Supracondylar Post-Operative Pain Study

Conditions

• Supracondylar Humerus Fracture

Eligibility Criteria

Sex

ALL

Age

4 Years - 12 Years

Healthy Volunteers

Not accepted

Interventions

• Ibuprofen — DRUG
  Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
• Oxycodone — DRUG
  Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
• Acetaminophen — DRUG
  Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.

Study Details

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.

Key Dates

Start date

Feb 26, 2019

Status verified

Apr 2026

Primary completion

Dec 1, 2027

Completion

Dec 20, 2027

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ibuprofen
  This group is given acetaminophen (liquid oral medication, 15mg/kg/dose every 6 hours as needed, max 90mg/kg/day) as the first-line pain medication, and as needed ibuprofen for breakthrough pain (liquid oral medication, 10mg/kg/dose every 8 hours as needed, max dose 40mg/kg/day).
• Active Comparator: Oxycodone
  This group is given acetaminophen (liquid oral medication, 15mg/kg/dose every 6 hours as needed, max 90mg/kg/day) as the first-line pain medication, and as needed oxycodone for breakthrough pain (liquid oral medication, 0.1mg/kg/dose every 6 hours as needed).

Primary Outcome Measure

Faces Pain Scale-Revised (FPSR) [ Time Frame: 24 to 48 hours post-operatively ]

Central Contacts

• Lindsey Han, BA
  2137421074
  [email protected]

Locations (1)

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