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)

• Published in: BMJ open 2020-06, Vol.10 (6), p.e035177-e035177
• Main Authors: Ali, Samina, Rajagopal, Manasi, Klassen, Terry, Richer, Lawrence, McCabe, Christopher, Willan, Andy, Yaskina, Maryna, Heath, Anna, Drendel, Amy L, Offringa, Martin, Gouin, Serge, Stang, Antonia, Sawyer, Scott, Bhatt, Maala, Hickes, Serena, Poonai, Naveen
• Format: Article
• Language: English
• Subjects: Acetaminophen - therapeutic use; Adolescent; Analgesics; Analgesics, Non-Narcotic - therapeutic use; Analgesics, Opioid - therapeutic use; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Canada; Caregivers; Child; Child abuse & neglect; Children; Children & youth; Clinical decision making; Clinical trials; Cognitive ability; Decision making; Double-blind studies; Emergency Service, Hospital; Emergency services; Equivalence Trials as Topic; Ethics; Extremities - injuries; Families & family life; Health research; Humans; Hydromorphone - therapeutic use; Ibuprofen - therapeutic use; Informed consent; Injuries; Morphine; Multicenter Studies as Topic; Musculoskeletal Pain - drug therapy; Narcotics; Nonsteroidal anti-inflammatory drugs; Opioids; Paediatrics; Pain; Pain management; Pain Management - methods; Parents & parenting; Pediatrics; Recruitment; Research Design; Research ethics; Trauma
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2019-035177

IntroductionMusculoskeletal (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 analysisUsing 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 disseminationThis 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 numberNCT03767933, first registered on 07 December 2018.