Clinical trial NCT00213239: A Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures in Children
Official title: The Minimum Effective Dose of Remifentanil When Co-administered With Propofol for Lumbar Puncture in Children: A Dose-finding Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hematologic Diseases
Neoplasms
Keywords: spinal puncture
remifentanil
propofol
anesthesia
dose finding
pediatrics
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 64
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion
timeFrame: Movement measured at the time of lumbar puncture needle insertion.
Secondary outcomes:
measure: Incidence of Adverse Events.
timeFrame: Followed for the length of the procedure.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Jason Hayes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hayes JA, Lopez AV, Pehora CM, Robertson JM, Abla O, Crawford MW. Coadministration of propofol and remifentanil for lumbar puncture in children: dose-response and an evaluation of two dose combinations. Anesthesiology. 2008 Oct;109(4):613-8. doi: 10.1097/ALN.0b013e31818629f3.