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
Por:
Borobia, A, Collado, S, Cardona, C, Pueyo, R, Alonso, C, Torres, I, Gonzalez, M, Codesido, J, Betegon, M, Barcela, L, Andicoechea, A, Testa, A, Colina, J, Dorribo, A, Galan, C, Avila, J, Lugilde, S, Sansuan, A and InMEDIATE Investigators Grp
Publicada:
1 mar 2020
Ahead of Print:
14 oct 2019
Resumen:
Study objective: The objective of the InMEDIATE study was to evaluate the change in intensity of traumatic pain over the first 20 min in adult patients treated with methoxyflurane versus standard analgesic treatment in Spain. This the first randomized, active-controlled, multicenter trial of methoxyflurane in the emergency setting in Europe.
Methods: This was a randomized, controlled study that enrolled adult patients with acute moderate to severe (score >= 4 on the 11-point Numeric Rating Scale) trauma-associated pain in 14 Spanish emergency departments. Patients were randomized 1:1 to methoxyflurane (up to 2x3 mL) or standard analgesic treatment. Coprimary endpoints were the change from baseline in Numeric Rating Scale pain intensity score during the first 20 minutes of treatment and time to first pain relief.
Results: Three hundred five patients were randomized (methoxyflurane 156; standard analgesic treatment 149). Most patients in the standard analgesic treatment group (70%) received intravenous first-step analgesics and 9.4% of patients were treated with opioids. Mean decrease from baseline in Numeric Rating Scale pain intensity score was greater for methoxyflurane than standard analgesic treatment at all points, with a significant treatment difference overall up to 20 minutes (repeated-measures model 2.47 versus 1.39; treatment difference 1.00; 95% confidence interval 0.84 to 1.32). Median time to first pain relief was significantly shorter for methoxyflurane than standard analgesic treatment (3 versus 10 minutes). Methoxyflurane achieved better patient and clinician ratings for pain control and comfort of treatment than standard analgesic treatment and exceeded patient and clinician expectations of treatment in, respectively, 77% and 72% of cases compared with 38% and 19% for standard analgesic treatment.
Conclusion: These results support consideration of methoxyflurane as a nonnarcotic, easy-to-administer, rapid-acting, first-line alternative to currently available analgesic treatments for trauma pain.
Filiaciones:
Borobia, A:
Univ Autonoma Madrid, Hosp Univ La Paz, Sch Med, Hosp La Paz Inst Hlth Res, Madrid, Spain
Spanish Clin Res Network, Madrid, Spain
Collado, S:
Hosp Campo Grande, Valladolid, Spain
Cardona, C:
Univ Autonoma Madrid, Hosp Univ La Paz, Sch Med, Hosp La Paz Inst Hlth Res, Madrid, Spain
Spanish Clin Res Network, Madrid, Spain
Pueyo, R:
Hosp Univ Puerta Hierro Majadahonda, Madrid, Spain
Alonso, C:
Hosp Clin San Carlos, Madrid, Spain
Torres, I:
Hosp Virgen Rocio, Seville, Spain
:
Hosp Gen Alicante, Alicante, Spain
Codesido, J:
Hosp Bierzo, Ponferrada, Spain
Betegon, M:
Hosp Viladecans, Barcelona, Spain
Barcela, L:
Hosp Univ Alvaro Cunqueiro, Vigo, Spain
Andicoechea, A:
Hosp Gernika Lumo, Gernika Lumo, Spain
Testa, A:
Complejo Asistencial Zamora, Zamora, Spain
Colina, J:
Hosp Monograf Asepeyo Traumatol Cirugia & Rehabil, Coslada, Spain
Dorribo, A:
SUMMA 112, Madrid, Spain
Galan, C:
Hosp Univ La Princesa, Madrid, Spain
Avila, J:
Univ Autonoma Madrid, Hosp Univ La Paz, Sch Med, Hosp La Paz Inst Hlth Res, Madrid, Spain
Spanish Clin Res Network, Madrid, Spain
Lugilde, S:
Mundipharma Pharmaceut SL, Madrid, Spain
Sansuan, A:
Univ Autonoma Madrid, Hosp Univ La Paz, Sch Med, Hosp La Paz Inst Hlth Res, Madrid, Spain
Spanish Clin Res Network, Madrid, Spain
Green Published, hybrid
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