Clinical trial NCT03749616: Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture
Official title: Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture: A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Distal Radius Fracture
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Distal radius fracture

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Oxycodone Tablets Used for Breakthrough Pain.
timeFrame: 2 weeks
measure: Intensity of Pain: Visual Analog Scale (VAS)
timeFrame: 2 Week, 6 Week, 3 Month, 6 Month and 1 Year Post Surgery
measure: Fractures Fully Healed
timeFrame: 6 weeks post surgery
Secondary outcomes:
measure: QuickDASH
timeFrame: 2 Week, 6 Week, 3 Month, 6 Month and 1 Year Post Surgery
measure: Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity)
timeFrame: 2 Weeks, 6 Weeks, 3 Months, 6 Months and 1 Year post surgery
measure: Grip Strength
timeFrame: 2 Week, 6 Week and 3 Month Post Surgery
measure: Key Pinch Strength
timeFrame: 2 weeks, 6 weeks, and 3 months post surgery
measure: Wrist Range of Motion (ROM)
timeFrame: 2 weeks, 6 weeks and 3 months post surgery
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Daniel A London, MD
role: PRINCIPAL_INVESTIGATOR
References: