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

• ClinicalTrials.gov Identifier: NCT00286143
• Recruitment Status: Completed
• First Posted: February 3, 2006
• Last Update Posted: September 16, 2009
• Sponsor: Children's Hospital of Philadelphia
• Information provided by: Children's Hospital of Philadelphia

Tracking Information

• First Submitted Date: February 1, 2006
• First Posted Date: February 3, 2006
• Last Update Posted Date: September 16, 2009
• Study Start Date: February 2005
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 25, 2007): 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 ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures (submitted: September 25, 2007): 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 ]
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Additional Fentanyl to Epidural Bupivacaine for Post-Thoracotomy Pain in Neonates
• Official Title: Evaluation of Effects of Additional Fentanyl to Epidural Bupivacaine for Post-Thoracotomy Pain in Neonates on Perioperative Outcome
• Brief Summary: 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.

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
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Congenital Cystic Adenomatoid Malformation

Intervention

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®

Study Arms

Active Comparator: A

Fentanyl added to Bupivacaine via epidural catheter.

Intervention: Drug: Fentanyl

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 25, 2007): 32
• Original Enrollment: Not Provided
• Actual Study Completion Date: December 2007
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Eligibility 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. -

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 6 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00286143
• Other Study ID Numbers: 2004-10-3988
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Arjunan Ganesh, MBBS, Children's Anesthesiology Associates
• Study Sponsor: Children's Hospital of Philadelphia
• Collaborators: Not Provided

Investigators

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

• PRS Account: Children's Hospital of Philadelphia
• Verification Date: September 2009