Alberto M Borobia1, Sergio García Collado2, César Carballo Cardona3, Rosa Capilla Pueyo4, Cesáreo Fernández Alonso5, Ignacio Pérez Torres6, María Corell González7, José Ramón Casal Codesido8, María Arranz Betegón9, Luis Amador Barcela10, Aitor Odiaga Andicoechea11, Anselma Fernández Testa12, Jorge Trigo Colina13, Antonio Cid Dorribo14, Carmen Del Arco Galán15, Jose Carlos Martínez Ávila3, Susana Traseira Lugilde16, Antonio J Carcas Sansuán3. 1. Hospital Universitario La Paz, Madrid, Spain; School of Medicine, Universidad Autónoma de Madrid, Hospital La Paz Institute for Health Research, and Spanish Clinical Research Network, Madrid, Spain. Electronic address: alberto.borobia@salud.madrid.org. 2. Hospital Campo Grande, Valladolid, Spain. 3. Hospital Universitario La Paz, Madrid, Spain; School of Medicine, Universidad Autónoma de Madrid, Hospital La Paz Institute for Health Research, and Spanish Clinical Research Network, Madrid, Spain. 4. Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain. 5. Hospital Clínico San Carlos, Madrid, Spain. 6. Hospital Virgen del Rocío, Seville, Spain. 7. Hospital General de Alicante, Alicante, Spain. 8. Hospital el Bierzo, Ponferrada, Spain. 9. Hospital de Viladecans, Barcelona, Spain. 10. Hospital Universitario Álvaro Cunqueiro, Vigo, Spain. 11. Hospital Gernika-Lumo, Gernika-Lumo, Spain. 12. Complejo Asistencial de Zamora, Zamora, Spain. 13. Hospital Monográfico Asepeyo de traumatología, cirugía y rehabilitación, Coslada, Spain. 14. SUMMA 112, Madrid, Spain. 15. Hospital Universitario de La Princesa, Madrid, Spain. 16. Mundipharma Pharmaceuticals S.L., Madrid, Spain.
Abstract
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 2×3 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.
RCT Entities:
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 2×3 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.
Authors: Andrea Fabbri; Germana Ruggiano; Sergio Garcia Collado; Agnes Ricard-Hibon; Umberto Restelli; Giovanni Sbrana; Franco Marinangeli; Alberto Farina; Frank Coffey Journal: J Pain Res Date: 2020-06-25 Impact factor: 3.133
Authors: Andrea Fabbri; Alberto M Borobia; Agnes Ricard-Hibon; Frank Coffey; Aurore Caumont-Prim; François Montestruc; Amedeo Soldi; Susana Traseira Lugilde; Sara Dickerson Journal: J Pain Res Date: 2021-01-20 Impact factor: 3.133
Authors: Helmut Trimmel; Alexander Egger; Reinhard Doppler; Christoph Beywinkler; Wolfgang G Voelckel; Janett Kreutziger Journal: Anaesthesist Date: 2021-10-18 Impact factor: 1.041