| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN11248599 |
| Date ISRCTN assigned | 28/11/2006 |
| Local reference number(s) | 06/Q2002/25 |
| Public title | Comparing oral and intravenous paracetamol plasma levels when given as pre-medication for peri-operative analgesia |
| Scientific title |
|
| Acronym | Paracetamol |
| Disease/condition/study domain | Peri-operative analgesia |
| 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? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/08/2006 |
| Anticipated end date | 01/08/2007 |
| Status of trial | Completed |
| Target number of participants | 104 (52 in each group) |
| Interventions | 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. |
| Primary outcome measure(s) | 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 measure(s) | Non-therapeutic plasma level of paracetamol |
| Sources of funding | North Bristol NHS Trust (UK) |
| Sponsor name | North Bristol NHS Trust (UK) |
| Sponsor details | Nicola Coe
c/o Research & Development
Southmead Hospital
Westbury-on-Trym
Bristol
United Kingdom
BS10 5NB |
| Sponsor telephone | +44 (0) 117 959 5386/6192 |
| Sponsor email | Nicola.Coe@nbt.nhs.uk |
| Sponsor website | http://www.nbt.nhs.uk/ |
| Contact name | Dr Kathryn Holder |
| Contact details | Consultant Anaesthetist
c/o Anaesthetic Department
Southmead Hospital
Bristol
United Kingdom
BS10 5NB |
| Contact telephone | +44 (0) 117 950 5050 ext 5114 |
| Contact email | Kathryn.Holder@nbt.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN11248599 |
| Date last extracted from ISRCTN register | 17/04/2008 |
