Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children

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.

Conditions

• Musculoskeletal Injury
• Pediatrics
• Sprain and Strain of Ankle
• Sprain Knee
• Strain Knee

Interventions

DRUG

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.

DRUG

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.

DRUG

ORA-Blend Oral Suspension

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

DRUG

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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation

  collaborator OTHER

• University of Calgary

  lead OTHER

Principal Investigators

• Mohamed M Eltorki, MBChB, MSc · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-02

Primary Completion

2027-09-30

Completion

2028-03-31

Countries

• Canada

Study Locations