Status:
COMPLETED
Non-Steroidal or Opioid Analgesia Use for Children With Musculoskeletal Injuries
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
University of Manitoba
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Musculoskeletal Injury
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
Musculoskeletal (MSK) injuries, including limb injuries, are the most common cause for Emergency Department (ED) visits for children with pain. Broken arms and legs are known to cause moderate to seve...
Detailed Description
Rationale: Multiple national and international organizations, including the American Academy of Pediatrics (AAP), have voiced concern over the emergency departments' (EDs) ability and willingness to ...
Eligibility Criteria
Inclusion
- Child aged 6-17 years
- Presenting to the emergency department with an acute limb injury (\<24 hours old) that is neither obviously deformed nor having neuro-vascular compromise (as assessed by the triage nurse)
- Self-reported pain score \> 5 on the 0 to 10 verbal Numerical Rating Scale at triage
Exclusion
- Deemed to require immediate intravenous (IV) or intranasal (IN) pain medications by the clinical team
- Previously known hypersensitivity to study medications
- Acetaminophen or NSAID use within 3 hours prior to recruitment
- Opioid use within 1 hour prior to recruitment
- Caregiver and/or child cognitive impairment precluding the ability to self-report pain or respond to study questions
- Injury suspected to be due to non-accidental trauma/ child abuse (as assessed by the triage nurse or reported by the family)
- Suspected multi-limb fracture
- Chronic pain that necessitates daily analgesic use
- Hepatic or renal disease/dysfunction
- Bleeding disorder
- Known pregnancy
- Vomiting that precludes the ability to take oral medications (as determined by the family)
- Caregiver and/or child inability to communicate fluently in English or French in the absence of a native language interpreter
- Caregiver unavailable for follow-up
- Previous enrolment in the NO OUCH study
Key Trial Info
Start Date :
April 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2023
Estimated Enrollment :
710 Patients enrolled
Trial Details
Trial ID
NCT03767933
Start Date
April 20 2019
End Date
March 22 2023
Last Update
September 19 2024
Active Locations (6)
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1
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A9
2
Stollery Children's Hospital Emergency Department
Edmonton, Alberta, Canada, T6G 2B7
3
Children's Hospital of Winnipeg
Winnipeg, Manitoba, Canada, R3A 1S1
4
Childrens Hospital at London Health Sciences
London, Ontario, Canada, N6A 5W9