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The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gaia Georgopoulos, Children's Hospital Colorad
ClinicalTrials.gov Identifier:
NCT01328782
First received: September 22, 2010
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Elbow Fracture
 Drug: Oxycodone with Acetaminophen
Drug: Bupivacaine 0.25%
Drug: Ropivacaine 0.20%

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Children's Hospital Colorado:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Need for IV Morphine of Fentanyl [ Time Frame: First 120 minutes after the end of surgery (surgery close time) ] [ Designated as safety issue: No ]
    Indicates that number of subjects that were in severe pain and thus required IV morphine and/or fentanyl.


Enrollment: 124
Study Start Date: June 2008
Study Completion Date: June 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%
  • 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
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%
  • 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
Other Name: Naropin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328782

Locations
United States, Colorado
The Children's Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
Children's Hospital Colorado
  More Information

No publications provided

Responsible Party: Gaia Georgopoulos, Associate Professor, Orthopaedic Surgery, Children's Hospital Colorad
ClinicalTrials.gov Identifier: NCT01328782     History of Changes
Other Study ID Numbers: 07-1190
Study First Received: September 22, 2010
Results First Received: February 27, 2012
Last Updated: June 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Colorado:
elbow fracture
supracondylar elbow fracture
elbow
 fracture
pain management
pediatric

Additional relevant MeSH terms:
Fractures, Bone
Pain, Postoperative
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Acetaminophen
Oxycodone
Bupivacaine
Ropivacaine
Antipyretics
Physiological Effects of Drugs
 Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Narcotics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 23, 2013