Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bupivacaine | Active Comparator | test solution consists of bupivacaine 0.125% |
|
| bupivacaine+epinephrine | Active Comparator | test solution consists of bupivacaine 0.125% with epinephrine 1:200000 |
|
| epinephrine | Active Comparator | test solution consists of epinephrine 1:200000 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous injection of test solution | Drug | test dose consists of 0.2 ml/kg body weight test solution of the assigned drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Markus Weiss, Prof | University Childrens Hospital Zurich, Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Children's Hospital, Anesthesiology | Zurich | 8032 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19915187 | Result | 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 pigs. Br J Anaesth. 2010 Jan;104(1):94-7. doi: 10.1093/bja/aep313. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| intravenous injection of test solution | Drug | test dose consists of 0.2 ml/kg body weight test solution of the assigned drug |
|
| intravenous injection of test solution | Drug | test dose consists of 0.2 ml/kg body weight test solution of the assigned drug |
|
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided