Condition category
Oral Health
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
19/09/2013
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

Miss Joanna Johnson

ORCID ID

Contact details

Paediatric Dentistry
22nd Floor
Guy's Tower
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom
+44 (0)20 7881 7881

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013160113

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the effectiveness of pre-emptive analgesia in children aged 5-12 years undergoing a dental general anaesthetic (DGA) for dental extractions +/- restorations.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Oral Health

Intervention

This is a randomised controlled trial utilising the half mouth design whereby patients undergoing extractions +/- restorative care will receive intra-setpal/crestal local anaesthetic in one side of the mouth versus nothing in the control side - each child will act as their own control. Standard post operative analgesia will be administered.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The effectiveness of intra-crestal analgesia for pain control in children.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2004

Overall trial end date

01/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Children aged 5-12 years undergoing DGA requiring symmetrical extractions +/- restorations under day stay DGA.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Children unsuitable for day case dental general anaesthesia
2. Children aged < 5 years old
3. Children aged > 12 years old
4. Children at risk of endocarditis
5. Children with learning disabilities

Recruitment start date

01/06/2004

Recruitment end date

01/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Paediatric Dentistry
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Guy's and St. Thomas' NHS Foundation Trust (UK) Own account NHS R&D Support Funding

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

Publication citations

Additional files

Editorial Notes