A Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures in Children
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Minimum Effective Dose of Remifentanil When Co-administered With Propofol for Lumbar Puncture in Children: A Dose-finding Study|
- Movement in response to lumbar puncture needle insertion [ Time Frame: Followed for the length of the procedure. ] [ Designated as safety issue: No ]
- Incidence of adverse events. [ Time Frame: Followed for the length of the procedure. ] [ Designated as safety issue: Yes ]
- Clinically significant changes in heart rate, blood pressure, and oxygen saturation. [ Time Frame: Followed for the length of the procedure. ] [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Study Completion Date:||January 2008|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
Propofol is the primary medication used by anesthesiologists at HSC to provide sedation for lumbar puncture. Propofol provides amnesia, anxiolysis, and hypnosis, but because propofol has no analgestic properties patients often respond to the pain of LP needle insertion. To ensure patient immobility, the dose of propofol is often increased, resulting in a duration of action that is excessive for lumbar puncture. Remifentanil is an ultra-short acting opioid which can be used to provide analgesia and sedation for short painful procedures with minimal residual pain. However, when used as the sole agent, remifentanil is associated with a high incidence of respiratory depression and/or arterial oxygen desaturation and does not provide amnesia or anxiolysis. The combination of propofol and remifentanil may be particularly suitable for short duration procedures, providing a shorter recovery time and fewer side effects than either drug used alone.
The objective is to determine the minimum effective dose of remifentanil required to prevent movement for insertion of a lumbar puncture needle when co-administered with propofol. The results obtained from this study will be used in a future study of the recovery characteristics of propofol and remifentanil in children undergoing lumbar puncture.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213239
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Jason Hayes, MD||The Hospital for Sick Children, Toronto Canada|