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

• 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: Stony Brook University
• Information provided by (Responsible Party): Adam Singer, Stony Brook University

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Sponsors and Collaborators

Stony Brook University

Investigators

• Principal Investigator: Adam J Singer, MD; Stony Brook University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:CD007789. doi: 10.1002/14651858.CD007789.pub3.

• Responsible Party: Adam Singer, Professor and Vice Chair, Stony Brook University
• ClinicalTrials.gov Identifier: NCT01827475
• Other Study ID Numbers: IRBNet119536
• First Posted: April 9, 2013
• 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:

Musculoskeletal Pain; Emergencies; Disease Attributes; Pathologic Processes; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Acetaminophen; Ibuprofen; 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