage. The primary outcome was the proportion of patients achieving clinically substantial pain reduction, defined as a ≥50% drop in the pain score at 30 minutes. Secondary outcomes included the pain score at multiple time points (15, 30, 60, 90 minutes) and the difference in the proportion of patients achieving a >2-point reduction on the NRS. There were 120 patients randomized and analyzed between September 4, 2019, and January 16, 2020. The primary outcome was achieved in six (10%) patients in the methoxyflurane arm and three (5%) in the standard care arm (p = 0.49). A higher proportion of patients in the methoxyflurane arm reported a >2-point drop on the NRS at all time points (17% vs. 5% at 15 minutes, 25% vs. 9% at 30 minutes, 30% vs. 10% at 60 minutes, and 33% vs. 13% at 90 minutes). Methoxyflurane use was also associated with lower median pain scores at all time points. Initial management with inhaled methoxyflurane in the ED did not achieve the prespecified substantial reduction in pain, but was associated with clinically significant lower pain scores compared to standard therapy.
Substances chimiques
Anesthetics, Inhalation
0
Methoxyflurane
30905R8O7B
Banques de données
ANZCTR
['ANZCTR1262000004294']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
164-171Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2020 by the Society for Academic Emergency Medicine.
Références
Stang AS, Hartling L, Fera C, Johnson D, Ali S. Quality indicators for the assessment and management of pain in the emergency department: a systematic review. Pain Res Manage 2014;19:e179-90.
New Zealand Emergency Medicine Network and The Shorter Stays in Emergency Department National Research Project Group. National audit of the quality of pain relief provided in emergency departments in Aotearoa, New Zealand: the PRiZED 1 study. Emerg Med Australas 2017;29:165-72.
Bennetts S, Campbell-Brophy E, Huckson S, Doherty S, National Health and Medical Research Council's National Institute for Clinical Studies National Emergency Care Pain Management Initiative. Pain management in Australian emergency departments: current practice, enablers, barriers and future directions. Emerg Med Australas 2012;24:136-43.
Pines JM, Hollander JE. Emergency department crowding is associated with poor care for patients with severe pain. Ann Emerg Med 2008;51:1-5.
Sokoloff C, Daoust R, Paquet J, Chauny JM. Is adequate pain relief and time to analgesia associated with emergency department length of stay? A retrospective study. BMJ Open 2014;4:e004288.
Kant J, Dombagolla M, Lai F, Hendarto A, Taylor DM. Analgesia in the emergency department: why is it not administered? Emerg Med J 2019;36:12-7.
Doherty S, Knott J, Bennetts S, Jazayeri M, Huckson S. National project seeking to improve pain management in the emergency department setting: findings from the NHMRC-NICS National Pain Management Initiative. Emerg Med Australas 2013;25:120-6.
Fry M, Bennetts S, Huckson S. An Australian audit of ED pain management patterns. J Emerg Nurs 2011;37:269-74.
Hatherley C, Jennings N, Cross R. Time to analgesia and pain score documentation best practice standards for the emergency department-a literature review. Australas Emerg Nurs J 2016;19:26-36.
Rahman SM, Quinn E. BET 1: green or blue for you? Methoxyflurane (Penthrox) or nitrous oxide/oxygen 50% mixture (Entonox) for the management of acute pain in the ED. Emerg Med J 2019;36:506-8.
Blair HA, Frampton JE. Methoxyflurane: a review in trauma pain. Clin Drug Invest 2016;36:1067-73.
Porter KM, Dayan AD, Dickerson S, Middleton PM. The role of inhaled methoxyflurane in acute pain management. Open Access Emerg Med 2018;10:149.
Hartshorn S, Barrett MJ, Lyttle MD, Yee SA, Irvine AT. Inhaled methoxyflurane (Penthrox) versus placebo for injury-associated analgesia in children-the MAGPIE trial (MEOF-002): study protocol for a randomised controlled trial. Trials 2019;20:393.
Dayan AD. Analgesic use of inhaled methoxyflurane: evaluation of its potential nephrotoxicity. Hum Exp Toxicol 2016;35:91-100.
Oxer HF. Effects of Penthrox (methoxyflurane) as an analgesic on cardiovascular and respiratory functions in the pre-hospital setting. J Milit Veterans Health 2016;24:14.
Borobia AM, Collado SG, Cardona CC, et al. Inhaled methoxyflurane provides greater analgesia and faster onset of action versus standard analgesia in patients with trauma pain: InMEDIATE: a randomized controlled trial in emergency departments. Ann Emerg Med 2020;75:315-28.
Buntine P, Thom O, Babl F, Bailey M, Bernard S. Prehospital analgesia in adults using inhaled methoxyflurane. Emerg Med Australas 2007;19:509-14.
Coffey F, Wright J, Hartshorn S, et al. STOP!: a randomised, double-blind, placebo-controlled study of the efficacy and safety of methoxyflurane for the treatment of acute pain. Emerg Med J 2014;31:613-8.
Fabbri A, Carpinteri G, Ruggiano G, et al. Methoxyflurane versus standard of care for acute trauma-related pain in the emergency setting: protocol for a randomised, controlled study in Italy (MEDITA). Adv Ther 2019;36:244-56.
Marinangeli F, Reggiardo G, Sblendido A, Soldi A, Farina A; METEORA Group. Prospective, multicentre trial of methoxyflurane for acute trauma-related pain in helicopter emergency medical systems and hostile environments: METEORA protocol. Adv Ther 2018;35:2081-92.
Australia New Zealand Clinical Trials Registry. Trial Review. Available at: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378966. Accessed Mar 11, 2020
Boonstra AM, Stewart RE, Köke AJ, et al. Cut-off points for mild, moderate, and severe pain on the numeric rating scale for pain in patients with chronic musculoskeletal pain: variability and influence of sex and catastrophizing. Front Psychol 2016;30:1466.
Penthrox Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/1939/smpc. Accessed Feb 27, 2020
Cepeda MS, Africano JM, Polo R, Alcala R, Carr DB. What decline in pain intensity is meaningful to patients with acute pain? Pain 2003;105:151-7.
Hartshorn S, Middleton PM. Efficacy and safety of inhaled low-dose methoxyflurane for acute paediatric pain: a systematic review. Trauma 2019;21:94-102.
Grindlay J, Babl FE. Efficacy and safety of methoxyflurane analgesia in the emergency department and prehospital setting. Emerg Med Australas 2009;21:4-11.
FitzGerald G, Jelinek GA, Scott D, Gerdtz MF. Emergency department triage revisited. Emerg Med J 2010;27:86-92.