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

Children's Hospital of Philadelphia (CHOP)

Status and phase: Completed; Phase 3

Conditions: Congenital Cystic Adenomatoid Malformation

Treatments: Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT00286143

2004-10-3988

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 1 patient group

A

Active Comparator group

Description:

Fentanyl added to Bupivacaine via epidural catheter.

Treatment:

Drug: Fentanyl