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

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ClinicalTrials.gov Identifier: NCT00213239
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : August 20, 2013
Sponsor:
Information provided by (Responsible Party):
Jason Hayes, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Hematologic Diseases Neoplasms Drug: Remifentanil Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Minimum Effective Dose of Remifentanil When Co-administered With Propofol for Lumbar Puncture in Children: A Dose-finding Study
Study Start Date : September 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 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.

Experimental: 2 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.




Primary Outcome Measures :
  1. Movement in response to lumbar puncture needle insertion [ Time Frame: Followed for the length of the procedure. ]

Secondary Outcome Measures :
  1. Incidence of adverse events. [ Time Frame: Followed for the length of the procedure. ]
  2. Clinically significant changes in heart rate, blood pressure, and oxygen saturation. [ Time Frame: Followed for the length of the procedure. ]


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Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00213239


Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Jason Hayes, MD The Hospital for Sick Children, Toronto Canada

Responsible Party: Jason Hayes, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00213239     History of Changes
Other Study ID Numbers: 1000007479
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: August 20, 2013
Last Verified: August 2013

Keywords provided by Jason Hayes, The Hospital for Sick Children:
spinal puncture
remifentanil
propofol
anesthesia
dose finding
pediatrics

Additional relevant MeSH terms:
Hematologic Diseases
Propofol
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents