Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 2, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

March 31, 2028

Conditions
Musculoskeletal InjuryPediatricsSprain and Strain of AnkleSprain KneeStrain 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."

All Listed Sponsors
lead

University of Calgary

OTHER

collaborator

Hamilton Health Sciences Corporation

OTHER