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Effects of Additional Fentanyl to Epidural Bupivacaine for Post-Thoracotomy Pain in Neonates
This study has been completed.
Sponsored by: Children's Hospital of Philadelphia
Information provided by: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00286143
  Purpose

The study exams whether adding an opioid to the epidural infusion of a local anesthetic in neonates will significantly improve the quality of the postoperative analgesia.


Condition Intervention Phase
Congenital Cystic Adenomatoid Malformation
Drug: Fentanyl
Phase III

Drug Information available for: Fentanyl Citrate Fentanyl Bupivacaine Bupivacaine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: Evaluation of Effects of Additional Fentanyl to Epidural Bupivacaine for Post-Thoracotomy Pain in Neonates on Perioperative Outcome

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Evaluate the difference in amount of Intravenous nalbuphine required after thoracotomy for lung resection in patients receiving epidural bupivacaine + fentanyl versus patients receiving epidural bupivacaine. [ Time Frame: First 48 hours post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. Determine in two treatment groups the difference in pain scores as measured by the CRIES pain scale ,the length of stay,the incidence of side effects (respiratory depression, bradypnea, bradycardia and urinary retention). [ Time Frame: 48 hours post-operatively ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: February 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
Fentanyl added to Bupivacaine via epidural catheter.
Drug: Fentanyl
Fentanyl is added to epidural Bupivacaine to be administered to neonates having thoracotomy for lung resections.

Detailed Description:

The purpose of this study is to evaluate the best pain medication to be infused in the epidural catheter. At CHOP, the medication infused in the epidural catheter following a chest operation in neonates is a local anesthetic (bupivacaine). However, even with this continuous infusion, neonates still require multiple doses of intravenous opioids (i.e. morphine) because of persistent or constant pain. The administration of intravenous opioids in neonates can have many side effects, such as respiratory depression (reduced breathing rate), sedation, urinary retention (inability to pass urine), itching, nausea and vomiting It has been well documented that by adding a small dose of any opioid to a local anesthetic given through an epidural catheter, the feeling of postoperative pain can be significantly improved in older children and in adults. It is not known whether the addition of an opioid to a local anesthetic is beneficial in neonates. In this study, we are comparing the standard local anesthetic (bupivacaine) with a combination of bupivacaine and a small dose of an opioid (fentanyl).

This is a randomized study and the type of medication given into the epidural catheter will be chosen on the day of the operation by a random drawing (like flipping a coin). Your child could receive one of the following:

  1. bupivacaine 0.1%
  2. bupivacaine 0.1% with fentanyl 2mcg/ml Neither you nor your doctors will know which arm of the study your child is in. In case of emergency, the pharmacy can tell your doctor what medication your child is receiving.
  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Infants 0-6 months of age who require a thoracotomy for lung resection.
  2. Parents accept the placement of an epidural catheter.

Exclusion Criteria:

  1. Premature infants
  2. Patients allergic to fentanyl and/or bupivacaine.
  3. Known medical contraindications. -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286143

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Arjunan Ganesh, MD Children's Hospital of Philadelphia
  More Information

Responsible Party: Children's Anesthesiology Associates ( Arjunan Ganesh, MBBS )
Study ID Numbers: 2004-10-3988
Study First Received: February 1, 2006
Last Updated: July 14, 2008
ClinicalTrials.gov Identifier: NCT00286143  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Fentanyl
Respiratory Tract Diseases
Lung Diseases
Bupivacaine
Pain
Cystic Adenomatoid Malformation of Lung, Congenital
Congenital Abnormalities
Cystic adenomatoid malformation of lung

Additional relevant MeSH terms:
Anesthetics, Intravenous
Respiratory System Abnormalities
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Anesthetics, Local
Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009