Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting
Primary Purpose
Pain
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ibuprofen
Acetaminophen
Ibuprofen-acetaminophen combination
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring musculoskeletal pain, acetaminophen, ibuprofen
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients who had taken an opioid containing analgesic as well as those with a prior history of allergy or contraindications to ibuprofen or acetaminophen.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Ibuprofen
Acetaminophen
Ibuprofen-acetaminophen combination
Arm Description
Ibuprofen 800 mg
Acetaminophen 1 gm
Ibuprofen 800 mg plus acetaminophen 1 gm
Outcomes
Primary Outcome Measures
Pain Severity
Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain)
Secondary Outcome Measures
Need for Rescue Pain Relief
The need for additional analgesics
Full Information
NCT ID
NCT01827475
First Posted
April 4, 2013
Last Updated
December 29, 2014
Sponsor
Stony Brook University
1. Study Identification
Unique Protocol Identification Number
NCT01827475
Brief Title
Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting
Official Title
Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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. We hypothesize that the combination will be more effective than either agent alone in patients presenting to the emergency department with acute pain from musculoskeletal injuries such as sprain, and bruises. While each agent alone is effective to some degree, many patients do not find complete relief with them and often narcotic agents (with all of their potential side effects) are added. In this study patients experiencing any pain will be randomly given either ibuprofen OR acetaminophen OR their combination and their degree of pain severity will be measured every 15 minutes up to one hour. At the end of this 1 hour patients still experiencing pain and requiring additional pain relief will receive additional analgesics at the discretion of their treating physician. We will not only measure how much the pain severity was reduced but also the percentage of patients that require some form of additional or "rescue" medication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
musculoskeletal pain, acetaminophen, ibuprofen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
Ibuprofen 800 mg
Arm Title
Acetaminophen
Arm Type
Active Comparator
Arm Description
Acetaminophen 1 gm
Arm Title
Ibuprofen-acetaminophen combination
Arm Type
Experimental
Arm Description
Ibuprofen 800 mg plus acetaminophen 1 gm
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
motrin
Intervention Description
single dose
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
tylenol
Intervention Description
single dose
Intervention Type
Drug
Intervention Name(s)
Ibuprofen-acetaminophen combination
Other Intervention Name(s)
motrin, tylenol
Intervention Description
single dose
Primary Outcome Measure Information:
Title
Pain Severity
Description
Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain)
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Need for Rescue Pain Relief
Description
The need for additional analgesics
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patients who had taken an opioid containing analgesic as well as those with a prior history of allergy or contraindications to ibuprofen or acetaminophen.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam J Singer, MD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
32797734
Citation
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.
Results Reference
derived
Learn more about this trial
Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting
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