N/A N=99 Randomized Double-blind Treatment

Regular vs Intermittent Dose Ibuprofen for the Treatment of Ankle Sprains in Children

Ibuprofen · Ankle Injuries

Bottom Line

View on ClinicalTrials.gov: NCT01092676 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: Change in Visual Analog Scale (VAS) Pain on Weight Bearing From Baseline — 6.96; 6.70 mm

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ibuprofen Regular Dosing (Drug); PRN dosing Ibuprofen (Drug)
Age: Pediatric · 7+ yrs
Sex: All
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Visual Analog Scale (VAS) Pain on Weight Bearing From Baseline	6.96; 6.70	—
PRIMARY Change in Visual Analog Scale (VAS) for Disability	6.44; 6.14	—

Summary

Ankle sprains are common in children, and optimal pain management has not been determined. We hypothesize that children age 7-17 years of age with acute ankle sprain randomized to receive regular dose ibuprofen will show a greater improvement in degree of pain,disability,swelling and tenderness four days following injury as compared to children who take ibuprofen only intermittently for pain relief during the same time period.

Eligibility Criteria

Inclusion Criteria

Ages 7-17 years who have suffered an isolated ankle sprain within the last 24 hours
Able to return for follow-up with research assistant in 4 days time

Exclusion Criteria

Preexisting Metabolic bone disease
Bilateral ankle sprains
Fractured ankle as demonstrated on X-ray
Suspected Salter 1 fracture or syndesmosis injury
Other traumatic injuries
History of Gastric ulcers or renal disease
Known or suspected allergy/sensitivity to ibuprofen
Previous ankle sprain of affected ankle within last 6 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01092676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.