A Randomized Trial of NSAID Dosing Strategies

NCT05239767 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 2022-13802
• Study Type: interventional
• Target: 407
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Musculoskeletal Pain; Acute Pain

Outcome Measures

Primary Outcomes (1)

• Failure to achieve a minimum clinically important difference

  Failure to improve by at least 1.3 points on a 0-10 pain scale

  Two hours

Secondary Outcomes (3)

• 0-10 pain score

  One and two hours after medication administration

• Ordinal pain scale

  One and two hours after medication administration

• Epigastric pain

  Two hours after medication administration

Study Arms (2)

Ketorolac

ACTIVE COMPARATOR

Ketorolac 20mg orally x 1

Drug: NSAID

Ibuprofen

ACTIVE COMPARATOR

Ibuprofen 800mg orally x 1

Drug: NSAID

Interventions

NSAID DRUG

We will administer oral NSAIDs

Ibuprofen; Ketorolac

Eligibility Criteria

• Age: 18 Years - 69 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Acute Pain

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Benjamin W Friedman, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: NSAID will be masked. Acetaminophen or no acetaminophen will not
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: June 1, 2022
• Primary Completion: April 24, 2023
• Study Completion: April 24, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)