A Phase 4 interventional study of intravenous injection of test solution and intravenous injection of test solution in Anaesthesia and Toxicity, sponsored by University Children's Hospital, Zurich. Completed at 1 site in Switzerland. Open to participants aged 1 Day to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-24.
Sponsored by University Children's Hospital, Zurich · Phase 4, Interventional, and Prevention
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.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 150 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →University Children's Hospital, Zurich is the lead sponsor of 92 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
test solution consists of bupivacaine 0.125%
Drug: intravenous injection of test solution
test solution consists of bupivacaine 0.125% with epinephrine 1:200000
Drug: intravenous injection of test solution
test solution consists of epinephrine 1:200000
Drug: intravenous injection of test solution
test dose consists of 0.2 ml/kg body weight test solution of the assigned drug
test dose consists of 0.2 ml/kg body weight test solution of the assigned drug
test dose consists of 0.2 ml/kg body weight test solution of the assigned drug
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
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.
Time frame: 2 minutes
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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University Children's Hospital, Zurich