Status:
NOT_YET_RECRUITING
Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Hamilton Health Sciences Corporation
Conditions:
Musculoskeletal Injury
Pediatrics
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
Brief Summary
The TOP-MAP pilot trial has multiple goals. The first goal of this pilot clinical trial is to find out if it will be possible to carry out a study at multiple pediatric emergency department sites (Ped...
Detailed Description
In Canada, musculoskeletal sprains and strains account for 10% of Emergency department visits in children aged 10-17 years of age. Unlike upper limb injuries, which are often fractured, injuries to th...
Eligibility Criteria
Inclusion
- Age 6 to 18 years old.
- Injury less than or equal to 4 days old
- Non-fractured MSK soft-tissue injury (ankle or knee, confirmed clinically and/or radiographically)
- Pain score of more than or equal to 3 on the verbal numerical rating scale, with movement in the past 2 hours or before analgesia
Exclusion
- Previous enrolment in the trial
- Barriers to topical treatment application, including skin conditions (e.g. eczema, infection, open wounds) or overlying material (e.g., rigid cast) which would make applying topical treatment impossible.
- Any other history, condition, therapy, or uncontrolled intercurrent illness, which could, in the opinion of the Qualified Medical Investigator or treating physician, would make the participant unsuitable for this study
- Any contraindication to NSAID use including but not limited to a history of GI bleeding, gastric ulcer, inflammatory bowel disease, prior cerebrovascular bleeding, bleeding diathesis, interstitial kidney disease
- Taking NSAIDs daily for other indications (e.g, chronic pain or arthritis)
- Known hypersensitivity to ibuprofen, diclofenac or other NSAIDs.
- Any known allergy or intolerance to any components (e.g., aloe vera) included in the oral or topical preparations of the investigational products
- Current use of prohibited medications known to impair renal function when combined with NSAIDs or cause potential additive risks of gastrointestinal toxicity and renal impairment
- Absence of a parent/guardian for children who are not mature minors.
- Caregiver and/or child cognitive impairment precluding the ability to complete study procedures
- Inability to obtain consent, and to complete follow-up surveys due to language barrier
- Known or suspected late pregnancy (gestational age ≥20 weeks) at the time of enrolment or breastfeeding females, due to the risk of premature closure of the ductus arteriosus associated with NSAID use
- Current enrollment in another pain-related clinical trial or in a study that, in the opinion of the Qualified Medical Investigator, may interfere with enrollment, involve investigational products that interact with study medications, or compromise follow-up and outcome assessment
Key Trial Info
Start Date :
September 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07145645
Start Date
September 2 2025
End Date
March 31 2028
Last Update
August 28 2025
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