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

Primary Purpose

Distal Radius Fracture

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
Acetaminophen
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Missouri Health Care

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

Non-operative Acetaminophen

Operative Acetaminophen

Non-operative NSAID

Operative NSAID

Arm Description

Acetaminophen will be given to participants for pain control following their injury.

Acetaminophen will be given to participants for pain control following their surgery for arm fracture.

Ibuprofen will be given to participants for pain control following their injury.

Ibuprofen will be given to participants following their surgery for arm fracture.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Quality of Pinch and Grip Strength
The patient will be asked to grip and pinch a dynamometer to measure grip and pinch strength.
Quality of Pinch Strength
The patient will be asked to pinch a dynamometer to measure pinch strength.

Full Information

First Posted
September 26, 2018
Last Updated
October 2, 2023
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03749616
Brief Title
Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture
Acronym
Adult NSAID
Official Title
Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture: A Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
March 24, 2022 (Actual)
Study Completion Date
March 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-operative Acetaminophen
Arm Type
Active Comparator
Arm Description
Acetaminophen will be given to participants for pain control following their injury.
Arm Title
Operative Acetaminophen
Arm Type
Active Comparator
Arm Description
Acetaminophen will be given to participants for pain control following their surgery for arm fracture.
Arm Title
Non-operative NSAID
Arm Type
Experimental
Arm Description
Ibuprofen will be given to participants for pain control following their injury.
Arm Title
Operative NSAID
Arm Type
Experimental
Arm Description
Ibuprofen will be given to participants following their surgery for arm fracture.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Motrin, Advil
Intervention Description
NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
tylenol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intensity of pain: Visual Analog Scale (VAS)
Description
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.
Time Frame
2 weeks
Title
Number of oxycodone tablets
Description
The number and dosing of oxycodone tablets taken per participant for breakthrough pain will be recorded.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Extent of Wrist Range of Motion (ROM)
Description
The patient will be asked to move their wrist and their ROM will be measured with a goniometer.
Time Frame
3 month
Title
Quality of Pinch and Grip Strength
Description
The patient will be asked to grip and pinch a dynamometer to measure grip and pinch strength.
Time Frame
3 months
Title
Quality of Pinch Strength
Description
The patient will be asked to pinch a dynamometer to measure pinch strength.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay T Bridgeman, MD, DDS
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri Health Care
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

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

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