A Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures in Children

Neoplasms Clinical Trial

Official title:

The Minimum Effective Dose of Remifentanil When Co-administered With Propofol for Lumbar Puncture in Children: A Dose-finding Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213239
• Other study ID #: 1000007479
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2005
• Est. completion date: January 2008

Study information

• Verified date: November 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Diseases
• Neoplasms

Intervention

Drug:
• Remifentanil
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.
• Remifentanil
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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion	Minimum effective dose (Dixon methodology) and ED98 required to prevent movement during lumbar puncture needle insertion	Movement measured at the time of lumbar puncture needle insertion.
Secondary	Incidence of Adverse Events.		Followed for the length of the procedure.

External Links

•   Published October 2008