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ISRCTN
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ISRCTN81142957
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ClinicalTrials.gov identifier
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Public title
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Randomised Controlled Trial of sedation for colonoscopy: Entonox versus Midazolam/Fentanyl
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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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N0084160165
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Study hypothesis
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Does nitrous oxide (Entonox) provide better pain relief than the conventional intravenous sedation during colonoscopy
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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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Surgery: Sedation
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Participants - inclusion criteria
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All patients undergoing elective colonoscopy would be prospective participants.
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Participants - exclusion criteria
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1. History of chronic respiratory disease
2. History of colonic resection
3. Intolerance to the drugs
4. Patients with pre-existing adbominal or perianal pain
5. Unwilling participants
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Anticipated start date
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11/03/2005
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Anticipated end date
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10/02/2006
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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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100
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Interventions
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Prospective randomised controlled study. Pilot study initially involving 100 patients to determine statistical power.
Pts will be randomised using the sealed envelope method of block randomisation. Patients randomised to the entonox group will be taught methods of use. Patients will be shown the visual analogue score for pain and asked to mark them.
Those randomised to conventional intravenous sedation will be informed of same and will undergo colonoscopy using standard intravenous sedation protocols.
Entonox group encouraged to inhale the nitrous oxide for a full 60 seconds initially and then as and when required throughout procedure. Post colonoscopy both groups will be asked to indicate pain using visual analogue scale in the recovery.
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Primary outcome measure(s)
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Pain score assessed by VAS
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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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The North and South Bank Research and Development Consortium (UK) - NHS R&D Support Funding
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Trial website
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Publications
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2009 conference proceedings in http://www.ncbi.nlm.nih.gov/pubmed/19283736
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Contact name
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Mr
Graeme
Duthie
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Address
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Acadmemic Surgical Unit
Hull and East Yorkshire Hospitals (NHS) Trust
Castle Hill Hospital
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City/town
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Hull
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Zip/Postcode
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HU16 5JQ
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Country
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United Kingdom
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Tel
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+44 (0)1482 623247
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Fax
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+44 (0)1482 623274
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Email
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G.S.Duthie@hull.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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25/06/2010
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Date ISRCTN assigned
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30/09/2005
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