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
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
-
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.