Trial Outcomes & Findings for Regular vs Intermittent Dose Ibuprofen for the Treatment of Ankle Sprains in Children (NCT NCT01092676)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

4 days

Results posted on

2019-11-26

Participant Flow

Participant milestones

Participant milestones
Measure	Regular Ibuprofen Dosing Regular Ibuprofen Dosing throughout 4 days of study Ibuprofen Regular Dosing: Regular dosing	PRN Ibuprofen Dosing As needed Ibuprofen dosing PRN dosing Ibuprofen: PRN dosing Ibupofen
Overall Study STARTED	50	49
Overall Study COMPLETED	50	49
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regular Ibuprofen Dosing n=50 Participants Regular Ibuprofen Dosing throughout 4 days of study Ibuprofen Regular Dosing: Regular dosing	PRN Ibuprofen Dosing n=49 Participants As needed Ibuprofen dosing PRN dosing Ibuprofen: PRN dosing Ibupofen	Total n=99 Participants Total of all reporting groups
Age, Categorical <=18 years	50 Participants n=5 Participants	49 Participants n=7 Participants	99 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Regular Ibuprofen Dosing n=50 Participants Regular Ibuprofen Dosing throughout 4 days of study Ibuprofen Regular Dosing: Regular dosing	PRN Ibuprofen Dosing n=49 Participants As needed Ibuprofen dosing PRN dosing Ibuprofen: PRN dosing Ibupofen
Change in Visual Analog Scale (VAS) Pain on Weight Bearing From Baseline	6.96 mm Standard Deviation 2.26	6.70 mm Standard Deviation 2.17

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Regular Ibuprofen Dosing n=50 Participants Regular Ibuprofen Dosing throughout 4 days of study Ibuprofen Regular Dosing: Regular dosing	PRN Ibuprofen Dosing n=49 Participants As needed Ibuprofen dosing PRN dosing Ibuprofen: PRN dosing Ibupofen
Change in Visual Analog Scale (VAS) for Disability	6.44 mm Standard Deviation 2.83	6.14 mm Standard Deviation 2.35

Adverse Events

Regular Ibuprofen Dosing

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

PRN Ibuprofen Dosing

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Regular Ibuprofen Dosing n=50 participants at risk Regular Ibuprofen Dosing throughout 4 days of study Ibuprofen Regular Dosing: Regular dosing	PRN Ibuprofen Dosing n=49 participants at risk As needed Ibuprofen dosing PRN dosing Ibuprofen: PRN dosing Ibupofen
Gastrointestinal disorders nausea and abdominal pain	4.0% 2/50 • Number of events 6	4.1% 2/49 • Number of events 5

Additional Information

Rodrick Lim

LHSC Lawson HRI

Phone: 5198525496

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place