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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01092676
Recruitment Status : Unknown
Verified June 2010 by Lawson Health Research Institute.
Recruitment status was:  Recruiting
First Posted : March 25, 2010
Last Update Posted : June 4, 2010
Information provided by:
Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Ibuprofen Ankle Injuries Drug: Ibuprofen Regular Dosing Drug: PRN dosing Ibuprofen Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Regular vs Intermittent Dose Ibuprofen for the Treatment of Ankle Sprains in Children
Study Start Date : February 2010
Estimated Primary Completion Date : February 2012

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Less Pain on Weight Bearing [ Time Frame: 4 days ]
    Pain Scale 0-10 Visual Analog Scale

  2. Less Disability [ Time Frame: 4 days ]
    0-10 Visual Analog Scale

Secondary Outcome Measures :
  1. Less Swelling [ Time Frame: 4 Days ]
  2. Pain on Passive Motion [ Time Frame: 4 Days ]
  3. Tenderness on examination [ Time Frame: 4 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01092676

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Contact: Rodrick Lim, MD FRCPC 519 6858500 ext 58134
Contact: Gurinder Sangha 519 6858500

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Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Rodrick Lim    519 6858500   
Contact: Gurinder Sangha    519 6858500   
Principal Investigator: Rodrick Lim, MD         
Sub-Investigator: Gurinder Sangha         
Sub-Investigator: Michael Rieder         
Sponsors and Collaborators
Lawson Health Research Institute
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Principal Investigator: Rodrick Lim, MD,FRCPC,FAAP Lawson Health Research Institute

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Responsible Party: Rodrick Lim, Children's Health Research Institute: LHRI Identifier: NCT01092676     History of Changes
Other Study ID Numbers: R-08-502
REB 15517 ( Other Identifier: Research Ethics Board Number )
First Posted: March 25, 2010    Key Record Dates
Last Update Posted: June 4, 2010
Last Verified: June 2010
Keywords provided by Lawson Health Research Institute:
Additional relevant MeSH terms:
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Ankle Injuries
Wounds and Injuries
Leg Injuries
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action