Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187135
Status:
TERMINATED
Last Update Posted:
2017-04-04
First Post:
2005-09-12
Brief Title:
Study of Fentanyl-Propofol-EMLA of LMX4 Technique for Bone Marrow Aspiration
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Fentanyl-Propofol-EMLA or LMX4 Technique for Bone Marrow Aspiration in Pediatric Patients - A Phase III Study
Status:
TERMINATED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
St Jude Childrens Research Hospital is studying the best ways to prevent pain during and after procedures such as bone marrow aspiration and lumbar puncture with intrathecal in the spinal fluid chemotherapy Researchers will study the effectiveness of combining anesthetics medicines that help people sleep and analgesics medicines that relieve pain Researchers believe that a combination of fentanyl analgesic and propofol anesthetic along with applying the skin-numbing-cream EMLA or LMX4 on the area where the procedure is performed will provide better pain control
Each patient enrolled on this study will have three different anesthetic combinations for three different procedures in order to determine which combination worked best for each child
Each patient enrolled on this study will have three different anesthetic combinations for three different procedures in order to determine which combination worked best for each child
Detailed Description:
The study focusses on the following primary aims
To compare 05 mgkg versus 10 mgkg of fentanyl to control pain in patients who have a BMTLPIT procedure in the context of propofol anesthesia and topical anesthesia with EMLA or LMX 4cream or when necessary lidocaine for injection
To compare placebo versus fentanyl 05 mgkg or 10 mgkg in these same patients The first BMTLPIT for which patients receive any fentanyl will be used in this comparison
The study focusses on the following secondary aims
To determine which dose regimen ensures best conditions to perform bone marrow aspiration lack of motion and maintains hemodynamic and respiratory stability as indicators of adequate levels of analgesia during bone marrow aspiration
To evaluate the safety and complications for each dose regimen
To compare 05 mgkg versus 10 mgkg of fentanyl to control pain in patients who have a BMTLPIT procedure in the context of propofol anesthesia and topical anesthesia with EMLA or LMX 4cream or when necessary lidocaine for injection
To compare placebo versus fentanyl 05 mgkg or 10 mgkg in these same patients The first BMTLPIT for which patients receive any fentanyl will be used in this comparison
The study focusses on the following secondary aims
To determine which dose regimen ensures best conditions to perform bone marrow aspiration lack of motion and maintains hemodynamic and respiratory stability as indicators of adequate levels of analgesia during bone marrow aspiration
To evaluate the safety and complications for each dose regimen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None