An analysis of additional medication for sedation in infants who have a regional anaesthesia technique (and no general anaesthesia) for lower body surgery

Phase 1

Conditions: 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/mlTo 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
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2013-002354-72-AT

Lead Sponsor: Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>;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 Outcome Measures

Name	Time	Method
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.