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Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00005059
Date of registration:	01/06/2015
Prospective Registration:	No
Primary sponsor:	Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
Public title:	A quantitative analysis of sedation in infants with caudal blockade
Scientific title:	A quantitative analysis of sedation in infants with caudal blockade - /
Date of first enrolment:	01/10/2013
Target sample size:	34
Recruitment status:	Complete
URL:	http://drks.de/search/en/trial/DRKS00005059
Study type:	interventional
Study design:	Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: treatment
Phase:	N/A

Countries of recruitment
Austria

Contacts

Name:	Wolfgang Klug
Address:	Währinger Gürtel 18-20 1090 Wien Austria
Telephone:	0043 1 19231
Email:	wolfgang.klug@meduniwien.ac.at
Affiliation:	AKH Wien

Name:	Wolfgang Klug
Address:	Währinger Gürtel 18-20 1090 Wien Austria
Telephone:	0043 1 19231
Email:	wolfgang.klug@meduniwien.ac.at
Affiliation:	AKH Wien

Key inclusion & exclusion criteria

Inclusion criteria: - Infants aged between 0 and 3 months
- 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

Exclusion criteria: - Parents refusal
- Contraindications against a caudal blockade
- Coagulopathy

Age minimum: 0 Months
Age maximum: 3 Months
Gender: All

Health Condition(s) or Problem(s) studied

Unilateral or unspecified inguinal hernia, without obstruction or gangrene

K40.9

Intervention(s)

Group 1: Infants who will undergo lower body surgery in caudal anaesthesia, won't get a continuous infusion of propofol.
Group 2: Infants who will undergo lower body surgery in caudal anaesthesia, will get a continuous infusion of propofol in a dosage of 5mg/kg KG/h administered.

Primary Outcome(s)

The main objective of the recent study is to investigate the need of additional anesthetic agents such as Propofol in children with caudal blockade undergoing lower body surgery.
To evaluate the level of sedation we use the Comfort-B Skala19 ( a sedation score for children). The evaluation starts at skin incision by the surgery (every 10 minutes) until the transfer to the normal ward.

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 24/09/2013
Contact:

ethik-kom@meduniwien.ac.at

Ethikkommission der Medizinischen Universität Wien

(+43)1-40400-21470

ethik-kom@meduniwien.ac.at

Results

Results available:
Date Posted:
Date Completed:	07/10/2015
URL:	http://drks.de/search/en/trial/DRKS00005059#studyResults

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