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

Phase 2

Completed

• Conditions: Pain
• Interventions: Drug: Ibuprofen-acetaminophen combination; Drug: Acetaminophen; Drug: Ibuprofen

• Registration Number: NCT01827475
• Lead Sponsor: Stony Brook University

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.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-08
• Study First Posted: 2013-04-09
• Results First Submitted: 2013-04-09
• Status Verified: 2014-12
• Results First Submitted QC: 2014-12-29
• Last Update Submitted: 2014-12-29
• Results First Posted: 2014-12-31
• Last Update Posted: 2014-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen-acetaminophen combination	Ibuprofen-acetaminophen combination	Ibuprofen 800 mg plus acetaminophen 1 gm
Acetaminophen	Acetaminophen	Acetaminophen 1 gm
Ibuprofen	Ibuprofen	Ibuprofen 800 mg

Primary Outcome Measures

Name	Time	Method
Pain Severity	1 hour	Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain)

Secondary Outcome Measures

Name	Time	Method
Need for Rescue Pain Relief	1 hour	The need for additional analgesics