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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Acetaminophen
* Drug: Ibuprofen-acetaminophen combination


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ibuprofen<br>Ibuprofen 800 mg | Drug: Ibuprofen<br>* single dose<br>* Other names: motrin;|
| Active Comparator: Acetaminophen<br>Acetaminophen 1 gm | Drug: Acetaminophen<br>* single dose<br>* Other names: tylenol;|
| Experimental: Ibuprofen-acetaminophen combination<br>Ibuprofen 800 mg plus acetaminophen 1 gm | Drug: Ibuprofen-acetaminophen combination<br>* single dose<br>* Other names: tylenol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Severity | 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 | The need for additional analgesics | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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musculoskeletal pain, acetaminophen, ibuprofen