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. |
| ClinicalTrials.gov Identifier: NCT00286143 |
|
Recruitment Status :
Completed
First Posted : February 3, 2006
Last Update Posted : September 16, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Congenital Cystic Adenomatoid Malformation | Drug: Fentanyl | Phase 3 |
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.
| 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® |
- 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 ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | up to 6 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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. -
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 ClinicalTrials.gov identifier (NCT number): NCT00286143
| 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: | Arjunan Ganesh, MBBS, Children's Anesthesiology Associates |
| ClinicalTrials.gov 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 |
|
Cystic Adenomatoid Malformation of Lung, Congenital Congenital Abnormalities Lung Diseases Respiratory Tract Diseases Respiratory System Abnormalities Fentanyl Analgesics, Opioid Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics |