Trial Outcomes & Findings for Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever (NCT NCT00267293)

NCT ID: NCT00267293

Last Updated: 2012-05-09

Results Overview

Temperature was measured hourly using a temporal thermometer to monitor the child's temperature in degrees C. Temperature of 38 degrees C or higher was considered febrile.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: 6 hours
• Results posted on: 2012-05-09

Participant Flow

Participant milestones

Measure	Group A: Ibuprofen Alone Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.	Group B: Ibuprofen and Acetaminophen time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.	Group C: Ibuprofen Then Acetaminophen Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
Overall Study STARTED	20	20	20
Overall Study COMPLETED	20	20	20
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever

Baseline characteristics by cohort

Measure	Group A: Ibuprofen Alone n=20 Participants Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.	Group B: Ibuprofen and Acetaminophen n=20 Participants time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.	Group C: Ibuprofen Then Acetaminophen n=20 Participants Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	60 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	3.2 years STANDARD_DEVIATION 1.9 • n=5 Participants	3.0 years STANDARD_DEVIATION 1.9 • n=7 Participants	4.0 years STANDARD_DEVIATION 2.8 • n=5 Participants	3.4 years STANDARD_DEVIATION 2.2 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	31 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	29 Participants n=4 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	20 participants n=5 Participants	60 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 hours

Population: Analysis was ITT per sample size calculation at 80% power.

Temperature was measured hourly using a temporal thermometer to monitor the child's temperature in degrees C. Temperature of 38 degrees C or higher was considered febrile.

Outcome measures

Measure	Group A: Ibuprofen Alone n=20 Participants Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.	Group B: Ibuprofen and Acetaminophen n=20 Participants time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.	Group C: Ibuprofen Then Acetaminophen n=20 Participants Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
Child Temperature (Degrees C)Over 6 Hours	38.5 degrees Celcius Standard Deviation 1.5	37.2 degrees Celcius Standard Deviation 0.6	36.9 degrees Celcius Standard Deviation 0.3

Adverse Events

Group A: Ibuprofen Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B: Ibuprofen and Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group C: Ibuprofen Then Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ian M Paul, MD, MSc

Penn State Children's Hospital

Phone: 717-531-5656

Email: ipaul@hmc.psu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place