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The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures

NCT01328782 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2015-06-23

Study results available
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Summary

The goal of this study is to compare different ways of treating pain after surgery. This research study involves subjects who have a supracondylar elbow fracture and need surgery. This type of fracture occurs when the humerus (upper arm bone) is broken just above the elbow. Like any other surgery, you can expect that you will feel pain in the hours or days after the operation. Currently, despite the common occurrence of this surgery, there is not a standard way to treat and or prevent any of the pain afterwards.

At this hospital, oral (take by mouth) pain medicine is commonly used to treat pain after this surgery.

In this study, pain will be treated in one of the following ways:

1. with oral pain medication
2. with oral pain medicine and an intraarticular shot (a shot into the elbow joint) of bupivacaine (a "numbing" drug) or
3. with oral pain medicine and an intraarticular shot of ropivacaine (another "numbing" drug). The shots will be given during surgery. Your participation will help us find out which of these three pain control methods works the best.

The correct dosages of all drugs will be safely prescribed by the doctor on an individual basis and all drugs will be used under the careful watch of your attending physician. All the drugs used this study are approved by the FDA for use in adults but they are not specifically approved for use in children. However, nearly 7 out of every 10 drugs approved for adults are not specifically approved by the FDA for use in children. All drugs used in this study will be used in a way that is considered to be safe and reasonable by the Children's Hospital.

Conditions

  • Elbow Fracture

Interventions

DRUG

Oxycodone with Acetaminophen

0.1- 0.15 mg/kg (oxycodone) every 4-6 hours as needed. Pills: 325 mg acetaminophen: 5 mg oxycodone per tablet. Liquid: 325 mg acetaminophen:5 mg oxycodone per 5 mL.

DRUG

Bupivacaine 0.25%

* Up to 4 ml at 0.25 % given to .. In toxic doses can lead to irregular heart beat, patients aged 4-7 (dose will be irregular heart rate and cardiac arrest. (This no greater than 0.71 mg/kg) * Up to 5 ml at 0.25 % by volume solution will be given to patients aged 8-12 (dose will be no greater than 0.63 mg/kg) * All doses given will be significantly less then maximum allowable dose of 2.5- 3.0 mg/kg

DRUG

Ropivacaine 0.20%

* Up to 4 ml at 0.20 % given to patients aged 4-7 (dose will be no greater than 0.57 mg/kg) * Up to 5 ml at 0.20 % by volume solution will be given to patients aged 8-1(dose will be no greater than 0.50 mg/kg) * All doses given will be significantly less then maximum allowable dose of 2.5- 3.0 mg/kg

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-08-31
Completion
2011-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01328782 on ClinicalTrials.gov