Sylvie Le May1,2, Samina Ali3,4, Amy C Plint5,6, Benoit Mâsse2, Gina Neto7, Marie-Christine Auclair2, Amy L Drendel5,8, Ariane Ballard9,2,3, Christelle Khadra9,2,3, Edith Villeneuve10, Stefan Parent11, Patrick J McGrath12, Grégoire Leclair13, Serge Gouin14. 1. Faculties of Nursing and sylvie.lemay@umontreal.ca. 2. CHU Sainte-Justine Research Center, Montreal, Quebec, Canada. 3. Women and Children's Health Research Institute, Edmonton, Alberta, Canada. 4. Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada. 5. Departments of Pediatrics and. 6. Emergency Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada. 7. Emergency Department, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada. 8. Emergency Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin. 9. Faculties of Nursing and. 10. Departments of Anesthesia and. 11. Surgery, and. 12. IWK Health Centre, Nova Scotia Health Authority and Dalhousie University, Halifax, Nova Scotia, Canada. 13. Pharmacy, University of Montreal, Montreal, Quebec, Canada. 14. Division of Emergency Medicine, Department of Pediatrics, CHU Sainte-Justine, Montreal, Quebec, Canada; and.
Abstract
BACKGROUND:Musculoskeletal injuries (MSK-Is) are a common and painful condition among children that remains poorly treated in the emergency department (ED). We aimed to test the efficacy of a combination of an anti-inflammatory drug with an opioid for pain management of MSK-I in children presenting to the ED. METHODS: In this randomized, double-blinded, placebo-controlled trial, we enrolled children between 6 and 17 years presenting to the ED with an MSK-I and a pain score >29 mm on the visual analog scale (VAS). Participants were randomly assigned to oral morphine (0.2 mg/kg) + ibuprofen (10 mg/kg) (morphine + ibuprofen) or morphine (0.2 mg/kg) + placebo of ibuprofen or ibuprofen (10 mg/kg) + placebo of morphine. Primary outcome was children with VAS pain score <30 mm at 60 minutes postmedication administration. RESULTS:A total of 501 participants were enrolled and 456 were included in primary analyses (morphine + ibuprofen = 177; morphine = 188; ibuprofen = 91). Only 29.9% (morphine + ibuprofen), 29.3% (morphine), and 33.0% (ibuprofen) of participants achieved the primary outcome (P = .81). Mean VAS pain reduction at 60 minutes were -18.7 (95% confidence interval [CI]: -21.9 to -16.6) (morphine + ibuprofen), -17.0 (95% CI: -20.0 to -13.9) (morphine), -18.6 (95% CI: -22.9 to -14.2) (ibuprofen) (P = .69). Children in the morphine + ibuprofen group (P < .001) and in the morphine group (P < .001) experienced more side effects than those in the ibuprofen group. No serious adverse event was reported. CONCLUSIONS: Combination of morphine with ibuprofen did not provide adequate pain relief for children with MSK-I in the ED. None of the study medication provided an optimal pain management because most of children did not reach a mild pain score (NCT02064894).
RCT Entities:
BACKGROUND:Musculoskeletal injuries (MSK-Is) are a common and painful condition among children that remains poorly treated in the emergency department (ED). We aimed to test the efficacy of a combination of an anti-inflammatory drug with an opioid for pain management of MSK-I in children presenting to the ED. METHODS: In this randomized, double-blinded, placebo-controlled trial, we enrolled children between 6 and 17 years presenting to the ED with an MSK-I and a pain score >29 mm on the visual analog scale (VAS). Participants were randomly assigned to oral morphine (0.2 mg/kg) + ibuprofen (10 mg/kg) (morphine + ibuprofen) or morphine (0.2 mg/kg) + placebo of ibuprofen or ibuprofen (10 mg/kg) + placebo of morphine. Primary outcome was children with VAS pain score <30 mm at 60 minutes postmedication administration. RESULTS: A total of 501 participants were enrolled and 456 were included in primary analyses (morphine + ibuprofen = 177; morphine = 188; ibuprofen = 91). Only 29.9% (morphine + ibuprofen), 29.3% (morphine), and 33.0% (ibuprofen) of participants achieved the primary outcome (P = .81). Mean VAS pain reduction at 60 minutes were -18.7 (95% confidence interval [CI]: -21.9 to -16.6) (morphine + ibuprofen), -17.0 (95% CI: -20.0 to -13.9) (morphine), -18.6 (95% CI: -22.9 to -14.2) (ibuprofen) (P = .69). Children in the morphine + ibuprofen group (P < .001) and in the morphine group (P < .001) experienced more side effects than those in the ibuprofen group. No serious adverse event was reported. CONCLUSIONS: Combination of morphine with ibuprofen did not provide adequate pain relief for children with MSK-I in the ED. None of the study medication provided an optimal pain management because most of children did not reach a mild pain score (NCT02064894).
Authors: Samina Ali; Manasi Rajagopal; Terry Klassen; Lawrence Richer; Christopher McCabe; Andy Willan; Maryna Yaskina; Anna Heath; Amy L Drendel; Martin Offringa; Serge Gouin; Antonia Stang; Scott Sawyer; Maala Bhatt; Serena Hickes; Naveen Poonai Journal: BMJ Open Date: 2020-06-21 Impact factor: 2.692
Authors: Anna Heath; Maryna Yaskina; Gareth Hopkin; Terry P Klassen; Christopher McCabe; Martin Offringa; Petros Pechlivanoglou; Juan David Rios; Naveen Poonai; Samina Ali Journal: Trials Date: 2020-09-03 Impact factor: 2.279
Authors: Mohamed Eltorki; Jason W Busse; Stephen B Freedman; Graham Thompson; Karen Beattie; Claudiu Serbanescu; Redjana Carciumaru; Lehana Thabane; Samina Ali Journal: BMJ Open Date: 2022-04-05 Impact factor: 2.692