Safe Administration of Propofol for Sedation in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00832013
Recruitment Status : Completed
First Posted : January 29, 2009
Last Update Posted : August 18, 2009
Canadian Anesthesiologists' Society
Information provided by:
University of British Columbia

Brief Summary:

Advances in health care require that more children are given sedation to allow doctors to perform investigations or minor procedures. Sedation drugs have traditionally been given orally (swallowed) by children. However, oral sedation drugs have unpredictable characteristics, such as duration of sedation, which may result in difficulties performing the planned procedure.

Anesthetic drugs are now invariably used for sedation in children. These are given through an IV (skinny plastic tube inserted in to a vein). Propofol (white liquid) is the anesthetic drug most commonly used for sedation at BC Children's Hospital for sedation. Propofol has several advantages, including an accurately controllable depth of sedation (how deeply asleep), minimal effect on the heart and circulation and control of reflexes (e,g coughing) during the procedure. Propofol also promotes rapid recovery with less sickness and an earlier return to normal functioning following the procedure.

While propofol has many advantages it can cause respiratory depression (reduced breathing rate). This reduction in breathing is more common if propofol is given quickly. When your child is given propofol for their proposed procedure this is performed by a pediatric anesthesiologist who is skilled in supporting breathing should this be required. If your child does not participate in this study they will still receive propofol administered by the anesthesiologist as this is our usual practice. It would be routine to administer the propofol rapidly and then support breathing for a few minutes. This is very safe in the hands of an expert anesthesiologist but can be sometimes more risky in other settings where extensive monitoring and anesthesiologists are not available. This is the setting that propofol is used in many institutions.

Our goal is to determine how quickly propofol can be given without reducing breathing to the point that help with breathing is required.

Condition or disease Intervention/treatment Phase
Sedation Drug: Propofol Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safe Administration of Propofol for Sedation in Children
Study Start Date : June 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
Active Comparator: 1

Propofol 1 % at a dose of 4mg/kg will be administered intravenously via a standard Medex Protégé® 3010 (Medex-A Furon. Healthcare Company, Duluth, GA, USA) infusion pump at a constant rate determined by the randomization schedule. Fresh gas flow will be maintained at 6 l/min throughout the induction procedure with the FiO2 increased to 0.5. Full cardiovascular, respiratory and EEG monitoring will continue during induction of anesthesia.

Once the loading dose of propofol has been delivered the propofol infusion will be maintained at a rate of 200mcg/kg/min or as determined by the attending anesthesiologist whilst the end-point respiratory responses are observed.

Drug: Propofol
See detailed description

Active Comparator: 2
Same procedure as above. These subjects will be stratified by age and randomized, using the Biased Coin Design (BCD) principle to determine the infusion rate of propofol for delivery of the induction dose.
Drug: Propofol
See detailed description

Primary Outcome Measures :
  1. Positive result: Spontaneous ventilation continues following administration of the full loading dose of propofol by infusion. [ Time Frame: Before and during surgery ]

Secondary Outcome Measures :
  1. Negative result: Apnoea occurs (no breath for 20 seconds or oxygen saturation less than 90%) before the complete dose is administered or within 4 minutes of the end of the dose. [ Time Frame: Before and during surgery ]

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

All ASA category 1 and 2 children aged 6-15y for elective upper or lower gastrointestinal endoscopic investigations to be performed under sedation. Stratification by age (<9y, 9-12y, >12y) will be performed to ensure balanced allocation of age groups and allow for identification of age and weight specific effects.

Exclusion Criteria:

  • Subjects with a history or signs of chronic lung disease;
  • Active upper respiratory tract infection;
  • Chronic opioid or other sedative drug therapy;
  • Anticipated difficult airway, reflux, delayed gastric emptying;
  • Other indications for endotracheal intubation;
  • Subjects outwith the 5th or 95th centile of weight for age: translates to a minimum weight of 12kg at 3 years and maximum of 79kg at 15y.
  • Contra-indications to propofol or lidocaine.

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 identifier (NCT number): NCT00832013

Canada, British Columbia
BC Children's Hospital, Department of Anesthesia
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Canadian Anesthesiologists' Society
Principal Investigator: Mark Ansermino, MD University of British Columbia
Study Director: Jon McCormack University of British Columbia
Study Director: Eleanor Reimer University of British Columbia
Study Director: Guy Dumont University of British Columbia
Study Director: Prasad Shrawane University of British Columbia
Study Director: Rollin Brant University of British Columbia

Responsible Party: Dr. Mark Ansermino, University of British Columbia Identifier: NCT00832013     History of Changes
Other Study ID Numbers: H07-02846
First Posted: January 29, 2009    Key Record Dates
Last Update Posted: August 18, 2009
Last Verified: August 2009

Keywords provided by University of British Columbia:
Induction of sedation

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General