RecruitingPhase 3NCT07145645

Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children

Topical Diclofenac vs. Oral Ibuprofen for Musculoskeletal Pain in Children: A Multi-centre, Randomized Pilot Feasibility Trial


Sponsor

University of Calgary

Enrollment

60 participants

Start Date

Apr 2, 2026

Study Type

INTERVENTIONAL

Conditions

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 (Peds ED) comparing Non-Steroidal Anti-Inflammatory (NSAID) gel applied to a new ankle or knee injury to NSAIDs taken by mouth in kids aged 6-18. The investigators want to determine if the gel works as well or better at reducing pain than NSAIDs given by mouth. Based on studies done on adults, the investigators know that NSAIDs that are applied directly to an injury work as well at relieving pain as NSAIDs that are taken by mouth. Another goal of this pilot trial is to determine if it is possible to recruit participants to the study, and if the participants complete the questionnaire and take the medications as prescribed on Day 1. The participants will be in the study for 14 days. Participants will be required to take the oral NSAID medication and to apply the topical NSAID gel 3 times a day for the first 3 days after their visit to the ED. The investigators will ask the participants to rate their pain on a scale of 0 (no pain) to 10 (worst pain ever) before and after they use the medicine. On day 7, the participants will rate their pain, and their activity level. On day 14 participants will do the same.


Eligibility

Min Age: 6 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ibuprofen Oral Suspension 100 mg/5mL, a drug called ORA-Blend Oral Suspension, and others for people with musculoskeletal injury, pediatrics, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVoltaren Topical Gel

Topical diclofenac emulgel (Voltaren) 11.6 mg/g. Dosing is based on weight bands: 25 kg: 2 grams/dose, ≥25 kg - \<40 kg: 3 grams/dose; and \>40 kg: 4 grams/dose. ATC code: M02A A15.

DRUGIbuprofen Oral Suspension 100 mg/5mL

Children's Ibuprofen Oral suspension (Motrin) 100mg/5 mL . Dosing is 10 mg/kg to a maximum of 600mg.

DRUGORA-Blend Oral Suspension

Oral Ibuprofen suspension (labelled as ibuprofen) given at 10 mg/kg to a maximum of 600mg each dose.

DRUGVersaPro Cream Base for Compounding

Topical Versapro Cream emulgel (labeled as diclofenac diethylamine). Dose is based on the following weight bands: 25 kg: 2 grams/dose; ≥25 kg - \<40 kg: 3 grams/dose; and \>40 kg: 4 grams/dose.


Locations(2)

Alberta Children's Hospital

Calgary, Alberta, Canada

Stollery Children's Hospital

Edmonton, Alberta, Canada

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NCT07145645


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