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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15525311
Publication citations
-
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.