Inhaled methoxyflurane for the management of trauma related pain in patients admitted to hospital emergency departments: a randomised, double-blind placebo-controlled trial (PenASAP study).
Journal
European journal of emergency medicine : official journal of the European Society for Emergency Medicine
ISSN: 1473-5695
Titre abrégé: Eur J Emerg Med
Pays: England
ID NLM: 9442482
Informations de publication
Date de publication:
Dec 2020
Dec 2020
Historique:
pubmed:
14
4
2020
medline:
28
5
2021
entrez:
14
4
2020
Statut:
ppublish
Résumé
Oligo-analgesia is common in the emergency department (ED). This study aimed at reporting, when initiated by triage nurse, the superior efficacy of inhaled methoxyflurane plus standard of care (m-SoC) analgesia versus placebo plus SoC (p-SoC) for moderate-to-severe trauma-related pain in the hospital ED. A randomised, double-blind, placebo-controlled trial was conducted at eight EDs. Adults with pain score ≥4 (11-point numerical rate scale, NRS) at admission were randomised to receive one or two inhalers containing m-SoC or p-SoC. Primary outcome measure was time until pain relief ≤30 mm, assessed on the 100-mm Visual Analogic Scale (VAS). A total of 351 patients were analysed (178 m-SoC; 173 p-SoC). Median pain prior to first inhalation was 66 mm, 75% had severe pain (NRS 6-10). Median time to pain relief was 35 min [95% confidence interval (CI), 28-62] for m-SoC versus not reached in p-SoC (92 - not reached) [hazard ratio), 1.93 (1.43-2.60), P < 0.001]. Pain relief was most pronounced in the severe pain subgroup: hazard ratio, 2.5 (1.7-3.7). As SoC, 24 (7%) patients received weak opioids (6 versus 8%), 4 (1%) strong opioid and 44 (13%) escalated to weak or strong opioids (8 versus 17%, respectively, P = 0.02). Most adverse events were of mild (111/147) intensity. In this study, we report that methoxyflurane, initiated at triage nurse as part of a multimodal analgesic approach, is effective in achieving pain relief for trauma patients. This effect was particularly pronounced in the severe pain subgroup.
Sections du résumé
BACKGROUND
BACKGROUND
Oligo-analgesia is common in the emergency department (ED). This study aimed at reporting, when initiated by triage nurse, the superior efficacy of inhaled methoxyflurane plus standard of care (m-SoC) analgesia versus placebo plus SoC (p-SoC) for moderate-to-severe trauma-related pain in the hospital ED.
METHODS
METHODS
A randomised, double-blind, placebo-controlled trial was conducted at eight EDs. Adults with pain score ≥4 (11-point numerical rate scale, NRS) at admission were randomised to receive one or two inhalers containing m-SoC or p-SoC. Primary outcome measure was time until pain relief ≤30 mm, assessed on the 100-mm Visual Analogic Scale (VAS).
RESULTS
RESULTS
A total of 351 patients were analysed (178 m-SoC; 173 p-SoC). Median pain prior to first inhalation was 66 mm, 75% had severe pain (NRS 6-10). Median time to pain relief was 35 min [95% confidence interval (CI), 28-62] for m-SoC versus not reached in p-SoC (92 - not reached) [hazard ratio), 1.93 (1.43-2.60), P < 0.001]. Pain relief was most pronounced in the severe pain subgroup: hazard ratio, 2.5 (1.7-3.7). As SoC, 24 (7%) patients received weak opioids (6 versus 8%), 4 (1%) strong opioid and 44 (13%) escalated to weak or strong opioids (8 versus 17%, respectively, P = 0.02). Most adverse events were of mild (111/147) intensity.
CONCLUSIONS
CONCLUSIONS
In this study, we report that methoxyflurane, initiated at triage nurse as part of a multimodal analgesic approach, is effective in achieving pain relief for trauma patients. This effect was particularly pronounced in the severe pain subgroup.
