Dettagli per singolo studio

DEC-NET Serial number GB280

Published online	07/07/2004 15.16.00
Last updated	02/08/2005 14.10.20

Other protocol ID number	N0394131463
This trial has been approved by an ethics committee
Current trial status	Open (actively recruiting new participants)
First subject enrolment Target N. of subjects	10/2003 35
Major Disease (ICD9 class)	DENTAL DISORDER NOS
Experimental drug
Propofol (intravenous) Treatment regimen (dosage and duration) Dose not given
Control drug
General Anaesthetic Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	10-16 years
Eligibility criteria
Inclusion criteria
Emotionally mature adolescents aged between 10 and 16 years referred to the Wednesday afternoon paediatric dentistry sedation list.
Exclusion criteria
informed consent not given
Trial design/methodology
Phase	4
Kind of study	Efficacy
Design	Controlled
Purpose of study
To determine whether propofol intravenous sedation reduces anxiety following it's use to enable dental treatment in children aged between 10 and 16 years? Is this anxiety reduction better than that produced by general anaesthesia?
Primary outcomes
- Modified Dental Anxiety Scale (mDAS) - Child fear study schedule - Visual analogue scale - Quantification of treatment completed


Summary of study design, objectives, and ongoing research findings
Questionnaires/interviews, controlled trial without randomisation, before-after study, cohort observation. The study aims to determine whether propofol intravenous sedation reduces anxiety following it's use to enable dental treatment in children aged between 10 and 16 years? It also aims to determine whether this anxiety reduction is better than that produced by general anaesthesia?