A Randomized Trial of NSAID Dosing Strategies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-04-24

Brief Summary

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This study will compare the efficacy of two different non-steroidal anti-inflammatory drugs (NSAIDs) ketorolac and ibuprofen for people with acute moderate or severe musculoskeletal pain. The investigators will also determine whether taking acetaminophen prior to the NSAID impacts efficacy

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Detailed Description

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Conditions

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Musculoskeletal Pain Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

NSAID will be masked. Acetaminophen or no acetaminophen will not

Study Groups

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Ketorolac

Ketorolac 20mg orally x 1

Group Type ACTIVE_COMPARATOR

NSAID

Intervention Type DRUG

We will administer oral NSAIDs

Ibuprofen

Ibuprofen 800mg orally x 1

Group Type ACTIVE_COMPARATOR

NSAID

Intervention Type DRUG

We will administer oral NSAIDs

Interventions

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NSAID

We will administer oral NSAIDs

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months
* Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity

Exclusion Criteria

* Contraindication to NSAIDs (allergy to NSAID or allergy to aspirin without history of tolerating NSAIDs, history of gastrointestinal bleeding, daily medication for gastritis or PUD, chronic kidney disease 2-5, heart failure)
* Contraindication to acetaminophen (hepatitis or cirrhosis)
* Use of an NSAID within the previous eight hours
* Use of acetaminophen within the previous eight hours
* Chronic pain, defined as any pain on \>50% of days for at least 3 months prior to onset of acute pain
* Recurrent pain in the same body part as the presenting complaint

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No