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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00286143
Recruitment Status : Completed
First Posted : February 3, 2006
Last Update Posted : September 16, 2009
Information provided by:
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Congenital Cystic Adenomatoid Malformation Drug: Fentanyl Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Effects of Additional Fentanyl to Epidural Bupivacaine for Post-Thoracotomy Pain in Neonates on Perioperative Outcome
Study Start Date : February 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

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 Name: Actiq®; Duragesic®; Fentora™; Ionsys™; Sublimaze®

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00286143

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United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
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Principal Investigator: Arjunan Ganesh, MD Children's Hospital of Philadelphia
Publications of Results:
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Responsible Party: Arjunan Ganesh, MBBS, Children's Anesthesiology Associates Identifier: NCT00286143    
Other Study ID Numbers: 2004-10-3988
First Posted: February 3, 2006    Key Record Dates
Last Update Posted: September 16, 2009
Last Verified: September 2009
Additional relevant MeSH terms:
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Cystic Adenomatoid Malformation of Lung, Congenital
Congenital Abnormalities
Lung Diseases
Respiratory Tract Diseases
Respiratory System Abnormalities
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General