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ISRCTN
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ISRCTN77607163
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ClinicalTrials.gov identifier
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Public title
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Does paracetamol given by mouth before wisdom tooth extraction give equal pain relief compared to paracetamol given by intravenous infusion?
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Scientific title
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A comparison of pre-medication with oral paracetamol versus intravenous paracetamol given at time of induction for post-operative analgesia following wisdom tooth extraction
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Acronym
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N/A
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Serial number at source
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RPC179
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Study hypothesis
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There is no clinically significant difference between the post-operative analgesic effects of paracetamol when given orally as a pre-medication one hour pre-operatively, and when given as an intravenous infusion immediately pre-operatively.
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Ethics approval
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Ethics approval pending from the Brighton East Research Ethics Committee as of 09/05/2008 (ref: 08/H1107/16).
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Study design
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Randomised, controlled, blinded 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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Analgesia in wisdom tooth extraction
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Participants - inclusion criteria
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Patients over 18 years (either sex) having a general anaesthetic for extraction of wisdom teeth of which at least one must be a lower molar tooth.
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Participants - exclusion criteria
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1. Patients who are unable to give full consent, or who do not wish to take part in the trial
2. Patients who have a baseline Visual Analogue Scale (VAS) score of more than zero
3. Patients unable to swallow tablets
4. Patients who have taken simple analgesics that day, prior to surgery
5. Hypersensitivity or history of serious adverse reactions to paracetamol or non-steroidal anti-inflammatory drugs
6. Active liver disease
7. Renal dysfunction
8. Pregnant or breast feeding women
9. Alcohol or drug abuse
10. History of unresponsiveness to paracetamol
11. Gastric or peptic ulcer disease
12. Inflammatory bowel disease
13. Blood coagulation abnormalities
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Anticipated start date
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31/03/2008
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Anticipated end date
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31/12/2008
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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116
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Interventions
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Participants will be randomly assigned to either:
1. Oral pre-med group: two 500 milligram paracetamol capsules and 100 ml bag of normal saline for injection, or
2. IV group: two placebo lactose capsules and 100 ml (1 gram) of paracetamol for injection
The oral pre-medication will be given one hour prior to surgery and the intravenous whilst the participant is under a general anaesthetic. Duration of treatment 15 minutes for intravenous injection. Duration of follow up until discharged from hospital (max 3 - 4 hours).
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Primary outcome measure(s)
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We will compare the pain scores of patients in the two study arms one hour post-operatively. This will be done in recovery using a Visual Analogue Scale (VAS) pain scoring system.
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Secondary outcome measure(s)
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We will compare the time to request of post-operative ‘rescue’ analgesia between the two study arms. Specifically, this will be measured from when the patient arrives in recovery. This point will serve as a standard ‘time zero’ (t0). The time elapsed before the patient requests additional analgesia (if at all) will act as a secondary surrogate marker of analgesic efficacy.
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Sources of funding
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National Institute for Health Research (UK) - the Research for Patient Benefit (RfPB) programme: applied for funding
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Trial website
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Publications
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Contact name
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Dr
Stephen
Fenlon
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Address
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Queen Victoria Hospital NHS Foundation Trust
Holtye Road
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City/town
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East Grinstead
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Zip/Postcode
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RH19 3QE
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Country
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United Kingdom
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Email
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stephen.fenlon@qvh.nhs.uk
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Sponsor
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Queen Victoria Hospital NHS Foundation Trust (UK)
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Address
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Holtye Road
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City/town
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East Grinstead
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Zip/Postcode
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RH19 3DZ
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Country
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United Kingdom
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Email
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sarah.dawe@qvh.nhs.uk
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Sponsor website:
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http://www.qvh.nhs.uk/
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Date applied
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22/01/2008
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Last edited
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09/05/2008
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Date ISRCTN assigned
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09/05/2008
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