Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture

NCT03749616 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 2009129
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, are excellent medications for providing pain control in certain patients. There is some data to suggest that NSAIDs can be used to reduce postoperative pain and narcotic use in patients who had undergone carpal tunnel release. There are mixed results about the effect of bone healing in adult patients with broken bones. The investigators hypothesize that NSAID administration in the acute phase of distal radius fracture healing will be non-inferior for pain control and decrease the use of opioid analgesics compared to patients who take acetaminophen for pain control during this same time period. Furthermore, the investigators hypothesize that patients will have similar or better patient reported outcomes, range of motion, and strength with the administration of NSAIDs.

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (3)

• Number of Oxycodone Tablets Used for Breakthrough Pain.

  The number and dosing of oxycodone tablets taken per participant for breakthrough pain will be recorded.

  2 weeks

• Intensity of Pain: Visual Analog Scale (VAS)

  The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.

  2 Week, 6 Week, 3 Month, 6 Month and 1 Year Post Surgery

• Fractures Fully Healed

  Radiographic evidence of boney healing of the distal radius. This outcome measure is reported as the number of participants in each group with fully healed fractures at the designated time point.

  6 weeks post surgery

Secondary Outcomes (5)

• QuickDASH

  2 Week, 6 Week, 3 Month, 6 Month and 1 Year Post Surgery

• Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity)

  2 Weeks, 6 Weeks, 3 Months, 6 Months and 1 Year post surgery

• Grip Strength

  2 Week, 6 Week and 3 Month Post Surgery

• Key Pinch Strength

  2 weeks, 6 weeks, and 3 months post surgery

• Wrist Range of Motion (ROM)

  2 weeks, 6 weeks and 3 months post surgery

Study Arms (2)

Acetaminophen

ACTIVE COMPARATOR

Acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.

Drug: Acetaminophen

NSAID

EXPERIMENTAL

NSAID administered ibuprofen 400-800 mg, up to three times a day and acetaminophen with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day as needed for pain control. Oxycodone 5mg 1-2 tablets q4-6 hours will be available for breakthrough pain.

Drug: Ibuprofen

Interventions

Ibuprofen DRUG

NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control

Also known as: Motrin, Advil

NSAID

Acetaminophen DRUG

Control Group - will be administered acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day.

Also known as: tylenol

Acetaminophen

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18
• Distal radius fracture

You may not qualify if:

• Contraindication to NSAID use (ie, cannot tolerate, gastritis, ulcers, chronic kidney disease stage 4 or higher, bleeding disorders/thrombocytopenia)
• Inability to take breakthrough medications
• Regular use of NSAIDs
• Regular use of Narcotics
• Open fracture
• Other orthopaedic injuries (polytrauma)
• Pathologic fracture
• Previous injury to the bone
• Pregnant or plan to become pregnant
• Unable to sign informed consent

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Vicki L Jones
• Organization: UMissouri

jonesvicki@health.missouri.edu

573-882-7583

Study Officials

• Daniel A London, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Orthopedic Surgery

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: November 21, 2018
• Study Start: January 2, 2019
• Primary Completion: March 24, 2022
• Study Completion: March 24, 2022
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-08

Locations

US (1)