Safe Administration of Propofol for Sedation in Children

NCT00832013 | Completed

• 1 other identifier: H07-02846
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation

Keywords

Propofol; sedation; pediatric; Induction of sedation

Outcome Measures

Primary Outcomes (1)

• Positive result: Spontaneous ventilation continues following administration of the full loading dose of propofol by infusion.

  Before and during surgery

Secondary Outcomes (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.

  Before and during surgery

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

ACTIVE COMPARATOR

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

Interventions

Propofol DRUG

See detailed description

1

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Anesthesiologists' Society: collaborator

Study Sites (1)

BC Children's Hospital, Department of Anesthesia

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Mark Ansermino, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 29, 2009
• Study Start: June 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 18, 2009

Record last verified: 2009-08

Locations

CA (1)