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

NCT ID: NCT00213239

Last Updated: 2019-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2008-01-31

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.

Conditions

Hematologic Diseases; Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Propofol 4 mg/kg group

First patient in this arm will receive a bolus of propofol 4 mg/kg followed by remifentanil 0.5 mcg/kg. Subsequent patients randomized to this arm will receive propofol 4 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient)

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: DRUG

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.

Propofol 2 mg/kg group

First patient in this arm will receive a bolus of propofol 2 mg/kg followed by remifentanil 1 mcg/kg. Subsequent patients randomized to this arm will receive propofol 2 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient)

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Jason Hayes

Staff Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Hayes, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 18813039 (View on PubMed)

Related Links

http://anesthesiology.pubs.asahq.org/article.aspx?articleid=1922581&resultClick=3

Published October 2008

Other Identifiers

1000007479

Identifier Type: -

Identifier Source: org_study_id