Comparing oral and intravenous paracetamol plasma levels when given as pre-medication for peri-operative analgesia
| ISRCTN | ISRCTN11248599 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11248599 |
| Secondary identifying numbers | 06/Q2002/25 |
- Submission date
- 19/06/2006
- Registration date
- 28/11/2006
- Last edited
- 04/03/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Kathryn Holder
Scientific
Scientific
Consultant Anaesthetist
c/o Anaesthetic Department
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
| Phone | +44 (0) 117 950 5050 ext 5114 |
|---|---|
| Kathryn.Holder@nbt.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | Paracetamol |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Paracetamol |
| Primary outcome measure | 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 study start date | 01/08/2006 |
| Completion date | 01/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 104 (52 in each group) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2006 |
| Date of final enrolment | 01/08/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Consultant Anaesthetist
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Sponsor information
North Bristol NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Nicola Coe
c/o Research & Development
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
England
United Kingdom
| Phone | +44 (0) 117 959 5386/6192 |
|---|---|
| Nicola.Coe@nbt.nhs.uk | |
| Website | http://www.nbt.nhs.uk/ |
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
Government
North Bristol NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2011 | Yes | No |
