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Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children
Sponsor: University of Calgary
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.
Official title: Topical Diclofenac vs. Oral Ibuprofen for Musculoskeletal Pain in Children: A Multi-centre, Randomized Pilot Feasibility Trial
Key Details
Gender
All
Age Range
6 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-09-02
Completion Date
2028-03-31
Last Updated
2025-08-28
Healthy Volunteers
No
Interventions
Voltaren 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.
Ibuprofen Oral Suspension 100 mg/5mL
Children's Ibuprofen Oral suspension (Motrin) 100mg/5 mL . Dosing is 10 mg/kg to a maximum of 600mg.
ORA-Blend Oral Suspension
Oral Ibuprofen suspension (labelled as ibuprofen) given at 10 mg/kg to a maximum of 600mg each dose.
VersaPro 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.