N47
Conditions
Interventions
Group 1: The study is descriptive and we plan to include 80 consecutive children scheduled for circumcision, in this study. 20 children per age stratum from 0-2 years (incl. former preterms), from 3 t
Sponsors
Medizinische Universität Wien
Eligibility
Sex/Gender
Male
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: Children are included if scheduled for circumcision. Parents have undersigned the written informed consent after being informed in detail about the nature, risks, and scope of the clinical study and any expected desirable and potentially adverse effects. Neither legally incapacitated nor subject to any other circumstances rendering the parents unable to understand the nature, scope, and possible consequences of the study
Exclusion criteria
Exclusion criteria: Parent's refusal of participation of their child in the study and exclusion criteria are contraindication against epidural anaesthesia - Neurological disorders - Coagulation disorders - Thrombocytopenia - Allergy against amino-amide local anaesthetics - Local infection on the intended injection site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint will be success rate of surgical blockade, meaning that the surgical procedure will be performed without induction of general anaesthesia. Blockade is de?ned as successful if the skin incision 15 minutes after blockade does not evoke movement of the child and if the hemodynamics remain stable during the surgical procedure. If the heart rate increases by more than 20% from baseline before blockade or if other evident signs of pain like tachypnea or any kind of unintentional movements are noted, a “rescue-bolus” of fentanyl 1 µg x kg-1 and, if needed, propofol will be administered. Failure is assumed if despite the “rescue –bolus” of fentanyl sings of pain are evident and induction of general anaesthesia is necessary. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints will include the amount of additional analgesic drugs during and after the surgical procedure and the rate of general anaesthesias needed to perform the surgical procedure. | — |
Countries
Austria
Contacts
Public ContactWerner Schmid
Medizinische Universität Wien
Outcome results
None listed