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

• ClinicalTrials.gov Identifier: NCT01092676
• Recruitment Status: Completed
• First Posted: March 25, 2010
• Results First Posted: November 26, 2019
• Last Update Posted: November 26, 2019
• Sponsor: Lawson Health Research Institute
• Information provided by (Responsible Party): Lawson Health Research Institute

Tracking Information

• First Submitted Date: March 23, 2010
• First Posted Date: March 25, 2010
• Results First Submitted Date: August 22, 2017
• Results First Posted Date: November 26, 2019
• Last Update Posted Date: November 26, 2019
• Study Start Date: February 2010
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 7, 2019)

• Change in Visual Analog Scale (VAS) Pain on Weight Bearing From Baseline [ Time Frame: 4 days ]
  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.
• Change in Visual Analog Scale (VAS) for Disability [ Time Frame: 4 days ]
  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.

Original Primary Outcome Measures (submitted: March 23, 2010)

• Less Pain on Weight Bearing [ Time Frame: 4 days ]
• Less Disability [ Time Frame: 4 days ]

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: March 23, 2010)

• Less Swelling [ Time Frame: 4 Days ]
• Pain on Passive Motion [ Time Frame: 4 Days ]
• Tenderness on examination [ Time Frame: 4 days ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Regular vs Intermittent Dose Ibuprofen for the Treatment of Ankle Sprains in Children
• Official Title: Regular vs Intermittent Dose Ibuprofen for the Treatment of Ankle Sprains in Children

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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Ibuprofen
• Ankle Injuries

Intervention

• Drug: Ibuprofen Regular Dosing
  Regular dosing
• Drug: PRN dosing Ibuprofen
  PRN dosing Ibupofen

Study Arms

• Active Comparator: Regular Ibuprofen Dosing
  Regular Ibuprofen Dosing throughout 4 days of study
  Intervention: Drug: Ibuprofen Regular Dosing
• Active Comparator: PRN Ibuprofen dosing
  As needed Ibuprofen dosing
  Intervention: Drug: PRN dosing Ibuprofen

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 7, 2019): 100
• Original Estimated Enrollment (submitted: March 23, 2010): 90
• Actual Study Completion Date: June 2016
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 7 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01092676
• Other Study ID Numbers: R-08-502; REB 15517 ( Other Identifier: Research Ethics Board Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Lawson Health Research Institute
• Study Sponsor: Lawson Health Research Institute
• Collaborators: Not Provided

Investigators

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

• PRS Account: Lawson Health Research Institute
• Verification Date: November 2019