Topical diclofenac gel versus oral ibuprofen for kids with ankle or knee sprains
Topical Diclofenac vs. Oral Ibuprofen for Musculoskeletal Pain in Children: A Multi-centre, Randomized Pilot Feasibility Trial
This trial will try whether diclofenac gel applied to the injured ankle or knee works as well as oral ibuprofen for children aged 6–18 with new sprains or strains.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 2 sites (Calgary, Alberta and 1 other locations) |
| Trial ID | NCT07145645 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 6–18 with a new (≤4 days) non-fractured ankle or knee soft-tissue injury, a pain score ≥3 with movement, and the ability to apply topical treatment and complete follow-up surveys.
Not a fit: Children with fractures, skin conditions or casts that prevent topical application, known contraindications to NSAIDs, or those unable to complete follow-up are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, topical diclofenac could offer similar pain relief with a lower risk of systemic side effects compared with oral ibuprofen for children with ankle or knee sprains.
How similar studies have performed: Adult trials have shown topical NSAIDs perform similarly to oral NSAIDs for musculoskeletal pain, but pediatric evidence is currently lacking, so this approach is partly supported by adult data but novel in children.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Calgary, Alberta and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.