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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jason Hayes, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00213239
First received: September 13, 2005
Last updated: August 19, 2013
Last verified: August 2013

September 13, 2005
August 19, 2013
September 2005
September 2007   (final data collection date for primary outcome measure)
Movement in response to lumbar puncture needle insertion [ Time Frame: Followed for the length of the procedure. ] [ Designated as safety issue: No ]
- Movement in response to lumbar puncture needle insertion
Complete list of historical versions of study NCT00213239 on ClinicalTrials.gov Archive Site
  • Incidence of adverse events. [ Time Frame: Followed for the length of the procedure. ] [ Designated as safety issue: Yes ]
  • Clinically significant changes in heart rate, blood pressure, and oxygen saturation. [ Time Frame: Followed for the length of the procedure. ] [ Designated as safety issue: No ]
  • - incidence of adverse events
  • - clinically significant changes in heart rate, blood pressure, and oxygen saturation
Not Provided
Not Provided
 
A Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures in Children
The Minimum Effective Dose of Remifentanil When Co-administered With Propofol for Lumbar Puncture in Children: A Dose-finding Study

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Hematologic Diseases
  • Neoplasms
  • 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.
  • 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.
  • Experimental: 1
    Intervention: Drug: Remifentanil
  • Experimental: 2
    Intervention: Drug: Remifentanil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
January 2008
September 2007   (final data collection date for primary outcome measure)

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
Both
4 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00213239
1000007479
No
Jason Hayes, The Hospital for Sick Children
The Hospital for Sick Children
Not Provided
Principal Investigator: Jason Hayes, MD The Hospital for Sick Children, Toronto Canada
The Hospital for Sick Children
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP