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Trial record 83 of 814 for:    IBUPROFEN

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

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ClinicalTrials.gov Identifier: NCT01827475
Recruitment Status : Completed
First Posted : April 9, 2013
Results First Posted : December 31, 2014
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Adam Singer, 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.

Condition or disease Intervention/treatment Phase
Pain Drug: Ibuprofen Drug: Acetaminophen Drug: Ibuprofen-acetaminophen combination Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting
Study Start Date : July 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ibuprofen
Ibuprofen 800 mg
Drug: Ibuprofen
single dose
Other Name: motrin

Active Comparator: Acetaminophen
Acetaminophen 1 gm
Drug: Acetaminophen
single dose
Other Name: tylenol

Experimental: Ibuprofen-acetaminophen combination
Ibuprofen 800 mg plus acetaminophen 1 gm
Drug: Ibuprofen-acetaminophen combination
single dose
Other Names:
  • motrin
  • tylenol




Primary Outcome Measures :
  1. Pain Severity [ Time Frame: 1 hour ]
    Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain)


Secondary Outcome Measures :
  1. Need for Rescue Pain Relief [ Time Frame: 1 hour ]
    The need for additional analgesics



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827475


Sponsors and Collaborators
Stony Brook University
Investigators
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Principal Investigator: Adam J Singer, MD Stony Brook University

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Responsible Party: Adam Singer, Professor and Vice Chair, Stony Brook University
ClinicalTrials.gov Identifier: NCT01827475     History of Changes
Other Study ID Numbers: IRBNet119536
First Posted: April 9, 2013    Key Record Dates
Results First Posted: December 31, 2014
Last Update Posted: December 31, 2014
Last Verified: December 2014
Keywords provided by Adam Singer, Stony Brook University:
musculoskeletal pain
acetaminophen
ibuprofen
Additional relevant MeSH terms:
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Ibuprofen
Musculoskeletal Pain
Emergencies
Disease Attributes
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action