Could a simple gel replace pills for Kids' pain?
NCT ID NCT07145645
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests whether a topical diclofenac gel (Voltaren) works as well as oral ibuprofen for reducing pain in children aged 6-18 with ankle or knee sprains. Sixty participants will use either the gel or oral medicine three times a day for three days, then report their pain levels over two weeks. The main goal is to see if a larger trial is possible, not to prove which treatment is better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- diclofenac gel (Voltaren) and ibuprofen oral suspension (Children's Motrin)
- What this could lead to
- If successful, this could show that a topical gel is a safe and effective alternative to oral pain medicine for children with sprains and strains, potentially reducing side effects like stomach upset.
- What could go wrong
- This is a small pilot study with only 60 participants, focused on feasibility rather than proving effectiveness. The results may not apply to all children or injuries, and the gel may not work as well as expected.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Alberta Children's Hospital
RECRUITINGCalgary, Alberta, T3B 6A8, Canada
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Stollery Children's Hospital
NOT_YET_RECRUITINGEdmonton, Alberta, T6G 2B7, Canada
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