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NCT03759028 · ClinicalTrials.gov registry record · Phase 4
Supracondylar Post-Operative Pain Study
A Phase 4 study of Supracondylar Humerus Fracture, sponsored by University of California, Los Angeles.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT03759028: Recruiting Phase 4 study of Supracondylar Humerus Fracture, sponsored by University of California, Los Angeles.
NCT03759028 is a Phase 4 study of Supracondylar Humerus Fracture that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 90 participants, below the 158-participant average among 3 other Supracondylar Humerus Fracture trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03759028, a Phase 4 study of Supracondylar Humerus Fracture, is actively recruiting participants, sponsored by University of California, Los Angeles.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study to investigate post-operative pain control in pediatric patients with closed supracondylar humerus fracture who undergo closed reduction and percutaneous pinning. Currently, it is standard of care that patients receive a narcotic prescription for post-operative pain control. All patients will initially be seen in our pediatric urgent care and recruited at the time of surgery. Patients will be randomized to receiving acetaminophen and ibuprofen or acetaminophen and oxycodone. Parents will not be blinded to the acetaminophen but both investigators, parents and the patients will be blinded to the study drug (ibuprofen or oxycodone). Pain level will be assessed using the Wong-Baker FACES scale and parents will be asked to fill out a questionnaire regarding their satisfaction with the surgery and pain control. Parents will also fill out a medication log until the patient no longer requires pain medication. The duration of participation in the study is approximately 1 week and requires 2 visits (time of recruitment at surgery to 1st post-op visit). This study is being conducted in hopes of reducing opioid prescription after surgical fixation of uncomplicated supracondylar humerus fractures if our study can show that patient's pain levels post-operatively and parent/patient satisfaction are unchanged or improved in the acetaminophen and ibuprofen arm.
Primary Outcome
Self reported measure of pain on scale 0-10. 0 = no pain; 10 = worst pain imaginable
Conditions Studied
Interventions
- DRUG Acetaminophen
- DRUG Ibuprofen
- DRUG Oxycodone
Study Locations (1)
California
- Orthopaedic Institute for Children - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2019-02-26 |
| Est. Completion | 2027-12-20 |
| Phase | Phase 4 |
What NCT03759028 shows while recruiting
NCT03759028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 158-participant average among 3 other Supracondylar Humerus Fracture trials with a reported enrollment target (43% lower).
The record links to 1 condition, with Supracondylar Humerus Fracture appearing as the primary indexed condition, and to 3 interventions - of which Acetaminophen is the first listed.
NCT03759028 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03759028 about?
NCT03759028 is a clinical study titled "Supracondylar Post-Operative Pain Study". The purpose of this study to investigate post-operative pain control in pediatric patients with closed supracondylar humerus fracture who undergo closed reduction and percutaneous pinning. Currently, it is standard of care that patients receive a narcotic prescription for post-operative pain control...
What is the current status of trial NCT03759028?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2019-02-26. Estimated completion is 2027-12-20.
What conditions does trial NCT03759028 study?
This clinical trial studies the following conditions: Supracondylar Humerus Fracture.
What interventions are being tested in trial NCT03759028?
The interventions under investigation include: Acetaminophen (DRUG), Ibuprofen (DRUG), Oxycodone (DRUG).
Who is sponsoring clinical trial NCT03759028?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03759028 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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