Identifiants
pubmed: 32282467
doi: 10.1097/MEJ.0000000000000686
pii: 00063110-202012000-00011
doi:
Substances chimiques
Analgesics, Opioid
0
Anesthetics, Inhalation
0
Methoxyflurane
30905R8O7B
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
414-421Références
Panorama of the DREES. Health facilities. 2018. https://drees.solidarites-sante.gouv.fr/etudes-et-statistiques/publications/panoramas-de-la-drees/article/les-etablissements-de-sante-edition-2018. [Accessed 29 july 2019]
Galinski M, Ruscev M, Gonzalez G, Kavas J, Ameur L, Biens D, et al. Prevalence and management of acute pain in prehospital emergency medicine. Prehosp Emerg Care. 2010; 14:334–339
Berben SA, Schoonhoven L, Meijs TH, van Vugt AB, van Grunsven PM. Prevalence and relief of pain in trauma patients in emergency medical services. Clin J Pain. 2011; 27:587–592
Berben SA, Meijs TH, van Dongen RT, van Vugt AB, Vloet LC, Mintjes-de Groot JJ, van Achterberg T. Pain prevalence and pain relief in trauma patients in the Accident & Emergency department. Injury. 2008; 39:578–585
Vivien B, Adnet F, Bounes V. Formalised recommendations of experts 2010: sedation and analgesia in an emergency structure (update of the Conference of experts of the SFAR of 1999). Ann. Fr. Med. Urgence. 2011; 1:57–71
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
Guéant S, Taleb A, Borel-Kühner J, Cauterman M, Raphael M, Nathan G, Ricard-Hibon A. Quality of pain management in the emergency department: results of a multicentre prospective study. Eur J Anaesthesiol. 2011; 28:97–105
Pines JM, Hollander JE. Emergency department crowding is associated with poor care for patients with severe pain. Ann Emerg Med. 2008; 51:1–5
Todd KH, Ducharme J, Choiniere M, Crandall CS, Fosnocht DE, Homel P, Tanabe P; PEMI Study Group. Pain in the emergency department: results of the pain and emergency medicine initiative (PEMI) multicenter study. J Pain. 2007; 8:460–466
Porter KM, Dayan AD, Dickerson S, Middleton PM. The role of inhaled methoxyflurane in acute pain management. Open Access Emerg Med. 2018; 10:149–164
Coffey F, Wright J, Hartshorn S, Hunt P, Locker T, Mirza K, Dissmann P. 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; 31:613–618
Coffey F, Dissmann P, Mirza K, Lomax M. Methoxyflurane analgesia in adult patients in the emergency department: a subgroup analysis of a randomized, double-blind, placebo-controlled study (STOP!). Adv Ther. 2016; 33:2012–2031
Hwang U, Richardson LD, Sonuyi TO, Morrison RS. The effect of emergency department crowding on the management of pain in older adults with hip fracture. J Am Geriatr Soc. 2006; 54:270–275
Blair HA, Frampton JE. Methoxyflurane: a review in trauma pain. Clin Drug Investig. 2016; 36:1067–1073
Blair HA, Frampton JE. Methoxyflurane inhalation vapour in trauma pain: a profile of its use in the EU. Drugs Ther Perspect. 2017; 33:403
Buntine P, Thom O, Babl F, Bailey M, Bernard S. Prehospital analgesia in adults using inhaled methoxyflurane. Emerg Med Australas. 2007; 19:509–514
Middleton PM, Simpson PM, Sinclair G, Dobbins TA, Math B, Bendall JC. Effectiveness of morphine, fentanyl, and methoxyflurane in the prehospital setting. Prehosp Emerg Care. 2010; 14:439–447
Gillis M, Keirens A, Steinkamm C. The use of methoxyflurane (Penthrox) in the emergency department. Reg Anesth Pain Med. 2008; 33Suppl 1e247
Oxer HF, Wilkes G. Methoxyflurane is a safe, easy, effective analgesic for prehospital pain relief. Prehosp Disaster Med. 2007; 22:s77
Babl F, Barnett P, Palmer G, Oakley E, Davidson A. A pilot study of inhaled methoxyflurane for procedural analgesia in children. Paediatr Anaesth. 2007; 17:148–153
Babl FE, Jamison SR, Spicer M, Bernard S. Inhaled methoxyflurane as a prehospital analgesic in children. Emerg Med Australas. 2006; 18:404–410
Bendall JC, Simpson PM, Middleton PM. Effectiveness of prehospital morphine, fentanyl, and methoxyflurane in pediatric patients. Prehosp Emerg Care. 2011; 15:158–165
Chin R, Maccaskill M, Browne G. A randomised control trial of inhaled methoxyflurane pain relief, in children with upper limb fracture. J Paediatr Child Health. 2002; 38:A13
Viglino D, Termoz Masson N, Verdetti A, Champel F, Falcon C, Mouthon A, et al. Multimodal oral analgesia for non-severe trauma patients: evaluation of a triage-nurse directed protocol combining methoxyflurane, paracetamol and oxycodone. Intern Emerg Med. 2019; 14:1139–1145
Borobia AM, Collado SG, Carballo CC, Pueyo RC, Alonso CF, Torres IP, et al. Inhaled methoxyflurane provides greater analgesia and faster onset action versus standard analgesia in patients with trauma pain: InMEDIATE: a randomized controlled trial in Emergency Departments. Ann Emerg Med. 2020; 75:315–328
Mercadante S, Voza A, Serra S, Ruggiano G, Carpinteri G, Gangitano G, et al.; MEDITA Study Group. Analgesic efficacy, practicality and safety of inhaled methoxyflurane versus standard analgesic treatment for acute trauma pain in the emergency setting: a randomised, open-label, active-controlled, multicentre trial in italy (MEDITA). Adv Ther. 2019; 36:3030–3046
Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001; 94:149–158
Albrecht E, Taffe P, Yersin B, Schoettker P, Decosterd I, Hugli O. Undertreatment of acute pain (oligoanalgesia) and medical practice variation in prehospital analgesia of adult trauma patients: a 10 yr retrospective study. Br J Anaesth. 2013; 110:96–106