34 patients aged between 0 and 3 months parted into 2 groups have to undergo caudal block. Group 1 receive a block with 1ml/kg Naropin 3.75% Group 2 receive a block with 1ml/kg Naropin 3.75% and additional 5mg/kg/h propofol 10mg/ml To evaluate the level of sedation we use the Comfort-B Scale, (a sedation score for children)and the change of heart rate throughout the study period as an expression of the actual sedation and stress
Conditions
Interventions
Trade Name: Propofol ratiopharm 10mg/ml
Product Name: Propofol
Product Code: 1–30747
Pharmaceutical Form: Emulsion for injection/infusion
INN or Proposed INN: Propofol
CAS Number: 2078-54-8
Current
Sponsors
Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Infants aged between 0 and 3 months (inclusive preterm) • Lower body surgery with planned caudal blockade • Written informed consent given by parents after being provided with detailed information about the nature, risks, and scope of the clinical study • No legal incapacity and/or other circumstances rendering the parents unable to understand the nature, scope and possible consequences of the study Are the trial subjects under 18? yes Number of subjects for this age range: 34 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Parents refusal • Contraindications against a caudal blockade • Coagulopathy in the patients history • Other objections to participate in the study in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Pediatric patients (between 0 and 3 months) do not need further medication for sedation after caudal block;Secondary Objective: There is no change in intra- and postoperative level of sedation and heart rate ;Primary end point(s): After caudal block children do not need further medication for surgery. ;Timepoint(s) of evaluation of this end point: The level of sedation will be evaluated every 10 minutes using the Comfort B-Scale and the percentage of change of the HR will be recorded. These measurements will be continued during the first two postoperative hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No change of heart rate and sedation without additional medication for sedation;Timepoint(s) of evaluation of this end point: The level of sedation will be evaluated every 10 minutes using the Comfort B-Scale and the percentage of change of the HR will be recorded. These measurements will be continued during the first two postoperative hours. | — |
Countries
Austria
Contacts
Public ContactDaniela Marhofer
Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
Outcome results
None listed