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ISRCTN
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ISRCTN35049639
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ClinicalTrials.gov identifier
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Public title
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The effect of emulsion formulation on Propofol injection pain
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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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N0244124360
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Study hypothesis
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Does Propofol Lipuro cause less injection pain than standard Propofol obviating the need to add Lidocaine local anaesthetic?
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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 double blind 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: Anaesthesia
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Participants - inclusion criteria
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Patients scheduled for surgery requiring general anaesthesia in whom Propofol is an appropriate anaesthetic induction agent
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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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01/05/2003
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Anticipated end date
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30/04/2004
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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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200
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Interventions
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Patients were allocated randomly into two groups to receive either Propofol-Lipuro without added lidocaine or Diprivan mixed with lidocaine 10 mg.
5 ml of the study solution was injected at a constant rate over 15 s and patients graded any associated pain or discomfort using a four-point verbal rating scale.
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Primary outcome measure(s)
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Injection pain experienced by patients during induction of general anaesthesia
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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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Stockport NHS Trust (UK)
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Trial website
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Publications
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2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15549974
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Contact name
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Dr
Anthony
McCluskey
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Address
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Birch House
Stepping Hill Hospital
Poplar Grove
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City/town
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Stockport
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Zip/Postcode
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SK2 7JE
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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 - 2004 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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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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30/09/2004
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Last edited
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16/07/2009
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Date ISRCTN assigned
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30/09/2004
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