drugset / Trial / NCT01328782

The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures

NCT01328782

Completed 124 enrolled University of Colorado, Denver
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2008-06
Primary completion
2010-08
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 0.25 % Other
Comparator Ropivacaine Other / unclassified 0.2 % Other
Comparator Acetaminophen Small molecule 325 mg Oral
Comparator Oxycodone Other / unclassified 0.1 mg/kg Oral
Comparator Oxycodone Other / unclassified 0.15 mg/kg Oral

Indications

No indication recorded.