Study protocol for two complementary trials of non-steroidal or opioid analgesia use for children aged 6 to 17 years with musculoskeletal injuries (the No OUCH study)

Authors

Samina Ali, University of Alberta, Faculty of Medicine and Dentistry
Manasi Rajagopal, University of Alberta, Faculty of Medicine and Dentistry
Terry Klassen, University of Manitoba
Lawrence Richer, University of Alberta, Faculty of Medicine and Dentistry
Christopher McCabe, University of Alberta
Andy Willan, University of Toronto
Maryna Yaskina, University of Alberta
Anna Heath, University of Toronto
Amy L. Drendel, Medical College of Wisconsin
Martin Offringa, Hospital for Sick Children University of Toronto
Serge Gouin, University of Montreal
Antonia Stang, University of Calgary
Antonia Stang, University of Calgary
Scott Sawyer, University of Manitoba
Maala Bhatt, University of Ottawa
Maala Bhatt, University of Ottawa
Serena Hickes, University of Manitoba
Naveen Poonai, London Health Sciences CentreFollow

Document Type

Article

Publication Date

6-21-2020

Journal

BMJ Open

Volume

10

Issue

6

URL with Digital Object Identifier

10.1136/bmjopen-2019-035177

Abstract

Introduction Musculoskeletal (MSK) injuries are a frequent cause for emergency department (ED) visits in children. MSK injuries are associated with moderate-to-severe pain in most children, yet recent research confirms that the management of children's pain in the ED remains inadequate. Clinicians are seeking better oral analgesic options for MSK injury pain with demonstrated efficacy and an excellent safety profile. This study aims to determine the efficacy and safety of adding oral acetaminophen or oral hydromorphone to oral ibuprofen and interpret this information within the context of parent/caregiver preference. Methods and analysis Using a novel preference-informed complementary trial design, two simultaneous trials are being conducted. Parents/caregivers of children presenting to the ED with acute limb injury will be approached and they will decide which trial they wish to participate in: an opioid-inclusive trial or a non-opioid trial. Both trials will follow randomised, double-blind, placebo-controlled, superiority-trial methodology and will enrol a minimum of 536 children across six Canadian paediatric EDs. Children will be eligible if they are 6 to 17 years of age and if they present to the ED with an acute limb injury and a self-reported verbal Numerical Rating Scale pain score ≥5. The primary objective is to determine the effectiveness of oral ibuprofen+oral hydromorphone versus oral ibuprofen+oral acetaminophen versus oral ibuprofen alone. Recruitment was launched in April 2019. Ethics and dissemination This study has been approved by the Health Research Ethics Board (University of Alberta), and by appropriate ethics boards at all recruiting centres. Informed consent will be obtained from parents/guardians of all participants, in conjunction with assent from the participants themselves. Study data will be submitted for publication regardless of results. This study is funded through a Canadian Institutes of Health Research grant. Trial registration number NCT03767933, first registered on 07 December 2018.