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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01091766

Enrollment

150

Registered

2010-03-24

Start date

2010-03-31

Completion date

2011-07-31

Last updated

2012-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthesia, Toxicity

Keywords

local anaesthetics toxicity, heart arrhythmia, heart rate, heart conduction, regional anaesthesia, paediatric anaesthesia, cardio-vascular system, prevention

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.

Interventions

DRUGintravenous injection of test solution

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 16 Years

Healthy volunteers

Yes

Inclusion criteria

* Age 0 to 16 * healthy * parental consent

Exclusion criteria

* ASA \>1 * allergy against local anaesthetics

Design outcomes

Primary

Measure	Time frame	Description
T-wave elevation in the ECG after intravenous administration of the test solution	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

Measure	Time frame	Description
Alteration in heart rate caused by intravenous injection of the test solution	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 in heart rate.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026