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ISRCTN
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ISRCTN08630314
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ClinicalTrials.gov identifier
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Public title
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Prophylaxis against Postoperative Vomiting (PaPoV) study: a prospective, controlled randomised double-blind trial comparing antiemetic prophylaxis with ondansetron, cyclizine and placebo (normal saline) in children undergoing plastic genito-urinary (GU) procedures
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Scientific title
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Acronym
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PaPoV
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Serial number at source
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N0557102800
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Study hypothesis
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To assess the incidence of postoperative vomiting in children undergoing genital plastic surgery in a prospective, randomised, double blind study comparing ondansetron with cyclizine and placebo (normal saline).
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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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Signs and Symptoms: Vomiting
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Participants - inclusion criteria
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Children undergoing elective plastic genito-urinary procedures between the ages of 3 and 5, American Society of Anesthesiologists (ASA) grade I & II. 55 Children in each group.
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/01/1997
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Anticipated end date
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30/09/2003
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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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110
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Interventions
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Prospective, controlled randomised double-blind trial.
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Primary outcome measure(s)
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Number of vomits in the first 24 h from the time of extubation; doses of anti-emetics given because of vomiting in the first 24 h; time to first oral intake; complications (obtained retrospectively from case notes).
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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 Dudley Group of Hospitals NHS Trust (UK)
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Trial website
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Publications
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2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12886917
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Contact name
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Dr
Philip
Whitehurst
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Address
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Consultant Anaesthetist
Russells Hall Hospital
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City/town
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Dudley
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Zip/Postcode
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DY1 2HQ
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Country
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United Kingdom
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - 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.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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09/07/2009
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Date ISRCTN assigned
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12/09/2003
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