Status:
COMPLETED
Safe Administration of Propofol for Sedation in Children
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Canadian Anesthesiologists' Society
Conditions:
Sedation
Eligibility:
All Genders
6-15 years
Phase:
NA
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...
Detailed Description
Purpose Advances in minimally invasive radiological and surgical techniques demand that increasing numbers of children are given sedation or anesthesia to facilitate these procedures, frequently perfo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00832013
Start Date
June 1 2008
End Date
August 1 2009
Last Update
August 18 2009
Active Locations (1)
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1
BC Children's Hospital, Department of Anesthesia
Vancouver, British Columbia, Canada, V6H 3V4