Supracondylar Post-Operative Pain Study

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age4-12
SponsorUniversity of California, Los Angeles

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: IbuprofenExperimental treatment 2 interventions
Group B: OxycodoneActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Faces Pain Scale-Revised (FPSR)

Self reported measure of pain on scale 0-10. 0 = no pain; 10 = worst pain imaginable

Time frame
24 to 48 hours post-operatively

Secondary outcomes

1

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.

Time frame
1 week at first post-operative follow-up

Other outcomes

1

Pain medication logs

Self report take home medication logs recording the time, type, dosage, and side effects of medication

Time frame
Immediately after surgery at time of randomization until the patient returns for 1st post-operative visit, 7-10 days post-operatively, assessed up to 10 days.

Sponsors and contacts

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