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

Anaesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091766
• Other study ID #: StV 25/09
• Status: Completed
• Phase: Phase 4
• First received: March 22, 2010
• Last updated: July 23, 2012
• Start date: March 2010
• Est. completion date: July 2011

Study information

• Verified date: July 2012
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

• Age 0 to 16

• healthy

• parental consent

Exclusion Criteria:

• ASA >1

• allergy against local anaesthetics

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anaesthesia
• Toxicity

Intervention

Drug:
• intravenous injection of test solution
test dose consists of 0.2 ml/kg body weight test solution of the assigned drug
• intravenous injection of test solution
test dose consists of 0.2 ml/kg body weight test solution of the assigned drug
• intravenous injection of test solution
test dose consists of 0.2 ml/kg body weight test solution of the assigned drug

Locations

Country	Name	City	State
Switzerland	University Children's Hospital, Anesthesiology	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Mauch J, Kutter AP, Madjdpour C, Koepfer N, Frotzler A, Bettschart-Wolfensberger R, Weiss M. Electrocardiographic alterations during intravascular application of three different test doses of bupivacaine and epinephrine: experimental study in neonatal pig — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes