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Trial record 5 of 475 for:    CANDOX OR CAREXIL OR OXYCONTIN OR OXYNORM OR RELTEBON OR LEVERAXO OR LONGTEC OR OXAYDO OR SHORTEC OR OXELTRA OR OXYLAN OR ZOMESTINE OR OXYCODONE HYDROCHLORIDE OR ROXYBOND OR ROXICODONE OR LYNLOR OR OXECTA OR ABTARD OR DOLOCODON PR

Supracondylar Post-Operative Pain Study

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ClinicalTrials.gov Identifier: NCT03759028
Recruitment Status : Not yet recruiting
First Posted : November 29, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Rachel Thompson, MD, University of California, Los Angeles

Brief 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.

Condition or disease Intervention/treatment Phase
Supracondylar Humerus Fracture Drug: Ibuprofen Drug: Oxycodone Drug: Acetaminophen Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double blinded, randomized trial
Masking: Double (Participant, Investigator)
Masking Description: Randomization envelopes used to allocate treatment groups
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Acetaminophen and Ibuprofen Versus Acetaminophen and Oxycodone for Postoperative Pain Control in Operative Pediatric Supracondylar Humerus Fracture
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : July 1, 2019


Arm Intervention/treatment
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).
Drug: Ibuprofen
Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
Other Name: Advil, Motrin

Drug: Acetaminophen
Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
Other Name: Tylenol, Paracetamol

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).
Drug: Oxycodone
Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
Other Name: roxicodone

Drug: Acetaminophen
Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
Other Name: Tylenol, Paracetamol




Primary Outcome Measures :
  1. Faces Pain Scale-Revised (FPSR) [ Time Frame: 24 to 48 hours post-operatively ]
    Self reported measure of pain on scale 0-10. 0 = no pain; 10 = worst pain imaginable


Secondary Outcome Measures :
  1. Total Quality Pain Management Instrument [ Time Frame: 1 week at first post-operative follow-up ]
    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 Outcome Measures:
  1. Pain medication logs [ 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. ]
    Self report take home medication logs recording the time, type, dosage, and side effects of medication



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Closed supracondylar humerus fracture
  • Isolated supracondylar humerus fracture
  • Type II and III supracondylar humerus fracture
  • Fracutres treated with closed reduction percutaneous pinning

Exclusion Criteria:

  • Fractures with concomitant vascular injury
  • Fractures with concomitant neurologic deficit
  • Pathologic fractures
  • Fractures with concomitant injuries (multiple trauma)
  • Fractures with swelling requiring post-operative hospitalization for monitoring
  • Known history of allergies to acetaminophen, ibuprofen or oxycodone
  • Patients with developmental delay that would preclude participation in the visual analog Faces Pain Scale-Revised
  • Patients with intellectual disability that would preclude participation in the visual analog Faces Pain Scale-Revised
  • History of suspected child abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759028


Contacts
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Contact: Jared M Alswang 2137426537 jalswang@mednet.ucla.edu
Contact: Sierra M Pinal 2137421057 spinal@mednet.ucla.edu

Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Rachel M Thompson, MD UCLA/OIC
  Study Documents (Full-Text)

Documents provided by Rachel Thompson, MD, University of California, Los Angeles:
Study Protocol  [PDF] November 14, 2018


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Responsible Party: Rachel Thompson, MD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03759028     History of Changes
Other Study ID Numbers: IRB# 18-001158
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Rachel Thompson, MD, University of California, Los Angeles:
closed reduction percutaneous pinning
post-operative pain control
opiod
pediatric
elbow fracture

Additional relevant MeSH terms:
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Oxycodone
Fractures, Bone
Pain, Postoperative
Humeral Fractures
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Arm Injuries
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants