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OpenTrials
Completed

NCT Number: NCT00213239

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

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.

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Key information

Age range

4 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

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.

Primary outcomes

  1. Dose of Remifentanil Required to Prevent Movement in Response to Lumbar Puncture Needle Insertion

    Time frame: Movement measured at the time of lumbar puncture needle insertion.

    Minimum effective dose (Dixon methodology) and ED98 required to prevent movement during lumbar puncture needle insertion

Secondary outcomes

  1. Incidence of Adverse Events.

    Time frame: Followed for the length of the procedure.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Sep 21, 2005
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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