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

NCT ID: NCT01827475

Last Updated: 2014-12-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-07-31

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.

Conditions

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Pain

Keywords

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musculoskeletal pain acetaminophen ibuprofen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ibuprofen

Ibuprofen 800 mg

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

single dose

Acetaminophen

Acetaminophen 1 gm

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

single dose

Ibuprofen-acetaminophen combination

Ibuprofen 800 mg plus acetaminophen 1 gm

Group Type EXPERIMENTAL

Ibuprofen-acetaminophen combination

Intervention Type DRUG

single dose

Interventions

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Ibuprofen

single dose

Intervention Type DRUG

Acetaminophen

single dose

Intervention Type DRUG

Ibuprofen-acetaminophen combination

single dose

Intervention Type DRUG

Other Intervention Names

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motrin tylenol motrin tylenol

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Adam Singer

Professor and Vice Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam J Singer, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

References

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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.

Reference Type DERIVED
PMID: 32797734 (View on PubMed)

Other Identifiers

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IRBNet119536

Identifier Type: -

Identifier Source: org_study_id