A Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures 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: Hematologic Diseases; Neoplasms
Intervention: Remifentanil (Drug); Remifentanil (Drug)
Phase: Phase 1/Phase 2
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
This study will examine whether the combination of two anaesthetic medications, propofol and
remifentanil, is suitable for short duration surgical procedures, providing a shorter
recovery time and fewer side effects than either drug used alone.
Clinical Details
Official title: The Minimum Effective Dose of Remifentanil When co-Administered With Propofol for Lumbar Puncture in Children: A Dose-Finding Study
Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Movement in response to lumbar puncture needle insertion
Secondary outcome: Incidence of adverse events.Clinically significant changes in heart rate, blood pressure, and oxygen saturation.
Detailed description:
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.
Eligibility
Minimum age: 4 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical diagnosis of a hemato-oncological disorder
- Scheduled to undergo a lumbar puncture
- Aged 4-11 years
- Male or female
- Unpremedicated
- Willing and able to provide informed consent (or informed consent by parents)
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: September 2005
Ending date: January 2008
Last updated: May 29, 2008
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