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

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ClinicalTrials.gov Identifier: NCT03749616
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jay T. Bridgeman, MD, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Distal Radius Fracture Drug: Ibuprofen Drug: Acetaminophen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture: A Prospective, Randomized Study
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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:
  • Motrin
  • Advil

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:
  • Motrin
  • Advil




Primary Outcome Measures :
  1. Intensity of pain: Visual Analog Scale (VAS) [ Time Frame: 2 weeks ]
    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. Number of oxycodone tablets [ Time Frame: 2 weeks ]
    The number and dosing of oxycodone tablets taken per participant for breakthrough pain will be recorded.


Secondary Outcome Measures :
  1. Extent of Wrist Range of Motion (ROM) [ Time Frame: 3 month ]
    The patient will be asked to move their wrist and their ROM will be measured with a goniometer.

  2. Quality of Pinch and Grip Strength [ Time Frame: 3 months ]
    The patient will be asked to grip and pinch a dynamometer to measure grip and pinch strength.

  3. Quality of Pinch Strength [ Time Frame: 3 months ]
    The patient will be asked to pinch a dynamometer to measure pinch strength.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18
  • Distal radius fracture

Exclusion Criteria:

  • Contraindication to NSAID use (cannot tolerate, gastritis, ulcers)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749616


Contacts
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Contact: Stacee Clawson 573-884-9017 clawsons@health.missouri.edu
Contact: Lauren Livesay livesayl@health.missouri.edu

Locations
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United States, Missouri
University of Missouri Health Care Recruiting
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Jay T Bridgeman, MD, DDS University of Missouri-Columbia
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Responsible Party: Jay T. Bridgeman, MD, Professor, Orthopedic Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03749616    
Other Study ID Numbers: 2009129
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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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
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action