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
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
-
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.