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

University Children's Hospital, Zurich150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

150

Conditions

Anaesthesia Toxicity

Interventions

intravenous injection of test solutionDRUG

test dose consists of 0.2 ml/kg body weight test solution of the assigned drug

intravenous injection of test solutionDRUG

test dose consists of 0.2 ml/kg body weight test solution of the assigned drug

intravenous injection of test solutionDRUG

test dose consists of 0.2 ml/kg body weight test solution of the assigned drug

Eligibility

Sex: ALLMin age: 1 DayMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Children's Hospital, Anesthesiology

Zurich, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: 2 minutes

Secondary Outcomes

Alteration in heart rate caused by intravenous injection of the test solution

Time frame: 2 minutes

Data from ClinicalTrials.gov

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