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ISRCTN
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ISRCTN71821503
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ClinicalTrials.gov identifier
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Public title
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Validation of analgesic effect of nitrous oxide in neonates and infants.
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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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N0060055834
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Study hypothesis
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The purpose of this research is to validate the analgesic effect of nitrous oxide (N20) in neonates and infants.
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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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Neonatal and infant analgesia
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Participants - inclusion criteria
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1. Pre-term newborns (32 - 37 weeks), n = 90
2. Full-term newborns (38 - 42 weeks), n = 90
3. Infants (1 - 3 months), n = 90
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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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01/05/2000
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Anticipated end date
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31/10/2005
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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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270
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Interventions
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Prospectively randomised, placebo-controlled, clinical trial. Patients randomised to:
1. Nitrous oxide
2. Placebo
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Primary outcome measure(s)
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1. Neonatal pain assessment tool (developed by Keeble and Twaddle [1995])
2. Physiologic parameters:
2.1. Blood pressure
2.2. Heart rate
2.3. Respiratory rate
2.4. Oxygen saturation
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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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1. Chelsea and Westminster NHS Foundation Trust (UK) - NHS R&D Support Funding
2. Imperial College School of Medicine (ICSM) (UK) - Research Funds
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Trial website
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Publications
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Contact name
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Prof
Mervyn
Maze
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Address
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Magill Dept of Anaesthesia, 3rd floor
Chelsea & Westminster Hospital
369 Fulham Road
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City/town
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London
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Zip/Postcode
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SW10 9NH
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Country
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United Kingdom
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Tel
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+44 (0)181 746 8035/8816
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Fax
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+44 (0)181 237 5109
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Email
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m.maze@imperial.ac.uk
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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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10/02/2011
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Date ISRCTN assigned
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30/09/2004
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