Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03749616 |
| Other study ID # |
2009129 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
January 2, 2019 |
| Est. completion date |
March 24, 2022 |
Study information
| Verified date |
October 2023 |
| Source |
University of Missouri-Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
