Condition category
Oral Health
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
14/01/2009
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 IC Mackie

ORCID ID

Contact details

Central Manchester Healthcare NHS Trust
Dental Hospital
Higher Cambridge Street
Manchester
M15 6FH
United Kingdom
+44 (0)161 275 6702

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0453113836

Study information

Scientific title

Acronym

Study hypothesis

To investigate the effectiveness of topical anaesthetic (0.25% Bupivacaine) for reducing postoperative distress caused by pain in paediatric patients undergoing dental extractions under general anaesthesia.

Ethics approval

Not provided at time of registration

Study design

Bupivacaine vs standard practice

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

Prospective randomised clinical trial comparing use of topical anaesthetic against no postoperative anaesthetic.

Intervention type

Drug

Phase

Not Specified

Drug names

Bupivacaine

Primary outcome measures

Reduction of distress in children who have had teeth extracted under general anaesthesia.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

04/10/2002

Overall trial end date

30/04/2003

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

Added January 2009: 135

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

04/10/2002

Recruitment end date

30/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Central Manchester Healthcare NHS Trust
Manchester
M15 6FH
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

Central Manchester and Manchester Children's University 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

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15525311

Publication citations

  1. Results

    Gazal G, Bowman R, Worthington HV, Mackie IC, A double-blind randomized controlled trial investigating the effectiveness of topical bupivacaine in reducing distress in children following extractions under general anaesthesia., Int J Paediatr Dent, 2004, 14, 6, 425-431, doi: 10.1111/j.1365-263X.2004.00587.x.

Additional files

Editorial Notes