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

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.

Study Overview

• Status: Completed
• Conditions: Ankle Injuries; Ibuprofen
• Intervention / Treatment: Drug: Ibuprofen Regular Dosing; Drug: PRN dosing Ibuprofen

Detailed Description

Acute ankle sprains are one of the most common musculoskeletal injuries in children and adolescents seeking medical attention. There are an estimated 2 million ankle injuries a year and they represent 20 percent of all sports injuries. Data from the National Hospital Ambulatory Medical Care Survey in 2000 showed approximately 1.375 million visits to emergency departments (ED) in the US due to ankle sprains. This represented about 1.3% of all ED visits. The majority of these injuries occur in young athletes. One epidemiological study showed the prevalence of ankle sprains to be 73% in athletes.

The majority of ankle injuries do not involve bony fractures, rather they involve the soft tissue structures of the ankle joint. An ankle sprain is a stretching, partial or complete tear of the ligaments of the ankle. The most common type of ankle sprain is a lateral sprain, usually caused by an inversion injury. Ankle sprains can be classified as a grade I to III, depending on the severity of the injury. A grade I injury is a slight stretching of the ligament; whereas, a grade III sprain is a complete tear of the ligament.

Treatment of ankle sprains is aimed at decreasing the pain and swelling and protecting the ankle ligaments from further injury. The most commonly used acute management strategy includes the RICE (Rest, Ice, Compression, Elevation) protocol. The pharmacologic treatment of ankle sprains however, remains somewhat unclear. Analgesia with acetaminophen was historically the treatment of choice. However, with the development of over the counter NSAID (non-steroidal anti-inflammatory drug) agents, these have become increasingly popular for the treatment of ankle sprains. NSAIDS are a heterogeneous group of drugs that have analgesic, anti-pyretic, and anti-inflammatory effects. They have been used extensively in both adults and children, with ibuprofen being the most commonly used NSAID in North America. The theoretical advantage of the anti-inflammatory action, in addition to the excellent safety profile in children, has made ibuprofen the treatment of choice for musculoskeletal pain in this population.

Controlled trials in adults of various NSAIDS in ankle sprains have shown mixed results. Although they have shown a beneficial effect compared to placebo, they have not consistently shown a benefit over other analgesic choices. Nonetheless, The American Academy of Orthopedic Surgeons recommends that NSAIDs be used to control pain and inflammation in the treatment of acute ankle sprains.

There is very little evidence for the pharmacologic treatment of ankle sprains in children. A study completed at our centre involving 80 patients with acute ankle sprains showed no beneficial effect of naproxyn over acetaminophen in the treatment of pain. However, a study from Ottawa looking at pain relief in all types of musculoskeletal injury, showed a benefit of ibuprofen over both acetaminophen and codeine for pain control. Despite the scant evidence of the benefit of NSAIDS in pediatric ankle sprains, the American Academy of Pediatrics suggests that NSAIDS "can help reduce swelling and pain" in the treatment of ankle sprains.

There currently are no guidelines recommending a dosing schedule of ibuprofen for acute ankle sprains in children. Whether regularly dosed ibuprofen is beneficial versus as-needed dosing of NSAIDs, remains unclear. Interestingly, an unpublished informal survey of the pediatric emergency physicians at the Children's Hospital of Western Ontario, revealed universal recommendations of RICE therapy and the use of ibuprofen for the treatment of ankle sprains. However, the recommendations for ibuprofen dosing varied widely from as-needed to regular dosing.

The purpose of this study is to examine if regular dosed ibuprofen has an advantage over as-needed dosed ibuprofen in the treatment of acute ankle sprains in children.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Regular Ibuprofen Dosing; Regular Ibuprofen Dosing throughout 4 days of study	Drug: Ibuprofen Regular Dosing; Regular dosing
Active Comparator: PRN Ibuprofen dosing; As needed Ibuprofen dosing	Drug: PRN dosing Ibuprofen; PRN dosing Ibupofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Rodrick Lim, MD,FRCPC,FAAP, Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 23, 2010
• First Submitted That Met QC Criteria: March 23, 2010
• First Posted (Estimate): March 25, 2010

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 7, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Pediatrics; Emergency
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: R-08-502; REB 15517 (Other Identifier: Research Ethics Board Number)