Topical diclofenac gel versus oral ibuprofen for kids with ankle or knee sprains

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pilot, multicenter randomized interventional comparison of topical diclofenac emulgel versus oral ibuprofen in children 6–18 years with non-fractured ankle or knee soft-tissue injuries. Participants will use the assigned medication three times daily and complete follow-up questionnaires over 14 days to measure pain control, adherence, and adverse events. The pilot is designed to determine feasibility for a larger non-inferiority trial, including recruitment, adherence to treatments, and data completeness. Outcomes will focus on pain reduction with movement and the frequency of systemic adverse effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 6 to 18 years old.
2. Injury less than or equal to 4 days old
3. Non-fractured MSK soft-tissue injury (ankle or knee, confirmed clinically and/or radiographically)
4. 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
5. Willing and able to complete follow-up surveys as per study protocol

Exclusion Criteria:

1. Previous enrolment in the trial
2. 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.
3. 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
4. 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
5. Taking NSAIDs daily for other indications (e.g, chronic pain or arthritis)
6. Known hypersensitivity to ibuprofen, diclofenac or other NSAIDs.
7. Any known allergy or intolerance to any components or trace constituents (e.g., aloe vera, tree nuts or corn) of the investigational products
8. 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
9. Absence of a parent/guardian for children who are not mature minors.
10. Caregiver and/or child cognitive impairment precluding the ability to complete study procedures
11. Inability to obtain consent, and to complete follow-up surveys due to language barrier
12. 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
13. 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

Where it's running

• Alberta Children's Hospital
  Calgary, Alberta, Canada Recruiting
• Stollery Children's Hospital
  Edmonton, Alberta, Canada Not yet recruiting

Study contacts

• Principal investigator: Mohamed M Eltorki, MBChB, MSc — University of Calgary
• Study coordinator: Mohamed M Eltorki, MBChB, MSc
• Email: mmeltork@ucalgary.ca
• Phone: 403-955-7723

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.