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

NCT01092676 | Completed Results

• 2 other identifiers: R-08-502REB 15517
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ibuprofen; Ankle Injuries

Keywords

Pediatrics; Emergency

Outcome Measures

Primary Outcomes (2)

• Change in Visual Analog Scale (VAS) Pain on Weight Bearing From Baseline

  Change in Pain Scale 0-10 Visual Analog Scale with 0 being no pain and 10 being unbearable pain. Outcome is measured in mm as measured from 0 to where the participant places indicated their pain to be on the scale.

  4 days

• Change in Visual Analog Scale (VAS) for Disability

  0-10 Visual Analog Scale with 0 being no disability and 10 being severe disability. Patients are asked to place a line on the VAS to where they believe their disability to be. The final outcome is then measured in mm from 0 to the line placed by the patient.

  4 days

Study Arms (2)

Regular Ibuprofen Dosing

ACTIVE COMPARATOR

Regular Ibuprofen Dosing throughout 4 days of study

Drug: Ibuprofen Regular Dosing

PRN Ibuprofen dosing

ACTIVE COMPARATOR

As needed Ibuprofen dosing

Drug: PRN dosing Ibuprofen

Interventions

Ibuprofen Regular Dosing DRUG

Regular dosing

Regular Ibuprofen Dosing

PRN dosing Ibuprofen DRUG

PRN dosing Ibupofen

PRN Ibuprofen dosing

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Ankle Injuries; Emergencies

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Rodrick Lim
• Organization: LHSC Lawson HRI

rod.lim@lhsc.on.ca

5198525496

Study Officials

• Rodrick Lim, MD,FRCPC,FAAP

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 25, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 26, 2019
• Results First Posted: November 26, 2019

Record last verified: 2019-11

Locations

CA (1)