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ISRCTN
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ISRCTN60349285
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ClinicalTrials.gov identifier
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Public title
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A comparison of midazolam with fentanyl or pethidine as a sedation for colonoscopy.
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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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N0649155306
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Study hypothesis
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Is there a significant difference between midazolam + fentanyl or midazolam + pethidine for colonoscopy sedation in terms of discomfort experienced by patients.
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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: Colonoscopy
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Participants - inclusion criteria
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All patients attending for colonoscopy (approx 2000 per year) will be eligible.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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20/02/2005
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Anticipated end date
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31/12/2006
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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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2000
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Interventions
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Patients must receive sedation for colonoscopy. They will be randomised to receive one of the two drug combinations, both of which are already used in this Trust. There will be no cost, safety or training implications, as the study will use existing practice and protocols. Data will be collected to compare efficacy, safety and acceptability of the two combinations.
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Primary outcome measure(s)
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1. Patient pain experienced/recalled
2. Comparison between two sedation regimes
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Secondary outcome measure(s)
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1. Experience of pain related to Endoscopist
2. Patient expectation pre-endoscopy
3. Friendliness of staff
4. Incidence of adverse events during endoscopy
5. Need for more sedative
6. Desaturation
7. Agitation
8. Time taken for endoscopy (completion rate)
9. Time taken for recovery
10. Does patient's perception differ from Endoscopist, Nurse?
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Sources of funding
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Queen Elizabeth Hospital NHS Trust (UK)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19251010
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Contact name
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Dr
Alistair
McNair
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Address
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Consultant Gastroenetrologist
Queen Elizabeth Hospital NHS Trust
Stadium Road
Woolwich
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City/town
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London
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Zip/Postcode
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SE18 4QH
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Country
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United Kingdom
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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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12/04/2011
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Date ISRCTN assigned
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30/09/2005
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