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

University of Zurich (UZH)

Status and phase: Completed; Phase 4

Conditions: Anaesthesia; Toxicity

Treatments: Drug: intravenous injection of test solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01091766

StV 25/09

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 1 day to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 0 to 16
• healthy
• parental consent

Exclusion criteria

• ASA >1
• allergy against local anaesthetics

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

bupivacaine

Active Comparator group

Description:

test solution consists of bupivacaine 0.125%

Treatment:

Drug: intravenous injection of test solution

Drug: intravenous injection of test solution

Drug: intravenous injection of test solution

bupivacaine+epinephrine

Active Comparator group

Description:

test solution consists of bupivacaine 0.125% with epinephrine 1:200000

Treatment:

Drug: intravenous injection of test solution

Drug: intravenous injection of test solution

Drug: intravenous injection of test solution

epinephrine

Active Comparator group

Description:

test solution consists of epinephrine 1:200000

Treatment:

Drug: intravenous injection of test solution

Drug: intravenous injection of test solution

Drug: intravenous injection of test solution