Co-Administration of Propofol and Remifentanil for Lumbar Puncture in Children - Full Text View

Sponsor:	The Hospital for Sick Children
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00405522

Purpose

The objective of this study is to compare intraoperative and recovery parameters in patients who receive two different dose combinations of propofol and remifentanil in patients undergoing a lumbar puncture.

Condition	Intervention	Phase
Spinal Puncture	Drug: Propofol + Remifentanil	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Co-Administration of Propofol and Remifentanil for Lumbar Puncture in Children: Evaluation of Two Dose Combinations

Resource links provided by NLM:

Drug Information available for: Remifentanil hydrochloride Remifentanil Propofol

U.S. FDA Resources

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

Primary Outcome Measures:

Intraoperative parameters (duration of apnea, episodes of bradycardia or hypotension, heart rate, blood pressure, and oxygen saturation). [ Time Frame: Followed for the length of the procedure. ] [ Designated as safety issue: No ]
Duration of postoperative recovery (time to spontaneous eye opening, verbalization, purposeful movement). [ Time Frame: Time frame determined by outcome; followed for length of the procedure. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of adverse events and clinically significant changes in routine vital signs as measured by electrocardiogram, non-invasive blood pressure, and pulse oximeter. [ Time Frame: Followed for the length of the procedure. ] [ Designated as safety issue: Yes ]

Enrollment:	34
Study Start Date:	November 2006
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Propofol + Remifentanil Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
2: Experimental	Drug: Propofol + Remifentanil Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.

Detailed Description:

Lumbar punctures (LP) are performed in approximately one thousand oncology patients per year at the Hospital for Sick Children. In a previous study, we determined the optimal dose of remifentanil which provides effective anesthesia with little or no movement during LP in children. The present study will determine the optimal dose combination of propofol and remifentanil to keep patients comfortable and still during the procedure while decreasing the incidence of side effects and allows for shorter recovery times and earlier discharge from the recovery room.

Eligibility

Ages Eligible for Study:	3 Years to 12 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 3-12 years
Unpremedicated

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: NCT00405522

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:	1000009427
Study First Received:	November 28, 2006
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00405522 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by The Hospital for Sick Children:

Lumbar Puncture
Pediatrics
Propofol

Remifentanil
sedation
Oncology

Additional relevant MeSH terms:

Anesthetics, Intravenous
Remifentanil
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pharmacologic Actions
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 November 25, 2009