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

December 29, 2014 updated by: Adam Singer, Stony Brook University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ibuprofen
Ibuprofen 800 mg
Drug: Ibuprofen
single dose
Other Names:
  • motrin
Active Comparator: Acetaminophen
Acetaminophen 1 gm
Drug: Acetaminophen
single dose
Other Names:
  • tylenol
Experimental: Ibuprofen-acetaminophen combination
Ibuprofen 800 mg plus acetaminophen 1 gm
Drug: Ibuprofen-acetaminophen combination
single dose
Other Names:
  • tylenol
  • motrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Severity
Time Frame: 1 hour
Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain)
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for Rescue Pain Relief
Time Frame: 1 hour
The need for additional analgesics
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Investigators

  • Principal Investigator: Adam J Singer, MD, Stony Brook University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

April 4, 2013

First Submitted That Met QC Criteria

April 8, 2013

First Posted (Estimate)

April 9, 2013

Study Record Updates

Last Update Posted (Estimate)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBNet119536

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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