Regular vs Intermittent Dose Ibuprofen for the Treatment of Ankle Sprains in Children
Condition: Ibuprofen; Ankle Injuries
MeSH terms: Ankle Injuries
Study type: Interventional

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.
    

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.
    

Intervention name(s): Ibuprofen Regular Dosing; PRN dosing Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): Regular dosing; PRN dosing Ibupofen
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatrics; Emergency