Safe Administration of Propofol for Sedation in Children

This study has been completed.
Sponsor:
Collaborator:
Canadian Anesthesiologists' Society
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00832013
First received: January 27, 2009
Last updated: August 17, 2009
Last verified: August 2009
  Purpose

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 Intervention
Sedation
Drug: Propofol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safe Administration of Propofol for Sedation in Children

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

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

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832013

Locations
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
Investigators
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
  More Information

No publications provided

Responsible Party: Dr. Mark Ansermino, University of British Columbia
ClinicalTrials.gov Identifier: NCT00832013     History of Changes
Other Study ID Numbers: H07-02846
Study First Received: January 27, 2009
Last Updated: August 17, 2009
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Propofol
sedation
pediatric
Induction of sedation

Additional relevant MeSH terms:
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on July 31, 2014