N/A Completed N=99 Randomized Double-blind Treatment

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

Ibuprofen · Ankle Injuries

Source: ClinicalTrials.gov NCT01092676 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

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

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.

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	—

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. Informational only — not medical advice.