A Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures in Children - Full Text View

Sponsored by:	The Hospital for Sick Children
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00213239

Purpose

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	Intervention	Phase
Hematologic Diseases Neoplasms	Drug: Remifentanil	Phase I Phase II

MedlinePlus related topics: Anesthesia Cancer

Drug Information available for: Remifentanil hydrochloride Remifentanil Propofol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Minimum Effective Dose of Remifentanil When co-Administered With Propofol for Lumbar Puncture in Children: A Dose-Finding Study

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:

Movement in response to lumbar puncture needle insertion [ Time Frame: Followed for the length of the procedure. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	64
Study Start Date:	September 2005
Study Completion Date:	January 2008
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.
2: Experimental	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.

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.

Eligibility

Ages Eligible for Study:	4 Years to 11 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Responsible Party:	The Hospital for Sick Children ( Jason Hayes/Principal Investigator )
Study ID Numbers:	1000007479
Study First Received:	September 13, 2005
Last Updated:	May 29, 2008
ClinicalTrials.gov Identifier:	NCT00213239 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by The Hospital for Sick Children:

spinal puncture
remifentanil
propofol

anesthesia
dose finding
pediatrics

Study placed in the following topic categories:

Anesthetics, Intravenous
Signs and Symptoms
Remifentanil
Anesthetics, General
Hematologic Diseases
Hypnotics and Sedatives

Central Nervous System Depressants
Anesthetics
Peripheral Nervous System Agents
Analgesics
Propofol
Analgesics, Opioid

Additional relevant MeSH terms:

Anesthetics, Intravenous
Remifentanil
Hematologic Diseases
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pharmacologic Actions
Neoplasms
Sensory System Agents

Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Peripheral Nervous System Agents
Analgesics
Propofol
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 07, 2009