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Clinical Trials/NCT01827475
NCT01827475
Completed
Phase 2

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

Stony Brook University0 sites90 target enrollmentJuly 2010

Overview

Phase
Phase 2
Intervention
Ibuprofen
Conditions
Pain
Sponsor
Stony Brook University
Enrollment
90
Primary Endpoint
Pain Severity
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
July 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Adam Singer

Professor and Vice Chair

Stony Brook University

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.

Arms & Interventions

Ibuprofen

Ibuprofen 800 mg

Intervention: Ibuprofen

Acetaminophen

Acetaminophen 1 gm

Intervention: Acetaminophen

Ibuprofen-acetaminophen combination

Ibuprofen 800 mg plus acetaminophen 1 gm

Intervention: Ibuprofen-acetaminophen combination

Outcomes

Primary Outcomes

Pain Severity

Time Frame: 1 hour

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

Secondary Outcomes

  • Need for Rescue Pain Relief(1 hour)

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