Co-Administration of Propofol and Remifentanil for Lumbar Puncture in Children
Information source: The Hospital for Sick Children
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spinal Puncture
Intervention: Propofol + Remifentanil (Drug); Propofol + Remifentanil (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: The Hospital for Sick Children Official(s) and/or principal investigator(s):
Jason Hayes, MD, Principal Investigator, Affiliation: The Hospital for Sick Children, Toronto Canada
Summary
The objective of this study is to compare intraoperative and recovery parameters in patients
who receive two different dose combinations of propofol and remifentanil in patients
undergoing a lumbar puncture.
Clinical Details
Official title: Co-Administration of Propofol and Remifentanil for Lumbar Puncture in Children: Evaluation of Two Dose Combinations
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study
Primary outcome: Intraoperative parameters (duration of apnea, episodes of bradycardia or hypotension, heart rate, blood pressure, and oxygen saturation).Duration of postoperative recovery (time to spontaneous eye opening, verbalization, purposeful movement).
Secondary outcome: Incidence of adverse events and clinically significant changes in routine vital signs as measured by electrocardiogram, non-invasive blood pressure, and pulse oximeter.
Detailed description:
Lumbar punctures (LP) are performed in approximately one thousand oncology patients per year
at the Hospital for Sick Children. In a previous study, we determined the optimal dose of
remifentanil which provides effective anesthesia with little or no movement during LP in
children. The present study will determine the optimal dose combination of propofol and
remifentanil to keep patients comfortable and still during the procedure while decreasing the
incidence of side effects and allows for shorter recovery times and earlier discharge from
the recovery room.
Eligibility
Minimum age: 3 Years.
Maximum age: 12 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical diagnosis of a hemato-oncological disorder
- Scheduled to undergo a lumbar puncture
- Aged 3-12 years
- Unpremedicated
Exclusion Criteria:
- children who are known or suspected to be difficult to ventilate by face mask
- children who are deemed medically unfit to receive either of the two study
medications
- children who are obese (weight for height > 95th percentile)
- children who do not have an indwelling intravenous line
Locations and Contacts
The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada
Additional Information
Starting date: November 2006
Ending date: June 2007
Last updated: May 27, 2008
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