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).
Acetaminophen
/ therapeutic use
Adolescent
Analgesics, Non-Narcotic
/ therapeutic use
Analgesics, Opioid
/ therapeutic use
Anti-Inflammatory Agents, Non-Steroidal
/ therapeutic use
Canada
Child
Emergency Service, Hospital
Equivalence Trials as Topic
Extremities
/ injuries
Humans
Hydromorphone
/ therapeutic use
Ibuprofen
/ therapeutic use
Multicenter Studies as Topic
Musculoskeletal Pain
/ drug therapy
Pain Management
/ methods
Research Design
accident & emergency medicine
paediatric orthopaedics
pain management
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
21 06 2020
21 06 2020
Historique:
entrez:
23
6
2020
pubmed:
23
6
2020
medline:
16
2
2021
Statut:
epublish
Résumé
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. 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. 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. NCT03767933, first registered on 07 December 2018.
Identifiants
pubmed: 32565458
pii: bmjopen-2019-035177
doi: 10.1136/bmjopen-2019-035177
pmc: PMC7311068
doi:
Substances chimiques
Analgesics, Non-Narcotic
0
Analgesics, Opioid
0
Anti-Inflammatory Agents, Non-Steroidal
0
Acetaminophen
362O9ITL9D
Hydromorphone
Q812464R06
Ibuprofen
WK2XYI10QM
Banques de données
ClinicalTrials.gov
['NCT03767933']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e035177Subventions
Organisme : CIHR
ID : MYG-151207
Pays : Canada
Informations de copyright
© 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.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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