Condition category
Oral Health
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
26/06/2008
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

Dr P Ashley

ORCID ID

Contact details

Department of Paediatric Dentistry
Eastman Dental Hospital
256 Gray's Inn Road
London
WC1X 8LD
United Kingdom
+44 020 7915 1000
p.ashley@eastman.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0263111537

Study information

Scientific title

Acronym

Study hypothesis

Will the different preoperative local analgesia techniques affect the post-operative discomfort, pain and anxiety experienced in children below 6 years old undergoing dental treatment under general anaesthesia?

Ethics approval

Not provided at time of registration

Study design

Prospective, double blind with a balanced design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Oral Health: Anaesthesia/Sedation

Intervention

1. Perioperative local analgesia delivered by infiltration
2. Perioperative local analgesia delivered by intraligamental injection
3. No perioperative local analgesia

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Level of pain, anxiety and discomfort.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2002

Overall trial end date

01/05/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

120 patients from Paediatric Dentistry

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/03/2002

Recruitment end date

01/05/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Paediatric Dentistry
London
WC1X 8LD
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

University College London Hospitals NHS Trust (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

2007 results published on http://www.ncbi.nlm.nih.gov/pubmed/17694046

Publication citations

  1. Results published

    Leong KJ, Roberts GJ, Ashley PF, Perioperative local anaesthetic in young paediatric patients undergoing extractions under outpatient 'short-case' general anaesthesia. A double-blind randomised controlled trial., Br Dent J, 2007, 203, 6, E11; discussion 334-5, doi: 10.1038/bdj.2007.724.

Additional files

Editorial Notes