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

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00286143
First received: February 1, 2006
Last updated: September 14, 2009
Last verified: September 2009

February 1, 2006
September 14, 2009
February 2005
December 2007   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00286143 on ClinicalTrials.gov Archive Site
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 ]
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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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Congenital Cystic Adenomatoid Malformation
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®
Active Comparator: A
Fentanyl added to Bupivacaine via epidural catheter.
Intervention: Drug: Fentanyl
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
December 2007
December 2007   (final data collection date for primary outcome measure)

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. -
Both
up to 6 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00286143
2004-10-3988
No
Arjunan Ganesh, MBBS, Children's Anesthesiology Associates
Children's Hospital of Philadelphia
Not Provided
Principal Investigator: Arjunan Ganesh, MD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP