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NCT01328782 · ClinicalTrials.gov registry record · NA
The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures
A NA study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 124
- Enrollment target
NCT01328782: Completed NA study, sponsored by University of Colorado, Denver.
NCT01328782 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 124 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01328782, a NA study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 124 participants
- Enrollment target
Study 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.
Primary Outcome
The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.
Interventions
- DRUG Bupivacaine 0.25%
- DRUG Oxycodone with Acetaminophen
- DRUG Ropivacaine 0.20%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2008-06 |
| Est. Completion | 2011-06 |
| Phase | NA |
What the finished NCT01328782 record still lists
NCT01328782 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 3 interventions - of which Bupivacaine 0.25% is the first listed.
NCT01328782 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01328782 about?
NCT01328782 is a clinical study titled "The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures". 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, y...
What is the current status of trial NCT01328782?
This trial is currently completed. It is a NA study. The enrollment target is 124 participants. The study started on 2008-06. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01328782?
The interventions under investigation include: Bupivacaine 0.25% (DRUG), Oxycodone with Acetaminophen (DRUG), Ropivacaine 0.20% (DRUG).
Who is sponsoring clinical trial NCT01328782?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01328782's enrollment target sits among peer trials
124 758th of 2000 higher than 1,239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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