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

Stony Brook University

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: Acetaminophen; Drug: Ibuprofen; Drug: Ibuprofen-acetaminophen combination

Study type: Interventional

Funder types: Other

Identifiers

NCT01827475

IRBNet119536

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups

Ibuprofen

Active Comparator group

Description:

Ibuprofen 800 mg

Treatment:

Drug: Ibuprofen

Acetaminophen

Active Comparator group

Description:

Acetaminophen 1 gm

Treatment:

Drug: Acetaminophen

Ibuprofen-acetaminophen combination

Experimental group

Description:

Ibuprofen 800 mg plus acetaminophen 1 gm

Treatment:

Drug: Ibuprofen-acetaminophen combination