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)

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, KidsCAN PERC Innovative Pediatric Clinical Trials No OUCH Study Team, 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, KidsCAN PERC Innovative Pediatric Clinical Trials No OUCH Study Team

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.

Keywords: accident & emergency medicine; paediatric orthopaedics; pain management.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study interventions.
Figure 2
Figure 2
Schedule of study measures. BP, blood pressure; ED, emergency department; FPS-R, Faces Pain Scale-Revised; HR, heart rate; O2 sat, oxygensaturation; RR, respiratory rate; RSS, RamsaySedation Scale; T-ME, time of medical examination; T-R, time ofrecruitment; T-XR, time following X-ray; T-0, timeof study drug administration; T-30, T-60, T-90, T-120, 30 min,60 min, 90 minand 120 min, respectively; vNRS, verbal Numerical Rating Scale; VAS, VisualAnalogue Scale.

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Source: PubMed

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