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Completed

NCT Number: NCT00286143

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

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.

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Key information

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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:

  • bupivacaine 0.1%
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants 0-6 months of age who require a thoracotomy for lung resection.
  • Parents accept the placement of an epidural catheter.

Exclusion criteria

  • Premature infants
  • Patients allergic to fentanyl and/or bupivacaine.
  • Known medical contraindications. -

Treatment and study plan

Fentanyl

Drug

Fentanyl is added to epidural Bupivacaine to be administered to neonates having thoracotomy for lung resections.

Other names: Actiq®; Duragesic®; Fentora™; Ionsys™; Sublimaze®

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

Evaluation of Effects of Additional Fentanyl to Epidural Bupivacaine for Post-Thoracotomy Pain in Neonates on Perioperative Outcome

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Feb 3, 2006
Registry last updated
Sep 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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