Clinical evaluation of the effects of paediatric dental general anaesthesia and midazolam sedation on cognitive function, anxiety and access to future dental care

ISRCTN	ISRCTN12026431
DOI	https://doi.org/10.1186/ISRCTN12026431
Secondary identifying numbers	CZH/4/139

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Keith Millar
Scientific

Psychological Medicine
University of Glasgow
Gartnavel Royal Hospital
Glasgow
G12 0XH
United Kingdom

Phone	+44 (0)141 211 3939
Email	k.millar@clinmed.gla.ac.uk

Study design	Placebo controlled randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	The study is a prospective, placebo-controlled and randomised trial of midazolam premedication for dental general anaesthesia. It is hypothesised that: 1. Midazolam will interact with general anaesthesia to exacerbate postanaesthetic cognitive impairment 2. Midazolam will reduce pre-operative anxiety and facilitate children's coping with the procedure 3. The reduction in anxiety will be associated with improved future dental attendance patterns
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Dental caries requiring multiple extractions
Intervention	1. General anaesthesia due to child's inability to cope whilst conscious 2. Midazolam versus placebo to reduce pre-operative anxiety
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Midazolam
Primary outcome measure	1. Cognitive function postoperatively 2. Anxiety pre-operatively 3. Interaction between general anaesthesia and midazolam
Secondary outcome measures	Future dental attendance patterns.
Overall study start date	01/01/2004
Completion date	31/05/2006

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Years
Upper age limit	10 Years
Sex	Both
Target number of participants	200
Key inclusion criteria	Children aged 5-10 years having multiple dental extractions under general anaesthesia due to their inability to cope with conscious sedation.
Key exclusion criteria	1. English not first language 2. Learning disability 3. Neurological disorder 4. Psychiatric disorder 5. Respiratory disorder
Date of first enrolment	01/01/2004
Date of final enrolment	31/05/2006

Psychological Medicine

Glasgow
G12 0XH
United Kingdom

Scottish Executive Chief Scientist Office (UK)
Government

St Andrew's House
Regent Road
Edinburgh
EH1 3DG
United Kingdom

Phone	+44 (0)131 244 2285
Email	nick.gosling@scotland.gsi.gov.uk
Website	http://www.scotland.gov.uk
"ROR"	https://ror.org/01613vh25

Government

Scottish Executive Chief Scientist Office (ref: CZH/4/139) (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results of effects on postoperative cognition	01/09/2007		Yes	No
Results article	results of effects on dental anxiety, anaesthetic induction and psychological morbidity	11/07/2009		Yes	No