About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Closed supracondylar humerus fracture
Isolated supracondylar humerus fracture
Type II and III supracondylar humerus fracture
Fractures treated with closed reduction percutaneous pinning
Disqualifiers
Fractures with concomitant vascular injury
Fractures with concomitant neurologic deficit
Pathologic fractures
Fractures with concomitant injuries (multiple trauma)
Trial design
Parallel
Treatments tested in this trial
Ibuprofen
DrugPost-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
Oxycodone
DrugPost-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
Acetaminophen
DrugPost-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
Treatment groups
Trial outcomes
Primary outcomes
Faces Pain Scale-Revised (FPSR)
Self reported measure of pain on scale 0-10. 0 = no pain; 10 = worst pain imaginable
Secondary outcomes
Total Quality Pain Management Instrument
Questionnaire used to measure the quality of children's post-operative pain management in which parents and patients are asked multiple questions re: post-operative pain management including domains in pain experience, pain relief, adverse effects, future analgesic use. The majority of the questions are binary, but there are a few questions that include a mild, moderate, severe option. There is no numerical output, and the subscales are not combined.
Other outcomes
Pain medication logs
Self report take home medication logs recording the time, type, dosage, and side effects of medication
Sponsors and contacts
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