Oral Analgesics Utilization for Children With Musculoskeletal Injury (OUCH Trial): An RCT
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....
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Published in | Pediatrics (Evanston) Vol. 140; no. 5 |
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Main Authors | , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
01.11.2017
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Subjects | |
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Abstract | 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.
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.
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 (
= .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) (
= .69). Children in the morphine + ibuprofen group (
< .001) and in the morphine group (
< .001) experienced more side effects than those in the ibuprofen group. No serious adverse event was reported.
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). |
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AbstractList | 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.
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.
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 (
= .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) (
= .69). Children in the morphine + ibuprofen group (
< .001) and in the morphine group (
< .001) experienced more side effects than those in the ibuprofen group. No serious adverse event was reported.
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). |
Author | Ballard, Ariane Auclair, Marie-Christine Mâsse, Benoit Parent, Stefan Ali, Samina Plint, Amy C Khadra, Christelle Neto, Gina Villeneuve, Edith Leclair, Grégoire Drendel, Amy L Le May, Sylvie McGrath, Patrick J Gouin, Serge |
Author_xml | – sequence: 1 givenname: Sylvie surname: Le May fullname: Le May, Sylvie email: sylvie.lemay@umontreal.ca organization: CHU Sainte-Justine Research Center, Montreal, Quebec, Canada – sequence: 2 givenname: Samina surname: Ali fullname: Ali, Samina organization: Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada – sequence: 3 givenname: Amy C surname: Plint fullname: Plint, Amy C organization: Emergency Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada – sequence: 4 givenname: Benoit surname: Mâsse fullname: Mâsse, Benoit organization: CHU Sainte-Justine Research Center, Montreal, Quebec, Canada – sequence: 5 givenname: Gina surname: Neto fullname: Neto, Gina organization: Emergency Department, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada – sequence: 6 givenname: Marie-Christine surname: Auclair fullname: Auclair, Marie-Christine organization: CHU Sainte-Justine Research Center, Montreal, Quebec, Canada – sequence: 7 givenname: Amy L surname: Drendel fullname: Drendel, Amy L organization: Emergency Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin – sequence: 8 givenname: Ariane surname: Ballard fullname: Ballard, Ariane organization: Women and Children's Health Research Institute, Edmonton, Alberta, Canada – sequence: 9 givenname: Christelle surname: Khadra fullname: Khadra, Christelle organization: Women and Children's Health Research Institute, Edmonton, Alberta, Canada – sequence: 10 givenname: Edith surname: Villeneuve fullname: Villeneuve, Edith organization: Departments of Anesthesia and – sequence: 11 givenname: Stefan surname: Parent fullname: Parent, Stefan organization: Surgery, and – sequence: 12 givenname: Patrick J surname: McGrath fullname: McGrath, Patrick J organization: IWK Health Centre, Nova Scotia Health Authority and Dalhousie University, Halifax, Nova Scotia, Canada – sequence: 13 givenname: Grégoire surname: Leclair fullname: Leclair, Grégoire organization: Pharmacy, University of Montreal, Montreal, Quebec, Canada – sequence: 14 givenname: Serge surname: Gouin fullname: Gouin, Serge organization: Division of Emergency Medicine, Department of Pediatrics, CHU Sainte-Justine, Montreal, Quebec, Canada; and |
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Copyright | Copyright © 2017 by the American Academy of Pediatrics. |
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References | 30032108 - Evid Based Nurs. 2018 Oct;21(4):107 |
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Snippet | Musculoskeletal injuries (MSK-Is) are a common and painful condition among children that remains poorly treated in the emergency department (ED). We aimed to... |
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SubjectTerms | Administration, Oral Adolescent Analgesics - administration & dosage Analgesics, Opioid - administration & dosage Anti-Inflammatory Agents, Non-Steroidal - administration & dosage Child Double-Blind Method Drug Therapy, Combination Female Humans Ibuprofen - administration & dosage Male Morphine - administration & dosage Musculoskeletal Diseases - diagnosis Musculoskeletal Diseases - drug therapy Pain Management - methods Pain Measurement - drug effects Pain Measurement - methods |
Title | Oral Analgesics Utilization for Children With Musculoskeletal Injury (OUCH Trial): An RCT |
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