Condition category
Surgery
Date applied
19/06/2006
Date assigned
28/11/2006
Last edited
04/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kathryn Holder

ORCID ID

Contact details

Consultant Anaesthetist
c/o Anaesthetic Department
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
+44 (0) 117 950 5050 ext 5114
Kathryn.Holder@nbt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

06/Q2002/25

Study information

Scientific title

Acronym

Paracetamol

Study hypothesis

The hypothesis is that in the peri-operative setting gastric emptying is delayed and that the absorption of oral paracetamol preparation is therefore unreliable. It might be more appropriate to use the intravenous route and if so will become apparent during the study.

The aim of this research study is to compare plasma levels of the intravenous and oral paracetamol preparations when used as pre-emptive analgesia. We wish to establish whether the intravenous preparation, the oral preparation or both achieve therapeutic plasma levels intra-operatively. Use of paracetamol as a pre-emptive analgesia is well established in previous studies, which have shown that pre-emptive analgesia reduces post-operative pain more than when analgesia is used solely post-operatively and others have shown that peri-operative use of paracetamol also reduces opioid use.

Therefore, is intravenous paracetamol more effective than the oral preparation when given as a pre-medication?

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled 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

Peri-operative analgesia

Intervention

Group A: Intravenous injection equivalent to one gram paracetamol given by the researchers immediately prior to induction of anaesthesia in theatre.
Group B: One gram oral paracetamol prescribed on the ward and given by the nursing staff or researchers one to two hours before induction of anaesthesia.

Intervention type

Drug

Phase

Not Specified

Drug names

Paracetamol

Primary outcome measures

Therapeutic plasma level of paracetamol (when the plasma level is 10 - 20 mg/l [the test will be at 30 minutes post induction of anaesthesia])

Secondary outcome measures

Non-therapeutic plasma level of paracetamol

Overall trial start date

01/08/2006

Overall trial end date

01/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Assessment of fitness as indicated by the American Society of Anesthesiologists (ASA) grades I and II
2. Age group 16 to 75 years
3. All patients listed for elective surgery by Mr P Robinson on a Thursday for Ear, Nose & Throat surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

104 (52 in each group)

Participant exclusion criteria

1. Patients refusing to participate in study
2. Patient unable to take an oral preparation
3. Cases shorter than one hour
4. Patients already taking a paracetamol containing drug combination, or have taken in the last 12 hours
5. Patients with a history of paracetamol allergy, hypersensitivity or previous reaction/serious adverse reaction
6. Children under the age of 16
7. Patients unable to understand or give consent to participation in the study; incapable adults, psychiatric/medical disorder able to modify patient compliance
8. Pregnant or breastfeeding
9. History of complete non-responsiveness to acetaminophen
10. Pancreatic disease in the previous 12 months
11. Impaired liver/kidney function
12. Patients that might pose an infection risk to staff due to blood products

Recruitment start date

01/08/2006

Recruitment end date

01/08/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Anaesthetist
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust (UK)

Sponsor details

Nicola Coe
c/o Research & Development
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
+44 (0) 117 959 5386/6192
Nicola.Coe@nbt.nhs.uk

Sponsor type

Government

Website

http://www.nbt.nhs.uk/

Funders

Funder type

Government

Funder name

North Bristol NHS Trust (UK)

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

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21485673

Publication citations

  1. Results

    van der Westhuizen J, Kuo PY, Reed PW, Holder K, Randomised controlled trial comparing oral and intravenous paracetamol (acetaminophen) plasma levels when given as preoperative analgesia., Anaesth Intensive Care, 2011, 39, 2, 242-246.

Additional files

Editorial Notes