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

Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture: A Prospective, Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Drug: Acetaminophen; Drug: Ibuprofen

Detailed Description

In the United States, drug overdose deaths and opioid-involved deaths continue to increase, quadrupling since 1999; six out of ten drug overdose deaths involve an opioid. Overdoses from prescription opioids are a driving factor in the 15-year increase in opioid overdose deaths. The amount of prescription opioids sold to pharmacies, hospitals, and doctors' offices has drastically risen, yet there had not been an overall change in the amount of pain that Americans reported. Deaths from prescription opioids-drugs like oxycodone, hydrocodone, and methadone-have more than quadrupled since 1999.

Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to control both postoperative pain and pain associated with some orthopaedic injuries in children and adults with certain orthopaedic injuries. Further, the use of NSAIDs for pain control has been shown to lessen the use of narcotic pain medications, the adverse effects of which are well known. With the current opioid epidemic, more research is needed to determine strategies to reduce opioid use in patients with orthopaedic injuries. Chapman et al. showed that NSAIDs can be used effectively to reduce postoperative pain and narcotic use in patients who had undergone carpal tunnel release. Although distal radius fractures are one of the most common fractures, no studies have examined the effect of NSAIDs on distal radius fracture pain. The purpose of this study is to compare pain and narcotic pain medication use in patients who have had distal radius fractures in patients who use NSAIDs to those who do not.

To the authors' knowledge, there have been no clinical prospective, randomized studies to evaluate the effect that NSAIDs have on patients with distal radius fractures. 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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18
• Distal radius fracture

Exclusion Criteria:

• Contraindication to NSAID use (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-operative Acetaminophen; Acetaminophen will be given to participants for pain control following their injury.	Drug: Acetaminophen; 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.; Other Names: tylenol
Active Comparator: Operative Acetaminophen; Acetaminophen will be given to participants for pain control following their surgery for arm fracture.	Drug: Acetaminophen; 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.; Other Names: tylenol
Experimental: Non-operative NSAID; Ibuprofen will be given to participants for pain control following their injury.	Drug: Ibuprofen; NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control; Other Names: Advil; Motrin
Experimental: Operative NSAID; Ibuprofen will be given to participants following their surgery for arm fracture.	Drug: Ibuprofen; NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control; Other Names: Advil; Motrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 weeks
Number of oxycodone tablets	The number and dosing of oxycodone tablets taken per participant for breakthrough pain will be recorded.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extent of Wrist Range of Motion (ROM)	The patient will be asked to move their wrist and their ROM will be measured with a goniometer.	3 month
Quality of Pinch and Grip Strength	The patient will be asked to grip and pinch a dynamometer to measure grip and pinch strength.	3 months
Quality of Pinch Strength	The patient will be asked to pinch a dynamometer to measure pinch strength.	3 months

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Jay T Bridgeman, MD, DDS, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Actual): March 24, 2022
• Study Completion (Actual): March 24, 2022

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Fractures, Bone; Radius Fractures; Wrist Fractures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: 2009129

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No