A randomised controlled trial investigating the efficacy and safety of topical anaesthetic (0.25% Bupivacaine [Marcain]) in paediatric patients for the management of distress following dental extractions under general anaesthesia

ISRCTN ISRCTN32315461
DOI https://doi.org/10.1186/ISRCTN32315461
Secondary identifying numbers N0453113836
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
14/01/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr IC Mackie
Scientific

Central Manchester Healthcare NHS Trust
Dental Hospital
Higher Cambridge Street
Manchester
M15 6FH
United Kingdom

Phone +44 (0)161 275 6702

Study information

Study designBupivacaine vs standard practice
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOral Health: Anaesthesia/Sedation
InterventionProspective randomised clinical trial comparing use of topical anaesthetic against no postoperative anaesthetic.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Bupivacaine
Primary outcome measureReduction of distress in children who have had teeth extracted under general anaesthesia.
Secondary outcome measuresNot provided at time of registration
Overall study start date04/10/2002
Completion date30/04/2003

Eligibility

Participant type(s)Patient
Age groupChild
SexNot Specified
Target number of participantsAdded January 2009: 135
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment04/10/2002
Date of final enrolment30/04/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Central Manchester Healthcare NHS Trust
Manchester
M15 6FH
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Central Manchester and Manchester Children's University Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2004 Yes No