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

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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:
Information provided by (Responsible Party):
Lawson Health Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Ibuprofen
Ankle Injuries
Interventions Drug: Ibuprofen Regular Dosing
Drug: PRN dosing Ibuprofen
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Regular Ibuprofen Dosing PRN Ibuprofen Dosing
Hide Arm/Group Description

Regular Ibuprofen Dosing throughout 4 days of study

Ibuprofen Regular Dosing: Regular dosing

As needed Ibuprofen dosing

PRN dosing Ibuprofen: PRN dosing Ibupofen

Period Title: Overall Study
Started 50 49
Completed 50 49
Not Completed 0 0
Arm/Group Title Regular Ibuprofen Dosing PRN Ibuprofen Dosing Total
Hide Arm/Group Description

Regular Ibuprofen Dosing throughout 4 days of study

Ibuprofen Regular Dosing: Regular dosing

As needed Ibuprofen dosing

PRN dosing Ibuprofen: PRN dosing Ibupofen

Total of all reporting groups
Overall Number of Baseline Participants 50 49 99
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 99 participants
<=18 years
50
 100.0%
49
 100.0%
99
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 99 participants
Female
28
  56.0%
29
  59.2%
57
  57.6%
Male
22
  44.0%
20
  40.8%
42
  42.4%
1.Primary Outcome
Title Change in Visual Analog Scale (VAS) Pain on Weight Bearing From Baseline
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regular Ibuprofen Dosing PRN Ibuprofen Dosing
Hide Arm/Group Description:

Regular Ibuprofen Dosing throughout 4 days of study

Ibuprofen Regular Dosing: Regular dosing

As needed Ibuprofen dosing

PRN dosing Ibuprofen: PRN dosing Ibupofen

Overall Number of Participants Analyzed 50 49
Mean (Standard Deviation)
Unit of Measure: mm
6.96  (2.26) 6.70  (2.17)
2.Primary Outcome
Title Change in Visual Analog Scale (VAS) for Disability
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regular Ibuprofen Dosing PRN Ibuprofen Dosing
Hide Arm/Group Description:

Regular Ibuprofen Dosing throughout 4 days of study

Ibuprofen Regular Dosing: Regular dosing

As needed Ibuprofen dosing

PRN dosing Ibuprofen: PRN dosing Ibupofen

Overall Number of Participants Analyzed 50 49
Mean (Standard Deviation)
Unit of Measure: mm
6.44  (2.83) 6.14  (2.35)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Regular Ibuprofen Dosing PRN Ibuprofen Dosing
Hide Arm/Group Description

Regular Ibuprofen Dosing throughout 4 days of study

Ibuprofen Regular Dosing: Regular dosing

As needed Ibuprofen dosing

PRN dosing Ibuprofen: PRN dosing Ibupofen

All-Cause Mortality
Regular Ibuprofen Dosing PRN Ibuprofen Dosing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)      0/49 (0.00%)    
Hide Serious Adverse Events
Regular Ibuprofen Dosing PRN Ibuprofen Dosing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/49 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Regular Ibuprofen Dosing PRN Ibuprofen Dosing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/50 (4.00%)      2/49 (4.08%)    
Gastrointestinal disorders     
nausea and abdominal pain *  2/50 (4.00%)  6 2/49 (4.08%)  5
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rodrick Lim
Organization: LHSC Lawson HRI
Phone: 5198525496
EMail: rod.lim@lhsc.on.ca
Layout table for additonal information
Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01092676    
Other Study ID Numbers: R-08-502
REB 15517 ( Other Identifier: Research Ethics Board Number )
First Submitted: March 23, 2010
First Posted: March 25, 2010
Results First Submitted: August 22, 2017
Results First Posted: November 26, 2019
Last Update Posted: November 26, 2019