RECRUITING

Supracondylar Post-Operative Pain Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Controlled Trial of Acetaminophen and Ibuprofen Versus Acetaminophen and Oxycodone for Postoperative Pain Control in Operative Pediatric Supracondylar Humerus Fracture

Quick Facts

Study Start:2019-02-26
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03759028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Closed supracondylar humerus fracture
  2. * Isolated supracondylar humerus fracture
  3. * Type II and III supracondylar humerus fracture
  4. * Fracutres treated with closed reduction percutaneous pinning
  1. * Fractures with concomitant vascular injury
  2. * Fractures with concomitant neurologic deficit
  3. * Pathologic fractures
  4. * Fractures with concomitant injuries (multiple trauma)
  5. * Fractures with swelling requiring post-operative hospitalization for monitoring
  6. * Known history of allergies to acetaminophen, ibuprofen or oxycodone
  7. * Patients with developmental delay that would preclude participation in the visual analog Faces Pain Scale-Revised
  8. * Patients with intellectual disability that would preclude participation in the visual analog Faces Pain Scale-Revised
  9. * History of suspected child abuse

Contacts and Locations

Study Contact

Jared M Alswang
CONTACT
2137426537
jalswang@mednet.ucla.edu
Christina K Sun, MS
CONTACT
2137421057
CKSun@mednet.ucla.edu

Principal Investigator

Rachel M Thompson, MD
PRINCIPAL_INVESTIGATOR
UCLA/OIC

Study Locations (Sites)

Orthopaedic Institute for Children
Los Angeles, California, 90007
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Rachel M Thompson, MD, PRINCIPAL_INVESTIGATOR, UCLA/OIC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-02-26
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2019-02-26
Study Completion Date2025-06-01

Terms related to this study

Keywords Provided by Researchers

  • closed reduction percutaneous pinning
  • post-operative pain control
  • opiod
  • pediatric
  • elbow fracture

Additional Relevant MeSH Terms

  • Supracondylar Humerus Fracture