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Sponsored by: |
Children's Hospital of Philadelphia |
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Information provided by: | Children's Hospital of Philadelphia |
ClinicalTrials.gov Identifier: | NCT00286143 |
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 | Intervention | Phase |
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Congenital Cystic Adenomatoid Malformation |
Drug: Fentanyl |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of Effects of Additional Fentanyl to Epidural Bupivacaine for Post-Thoracotomy Pain in Neonates on Perioperative Outcome |
Enrollment: | 32 |
Study Start Date: | February 2005 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Fentanyl added to Bupivacaine via epidural catheter.
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Drug: Fentanyl
Fentanyl is added to epidural Bupivacaine to be administered to neonates having thoracotomy for lung resections.
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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:
Ages Eligible for Study: | up to 6 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
The Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Arjunan Ganesh, MD | Children's Hospital of Philadelphia |
Responsible Party: | Children's Anesthesiology Associates ( Arjunan Ganesh, MBBS ) |
Study ID Numbers: | 2004-10-3988 |
Study First Received: | February 1, 2006 |
Last Updated: | July 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00286143 |
Health Authority: | United States: Institutional Review Board |
Fentanyl Respiratory Tract Diseases Lung Diseases Bupivacaine |
Pain Cystic Adenomatoid Malformation of Lung, Congenital Congenital Abnormalities Cystic adenomatoid malformation of lung |
Anesthetics, Intravenous Respiratory System Abnormalities Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Narcotics Anesthetics, Local Pharmacologic Actions |
Adjuvants, Anesthesia Anesthetics, General Sensory System Agents Therapeutic Uses Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid |