Trial Outcomes & Findings for Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting (NCT NCT01827475)

NCT ID: NCT01827475

Last Updated: 2014-12-31

Results Overview

Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 90 participants
• Primary outcome timeframe: 1 hour
• Results posted on: 2014-12-31

Participant Flow

Patients were recruited from the emergency department over a 1 year period

Participant milestones

Measure	Ibuprofen Ibuprofen 800 mg	Acetaminophen Acetaminophen 1 gm	Ibuprofen-acetaminophen Combination Ibuprofen 800 mg plus acetaminophen 1 gm
Overall Study STARTED	30	30	30
Overall Study COMPLETED	30	30	30
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting

Baseline characteristics by cohort

Measure	Ibuprofen n=30 Participants Ibuprofen 800 mg	Acetaminophen n=30 Participants Acetaminophen 1 gm	Ibuprofen-acetaminophen Combination n=30 Participants Ibuprofen 800 mg plus acetaminophen 1 gm	Total n=90 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	30 Participants n=7 Participants	28 Participants n=5 Participants	86 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Age, Continuous	31 years STANDARD_DEVIATION 16 • n=5 Participants	34 years STANDARD_DEVIATION 12 • n=7 Participants	37 years STANDARD_DEVIATION 17 • n=5 Participants	36 years STANDARD_DEVIATION 15 • n=4 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants	41 Participants n=4 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	18 Participants n=7 Participants	15 Participants n=5 Participants	49 Participants n=4 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	30 participants n=5 Participants	90 participants n=4 Participants

PRIMARY outcome

Timeframe: 1 hour

Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain)

Outcome measures

Measure	Ibuprofen n=30 Participants Ibuprofen 800 mg	Acetaminophen n=30 Participants Acetaminophen 1 gm	Ibuprofen-acetaminophen Combination n=30 Participants Ibuprofen 800 mg plus acetaminophen 1 gm
Pain Severity	39 mm Interval 28.0 to 50.0	43 mm Interval 33.0 to 53.0	42 mm Interval 32.0 to 51.0

SECONDARY outcome

Timeframe: 1 hour

The need for additional analgesics

Outcome measures

Measure	Ibuprofen n=30 Participants Ibuprofen 800 mg	Acetaminophen n=30 Participants Acetaminophen 1 gm	Ibuprofen-acetaminophen Combination n=30 Participants Ibuprofen 800 mg plus acetaminophen 1 gm
Need for Rescue Pain Relief	11 participants	10 participants	5 participants

Adverse Events

Ibuprofen

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ibuprofen-acetaminophen Combination

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ibuprofen n=30 participants at risk Ibuprofen 800 mg	Acetaminophen n=30 participants at risk Acetaminophen 1 gm	Ibuprofen-acetaminophen Combination n=30 participants at risk Ibuprofen 800 mg plus acetaminophen 1 gm
Gastrointestinal disorders abdominal pain	0.00% 0/30 • 7 days	0.00% 0/30 • 7 days	3.3% 1/30 • 7 days
Gastrointestinal disorders Nausea	3.3% 1/30 • 7 days	0.00% 0/30 • 7 days	0.00% 0/30 • 7 days

Additional Information

Dr. Adam Singer

Emergency Medicine, Stony Brook U

Phone: 631 444 7856

Email: adam.singer@stonybrook.edu

Results disclosure agreements

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