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ISRCTN
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ISRCTN72395027
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ClinicalTrials.gov identifier
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Public title
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The use of pre-operative analgesia and intra-operative intra-crestal anaesthesia on teeth being extracted or restored under general anaesthetic for post-operative pain control in paediatric dentistry.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0013160113
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Study hypothesis
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To evaluate the effectiveness of pre-emptive analgesia in children aged 5-12 years undergoing a dental general anaesthetic (DGA) for dental extractions +/- restorations.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Oral Health
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Participants - inclusion criteria
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Children aged 5-12 years undergoing DGA requiring symmetrical extractions +/- restorations under day stay DGA.
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Participants - exclusion criteria
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1. Children unsuitable for day case dental general anaesthesia
2. Children aged < 5 years old
3. Children aged > 12 years old
4. Children at risk of endocarditis
5. Children with learning disabilities
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Anticipated start date
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01/06/2004
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Anticipated end date
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01/06/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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This is a randomised controlled trial utilising the half mouth design whereby patients undergoing extractions +/- restorative care will receive intra-setpal/crestal local anaesthetic in one side of the mouth versus nothing in the control side - each child will act as their own control. Standard post operative analgesia will be administered.
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Primary outcome measure(s)
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The effectiveness of intra-crestal analgesia for pain control in children.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Guy's and St. Thomas' NHS Foundation Trust (UK) Own account NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Miss
Joanna
Johnson
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Address
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Paediatric Dentistry
22nd Floor, Guy's Tower
Guy's Hospital
St Thomas' Street
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City/town
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London
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Zip/Postcode
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SE1 9RT
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Country
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United Kingdom
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Tel
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+44 (0)20 7881 7881
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Email
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Joanna.johnson@kcl.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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15/07/2010
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Date ISRCTN assigned
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30/09/2005
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