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The Minimum Effective Dose of Remifentanil When co-Administered With Propofol for Lumbar Puncture in Children: A Dose-Finding Study

Phase 1/Phase 2
4 Years
11 Years
Not Enrolling
Hematologic Diseases, Neoplasms

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Trial Information

The Minimum Effective Dose of Remifentanil When co-Administered With Propofol for Lumbar Puncture in Children: A Dose-Finding Study

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.

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

- Children who are obese (weight for height > 95th percentile,

- Children who do not have an indwelling intravenous line

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Movement in response to lumbar puncture needle insertion

Outcome Time Frame:

Followed for the length of the procedure.

Safety Issue:


Principal Investigator

Jason Hayes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Hospital for Sick Children, Toronto Canada


Canada: Health Canada

Study ID:




Start Date:

September 2005

Completion Date:

January 2008

Related Keywords:

  • Hematologic Diseases
  • Neoplasms
  • spinal puncture
  • remifentanil
  • propofol
  • anesthesia
  • dose finding
  • pediatrics
  • Neoplasms
  • Hematologic Diseases