Condition category
Oral Health
Date applied
09/09/2005
Date assigned
05/10/2005
Last edited
25/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Keith Millar

ORCID ID

Contact details

Psychological Medicine
University of Glasgow
Gartnavel Royal Hospital
Glasgow
G12 0XH
United Kingdom
+44 (0)141 211 3939
k.millar@clinmed.gla.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CZH/4/139

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Placebo controlled randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Midazolam

Primary outcome measures

1. Cognitive function postoperatively
2. Anxiety pre-operatively
3. Interaction between general anaesthesia and midazolam

Secondary outcome measures

Future dental attendance patterns.

Overall trial start date

01/01/2004

Overall trial end date

31/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Children aged 5-10 years having multiple dental extractions under general anaesthesia due to their inability to cope with conscious sedation.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. English not first language
2. Learning disability
3. Neurological disorder
4. Psychiatric disorder
5. Respiratory disorder

Recruitment start date

01/01/2004

Recruitment end date

31/05/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Psychological Medicine
Glasgow
G12 0XH
United Kingdom

Sponsor information

Organisation

Scottish Executive Chief Scientist Office (UK)

Sponsor details

St Andrew's House
Regent Road
Edinburgh
EH1 3DG
United Kingdom
+44 (0)131 244 2285
nick.gosling@scotland.gsi.gov.uk

Sponsor type

Government

Website

http://www.scotland.gov.uk

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 results of effects on postoperative cognition in http://www.ncbi.nlm.nih.gov/pubmed/17697220
2. 2009 results of effects on dental anxiety, anaesthetic induction and psychological morbidity in http://www.ncbi.nlm.nih.gov/pubmed/19574992

Publication citations

  1. Results of effects on postoperative cognition

    Millar K, Asbury AJ, Bowman AW, Hosey MT, Martin K, Musiello T, Welbury RR, A randomised placebo-controlled trial of the effects of midazolam premedication on children's postoperative cognition., Anaesthesia, 2007, 62, 9, 923-930, doi: 10.1111/j.1365-2044.2007.05148.x.

  2. Hosey MT, Asbury AJ, Bowman AW, Millar K, Martin K, Musiello T, Welbury R, The effect of transmucosal 0.2 mg/kg midazolam premedication on dental anxiety, anaesthetic induction and psychological morbidity in children undergoing general anaesthesia for tooth extraction., Br Dent J, 2009, 207, 1, E2; discussion 32-3, doi: 10.1038/sj.bdj.2009.570.

Additional files

Editorial Notes