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Does paracetamol given by mouth before wisdom tooth extraction give equal pain relief compared to paracetamol given by intravenous infusion?
ISRCTN ISRCTN77607163
DOI 10.1186/ISRCTN77607163
ClinicalTrials.gov identifier
EudraCT number
Public title Does paracetamol given by mouth before wisdom tooth extraction give equal pain relief compared to paracetamol given by intravenous infusion?
Scientific title A comparison of pre-medication with oral paracetamol versus intravenous paracetamol given at time of induction for post-operative analgesia following wisdom tooth extraction
Acronym N/A
Serial number at source RPC179
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Brighton East Research Ethics Committee approved as of 19th February 2008 (ref: 08/H1107/16)
Study design Randomised, controlled, blinded trial
Countries of recruitment United Kingdom
Disease/condition/study domain Analgesia in wisdom tooth extraction
Participants - inclusion criteria 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.
Participants - exclusion criteria 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
Anticipated start date 31/03/2008
Anticipated end date 31/12/2008
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 116
Interventions 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).
Primary outcome measure(s) 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.
Secondary outcome measure(s) 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.
Sources of funding National Institute for Health Research (UK) - the Research for Patient Benefit (RfPB) programme
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23220855
Contact name Dr  Stephen  Fenlon
  Address Queen Victoria Hospital NHS Foundation Trust
Holtye Road
  City/town East Grinstead
  Zip/Postcode RH19 3QE
  Country United Kingdom
  Email stephen.fenlon@qvh.nhs.uk
Sponsor Queen Victoria Hospital NHS Foundation Trust (UK)
  Address Holtye Road
  City/town East Grinstead
  Zip/Postcode RH19 3DZ
  Country United Kingdom
  Email sarah.dawe@qvh.nhs.uk
  Sponsor website: http://www.qvh.nhs.uk/
Date applied 22/01/2008
Last edited 12/12/2012
Date ISRCTN assigned 09/05/2008
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