Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether the combination of ibuprofen and acetaminophen, is more effective than either single agent alone in treating pain from acute musculoskeletal injuries in the emergency department.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 pain
Started Jul 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 4, 2013
CompletedFirst Posted
Study publicly available on registry
April 9, 2013
CompletedResults Posted
Study results publicly available
December 31, 2014
CompletedDecember 31, 2014
December 1, 2014
1 year
April 4, 2013
April 9, 2013
December 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Severity
Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain)
1 hour
Secondary Outcomes (1)
Need for Rescue Pain Relief
1 hour
Study Arms (3)
Ibuprofen
ACTIVE COMPARATORIbuprofen 800 mg
Acetaminophen
ACTIVE COMPARATORAcetaminophen 1 gm
Ibuprofen-acetaminophen combination
EXPERIMENTALIbuprofen 800 mg plus acetaminophen 1 gm
Interventions
single dose
Eligibility Criteria
You may qualify if:
- Adult patients who presented to the emergency department with pain (a verbal numeric pain score greater than 0 on a scale of 0 to 10 from none to greatest) secondary to an acute musculoskeletal injury of less than 24 hours of duration when one of the study investigators was present were eligible for enrollment
You may not qualify if:
- Patients who had taken an opioid containing analgesic as well as those with a prior history of allergy or contraindications to ibuprofen or acetaminophen.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3.
PMID: 32797734DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Small sample size, single center, short follow up
Results Point of Contact
- Title
- Dr. Adam Singer
- Organization
- Emergency Medicine, Stony Brook U
Study Officials
- PRINCIPAL INVESTIGATOR
Adam J Singer, MD
Stony Brook University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Vice Chair
Study Record Dates
First Submitted
April 4, 2013
First Posted
April 9, 2013
Study Start
July 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
December 31, 2014
Results First Posted
December 31, 2014
Record last verified: 2014-12