Status:
COMPLETED
A Pilot Study to Investigate Plasma Bupivacaine Concentrations in Children Receiving Total Intravenous Anaesthesia and Caudal Analgesia
Lead Sponsor:
University of British Columbia
Conditions:
Anesthesia
Eligibility:
All Genders
6-5 years
Phase:
PHASE1
PHASE2
Brief Summary
The objective of this pilot study is to compare plasma \[bupivacaine\] between two groups of paediatric patients under general anaesthesia who will all receive regional caudal anaesthesia with bupivac...
Detailed Description
Hypothesis: The investigators hypothesize that there will be a detectable difference in free plasma \[bupivacaine\] between these two treatment groups, with lower free plasma \[bupivacaine\] in the T...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age 6 months - 5 years
- ASA I-II
- Undergoing elective day surgery for which combined general and caudal epidural anaesthesia is indicated
- Written parental/guardian informed consent
- Exclusion criteria:
- Weight and body mass index \< 3rd or \> 97th percentile for age
- Any contraindication to caudal injection
- Renal, hepatic, neuromuscular or cardiac disease
- Acute inflammatory process or infectious processes that provoke an acute phase response, ongoing or resolved less than 2 weeks prior to recruitment day (such as recent surgery, respiratory tract infection (including colds), urinary tract infection, infectious or inflammatory gastroenteritis, otitis media, skin or wound infection, cholecystitis, pancreatitis, hepatitis, meningitis) Chronic co-existing inflammatory diseases (eg, inflammatory bowel disease, juvenile arthritis, cystic fibrosis, autoimmune disease, connective tissue disease, chronic liver disease)
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01216007
Start Date
October 1 2010
End Date
October 1 2012
Last Update
June 26 2017
Active Locations (1)
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1
BC Children's Hospital, Department of Anesthesia
Vancouver, British Columbia, Canada, V6H 3V4