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

Primary Purpose

Ibuprofen, Ankle Injuries

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ibuprofen Regular Dosing
PRN dosing Ibuprofen
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ibuprofen focused on measuring Pediatrics, Emergency

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Regular Ibuprofen Dosing

PRN Ibuprofen dosing

Arm Description

Regular Ibuprofen Dosing throughout 4 days of study

As needed Ibuprofen dosing

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 23, 2010
Last Updated
November 7, 2019
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01092676
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ibuprofen, Ankle Injuries
Keywords
Pediatrics, Emergency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regular Ibuprofen Dosing
Arm Type
Active Comparator
Arm Description
Regular Ibuprofen Dosing throughout 4 days of study
Arm Title
PRN Ibuprofen dosing
Arm Type
Active Comparator
Arm Description
As needed Ibuprofen dosing
Intervention Type
Drug
Intervention Name(s)
Ibuprofen Regular Dosing
Intervention Description
Regular dosing
Intervention Type
Drug
Intervention Name(s)
PRN dosing Ibuprofen
Intervention Description
PRN dosing Ibupofen
Primary Outcome Measure Information:
Title
Change in Visual Analog Scale (VAS) Pain on Weight Bearing From Baseline
Description
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.
Time Frame
4 days
Title
Change in Visual Analog Scale (VAS) for Disability
Description
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.
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrick Lim, MD,FRCPC,FAAP
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada

12. IPD Sharing Statement

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

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