Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen Fenlon

ORCID ID

Contact details

Queen Victoria Hospital NHS Foundation Trust
Holtye Road
East Grinstead
RH19 3QE
United Kingdom
stephen.fenlon@qvh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RPC179

Study information

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

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.

Ethics approval

Brighton East Research Ethics Committee approved as of 19th February 2008 (ref: 08/H1107/16)

Study design

Randomised, controlled, blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Analgesia in wisdom tooth extraction

Intervention

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).

Intervention type

Drug

Phase

Not Specified

Drug names

Paracetamol

Primary outcome measures

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 measures

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.

Overall trial start date

31/03/2008

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

116

Participant 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

Recruitment start date

31/03/2008

Recruitment end date

31/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Victoria Hospital NHS Foundation Trust
East Grinstead
RH19 3QE
United Kingdom

Sponsor information

Organisation

Queen Victoria Hospital NHS Foundation Trust (UK)

Sponsor details

Holtye Road
East Grinstead
RH19 3DZ
United Kingdom
sarah.dawe@qvh.nhs.uk

Sponsor type

Government

Website

http://www.qvh.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (UK) - the Research for Patient Benefit (RfPB) programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23220855

Publication citations

  1. Results

    Fenlon S, Collyer J, Giles J, Bidd H, Lees M, Nicholson J, Dulai R, Hankins M, Edelman N, Oral vs intravenous paracetamol for lower third molar extractions under general anaesthesia: is oral administration inferior?, Br J Anaesth, 2013, 110, 3, 432-437, doi: 10.1093/bja/aes387.

Editorial Notes