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

Evaluation of Effects of Additional Fentanyl to Epidural Bupivacaine for Post-Thoracotomy Pain in Neonates on Perioperative Outcome

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.

Study Overview

• Status: Completed
• Conditions: Congenital Cystic Adenomatoid Malformation
• Intervention / Treatment: Drug: Fentanyl

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Actiq®; Duragesic®; Fentora™; Ionsys™; Sublimaze®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	First 48 hours post-operatively

Secondary Outcome Measures

Outcome Measure	Time Frame
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).	48 hours post-operatively

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Arjunan Ganesh, MD, Children's Hospital of Philadelphia

Publications and helpful links

General 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. doi: 10.1097/ALN.0b013e31818aa6cb.

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: February 1, 2006
• First Submitted That Met QC Criteria: February 1, 2006
• First Posted (Estimate): February 3, 2006

Study Record Updates

• Last Update Posted (Estimate): September 16, 2009
• Last Update Submitted That Met QC Criteria: September 14, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Congenital Abnormalities; Respiratory System Abnormalities; Cystic Adenomatoid Malformation of Lung, Congenital; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: 2004-10-3988