Sensitivity of Electrocardiogram on Detection of Three Different Intravascular Applied Test Doses of Bupivacaine and Epinephrine: a Study in Children of Different Age
Overview
- Phase
- Phase 4
- Intervention
- intravenous injection of test solution
- Conditions
- Anaesthesia
- Sponsor
- University Children's Hospital, Zurich
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- T-wave elevation in the ECG after intravenous administration of the test solution
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this prospective randomised study is to investigate electrocardiographic alterations after intravascular injection of three different test solutions of bupivacaine and epinephrine in anaesthetised children up to 16 years of age.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 0 to 16
- •parental consent
Exclusion Criteria
- •allergy against local anaesthetics
Arms & Interventions
bupivacaine
test solution consists of bupivacaine 0.125%
Intervention: intravenous injection of test solution
bupivacaine+epinephrine
test solution consists of bupivacaine 0.125% with epinephrine 1:200000
Intervention: intravenous injection of test solution
epinephrine
test solution consists of epinephrine 1:200000
Intervention: intravenous injection of test solution
Outcomes
Primary Outcomes
T-wave elevation in the ECG after intravenous administration of the test solution
Time Frame: 2 minutes
0.2 ml/kg test solution (bupivacaine or bupivacaine+epinephrine or epinephrine) is intravenously injected. The ECG is recorded over 2 minutes, printed and analysed later on regarding alterations of T-wave.
Secondary Outcomes
- Alteration in heart rate caused by intravenous injection of the test solution(2 minutes)