The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures

Completed · Not applicable

Conditions studied: Elbow Fracture

In brief

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.

Key facts

Study ID: NCT01328782
Run by: University of Colorado, Denver
People needed: 124
Starts: 2008-06-01
Expected to finish: 2011-06-01
Last updated by the study team: 2015-06-23

Who can join

Age: 4 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

ASA class I, II or III
Patients 4-12 years old requiring general anesthesia for closed reduction and percutaneous pinning (CRPP) of supracondylar type elbow fractures (SCEFx).
Patients able to understand and report their pain with the Faces Pain Scale Revised

You may not qualify if…

Medical contraindications to analgesic therapy.
Known allergy or sensitivity to analgesic agent.
Clinical evidence of skin inflammation precluding the 'clean' area at the site of injection.
Patients lacking the cognitive understanding to report their pain with the FSP-R (unable to complete seriation task).
Patients necessitating open reduction due to inability to obtain an acceptable closed reduction.
Comorbid diagnosis of other traumatic injury that causes any local and or global pain.
Patients presenting to ER with neurovascular injury or compartment syndrome due to fracture.
For patients in either of the two intervention arms, if after three attempts, the intraarticular injection is not successful, the patient will be dropped from the study.
Patients admitted for complications directly related to the surgery will be dropped from analysis. Any such event will be immediately reported to COMIRB with in five business days. However, patients admitted due to a late afternoon/evening surgery and patients admitted for standard observational purposes unrelated to surgical complications, will not be dropped from the study.
Known drug allergy to oxycodone and or acetaminophen.
Children 4-7 years old weighing less than 14 kg (Weight exclusion criteria is based on a 4 year old female that is below the fifth percentile for weight, per the Center for Disease Control Growth Charts).
Children 8-12 years old weighing less than 20 kg (Weight exclusion criteria based on an 8 year old female that is below the fifth percentile for weight, per the Center for Disease Control Growth Charts).

Where it is running

The Children's Hospital — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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