Effects of Additional Fentanyl to Epidural Bupivacaine for Post-Thoracotomy Pain in Neonates - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Evaluation of Effects of Additional Fentanyl to Epidural Bupivacaine for Post-Thoracotomy Pain in Neonates on Perioperative Outcome

Resource links provided by NLM:

Drug Information available for: Bupivacaine hydrochloride Bupivacaine Fentanyl Fentanyl Citrate

U.S. FDA Resources

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
Active Comparator: A 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. Other Name: Actiq®; Duragesic®; Fentora™; Ionsys™; Sublimaze®

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:

bupivacaine 0.1%
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:

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

Exclusion Criteria:

Premature infants
Patients allergic to fentanyl and/or bupivacaine.
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

Publications:

Ganesh A, Adzick NS, Foster T, Cucchiaro G. Efficacy of addition of fentanyl to epidural bupivacaine on postoperative analgesia after thoracotomy for lung resection in infants. Anesthesiology. 2008 Nov;109(5):890-4.

Responsible Party:	Arjunan Ganesh, MBBS, Children's Anesthesiology Associates
ClinicalTrials.gov Identifier:	NCT00286143 History of Changes
Other Study ID Numbers:	2004-10-3988
Study First Received:	February 1, 2006
Last Updated:	September 14, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Congenital Abnormalities
Cystic Adenomatoid Malformation of Lung, Congenital
Lung Diseases
Respiratory Tract Diseases
Respiratory System Abnormalities
Bupivacaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Analgesics
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 09, 2012