The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures
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|ClinicalTrials.gov Identifier: NCT01328782|
Recruitment Status : Completed
First Posted : April 5, 2011
Results First Posted : June 13, 2012
Last Update Posted : June 23, 2015
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:
- with oral pain medication
- with oral pain medicine and an intraarticular shot (a shot into the elbow joint) of bupivacaine (a "numbing" drug) or
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Elbow Fracture||Drug: Oxycodone with Acetaminophen Drug: Bupivacaine 0.25% Drug: Ropivacaine 0.20%||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||June 2011|
Active Comparator: The group receiving oral pain medicine
This group will receive Oxycodone with Acetaminophen orally
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.
Other Name: Percocet
Active Comparator: The group receiving bupivacaine and oral pain medicine
This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
Drug: Bupivacaine 0.25%
Other Name: Marcaine
Active Comparator: The group receiving ropivacaine and oral pain medicine
This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
Drug: Ropivacaine 0.20%
Other Name: Naropin
- The Faces Pain Scale-Revised (FSP-R) Scores (Scored 0-10). [ Time Frame: Will be obtained 30 - 60 minutes after arrival to the recovery room ]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.
- Total Quality Pain Management Survey (TQPM) Scores for Questions # 16: Child's Current Level of Pain, Question # 17: Child's Worst Level of Pain When Moving Around After Surgery and Question # 18: Child's Worst Level of Pain While Resting [ Time Frame: Will be obtained from parent(s) 120 minutes after arrival to the recovery room ]Total quality pain management survey is validated survey used to assess parents' perceptions of their child's pain. Pain is assessed on a dimensionless 10 pt likert scale from 0 (no pain) to 10 (severe pain). Greater pain scores are indicative or more severe pain.
- Time (in Minutes) to First Narcotic Administration [ Time Frame: first 72 hours after surgery close time ]
- Total Dosage in Morphine Equivalents (mg/kg) of All Analgesics Received in Prior to Discharge [ Time Frame: Analgesic data collected during first four hours following the end of surgery (surgery close) ]
- Need for IV Morphine of Fentanyl [ Time Frame: First 120 minutes after the end of surgery (surgery close time) ]Indicates that number of subjects that were in severe pain and thus required IV morphine and/or fentanyl.
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): NCT01328782
|United States, Colorado|
|The Children's Hospital|
|Aurora, Colorado, United States, 80045|