Sensitivity of ECG on Detection of Three Different Intravascular Applied Test Doses of Bupivacaine and Epinephrine

Study Overview
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Brief Summary
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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.

Official Title
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Sensitivity of Electrocardiogram on Detection of Three Different Intravascular Applied Test Doses of Bupivacaine and Epinephrine: a Study in Children of Different Age

Conditions
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Anaesthesia, Toxicity

Intervention / Treatment
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* Drug: intravenous injection of test solution
* Drug: intravenous injection of test solution
* Drug: intravenous injection of test solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 0 to 16 healthy parental consent Exclusion Criteria: ASA >1 allergy against local anaesthetics

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bupivacaine<br>test solution consists of bupivacaine 0.125% | Drug: intravenous injection of test solution<br>* test dose consists of 0.2 ml/kg body weight test solution of the assigned drug<br>|
| Active Comparator: bupivacaine+epinephrine<br>test solution consists of bupivacaine 0.125% with epinephrine 1:200000 | Drug: intravenous injection of test solution<br>* test dose consists of 0.2 ml/kg body weight test solution of the assigned drug<br>|
| Active Comparator: epinephrine<br>test solution consists of epinephrine 1:200000 | Drug: intravenous injection of test solution<br>* test dose consists of 0.2 ml/kg body weight test solution of the assigned drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-wave elevation in the ECG after intravenous administration of the test solution | 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. | 2 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alteration in heart rate caused by intravenous injection of the test solution | 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 in heart rate. | 2 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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local anaesthetics toxicity, heart arrhythmia, heart rate, heart conduction, regional anaesthesia, paediatric anaesthesia, cardio-vascular system, prevention