Effects of Additional Fentanyl to Epidural Bupivacaine for Post-Thoracotomy Pain in Neonates
Information source: Children's Hospital of Philadelphia
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Congenital Cystic Adenomatoid Malformation
Intervention: Fentanyl (Drug)
Phase: Phase 3
Sponsored by: Children's Hospital of Philadelphia
Official(s) and/or principal investigator(s):
Arjunan Ganesh, MD, Principal Investigator, Affiliation: Children's Hospital of Philadelphia
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.
Official title: Evaluation of Effects of Additional Fentanyl to Epidural Bupivacaine for Post-Thoracotomy Pain in Neonates on Perioperative Outcome
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: 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).
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.
Minimum age: N/A.
Maximum age: 6 Months.
1. Infants 0-6 months of age who require a thoracotomy for lung resection.
2. Parents accept the placement of an epidural catheter.
1. Premature infants
2. Patients allergic to fentanyl and/or bupivacaine.
3. Known medical contraindications. -
Locations and Contacts
The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States
Starting date: February 2005
Ending date: December 2007
Last updated: December 19, 2007