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ISRCTN
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ISRCTN59683871
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ClinicalTrials.gov identifier
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Public title
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Pain relief in children after day-case tonsillectomy.
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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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N0112133830
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Study hypothesis
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The provision of a painkiller chart to parents of children undergoing tonsillectomy does not reduce pain and improve recovery in children after the procedure.
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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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Signs and Symptoms: Post-operative pain
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Participants - inclusion criteria
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1. Will be aged 5-10 years
2. Will be undergoing tonsillectomy as a day case procedure at Queen Mary's Hospital Day Theatre
3. Will be healthy children, American Society of Anesthesiologists (ASA) I and II
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Participants - exclusion criteria
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Children already on analgesics, children who have a contraindication or allergy to ibuprofen/paracetamol and children who experience unexpected complications perioperatively.
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Anticipated start date
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01/09/2003
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Anticipated end date
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31/08/2004
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Please note that as of 26/05/10 the status of this trial was changed to "stopped". The trial was discontinued due to lack of funding.
1. Parents of the child booked in for day case tonsillectomy will receive a Patients Information Sheet at their out-patients appointment
2. The anaesthetist concerned will obtain consent for participation in the study from the child's parent on the morning of the surgery
3. The children will be randomised by St Helier on the day surgery unit
4. They will receive a standard anaesthetic and have routine monitoring
5. The children will have routine recovery care
6. They will have standard painkillers to take home with written instructions on bottle
7. Information on discharge: anaesthetist tells parents to give analgesia regularly to their child, even if not in pain. Both groups to receive pain score and recovery indicator questionnaire
8. One group will receive a "painkiller chart" and the control group will not
9. Parents will receive telephone call on day 1, 3 and 7 after tonsillectomy to remind them to fill out questionnaire.
10. Questionnaire will be collected at the two week follow-up clinic by Mr Rathod, Ear, Nose and Throat (ENT) Surgeon
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Primary outcome measure(s)
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1. Pain scores as measured on two separate visual analogue scales
2. Recovery indicators i.e. time to normal diet, time to normal sleeping patterns, nausea and vomiting and need to ring hospital/GP for advice regarding pain control
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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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Epsom and St Helier University Hospitals NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
Lenny
Ng
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Address
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Epsom and St Helier University Hospitals NHS Trust
Department of Anaesthesia
St Helier Hospital
Wrythe Lane
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City/town
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Carshalton
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Zip/Postcode
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SM5 1AA
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Country
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United Kingdom
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Tel
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+44 (0)208 296 2444
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Fax
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+44 (0)208 296 2951
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Email
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Lenny.ng@doctors.org.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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26/05/2010
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Date ISRCTN assigned
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30/09/2004
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