1)to compare the analgesic efficacy of intravenous versus rectal paracetamol as assessed by VAS scores, PCA morphine consumption.2)To assess the pharmacokinetic profile of intravenous and rectal paracetamol by intravenous plasma paracetamol and…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
postoperatieve pijnbestrijding
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1)Number of requests of PCA during 24 h.
2)Visual analogue scale (100 mm) for pain.
3)Incidence of nausea/vomting, pruritus, hypotension, resp.depression
(SpO2<95% and ventilatory frequency <10) or sedation (using a 10 point sedation
scale) and Ramsey-score.
4)Overall patient satisfaction with pain treatment (5 point scale)
5)Pharmacokinetic data of paracetamol by intravenous blood samples
6)Intravenous morphine concentration and metabolites by iv samples.
Secondary outcome
none
Background summary
Paracetamol is the cornerstone in multimodal postoperative analgesia. With the
exception of contra-indications such as allergy, paracetamol is the basis of
every postoperative analgetic regimen.Paracetamol is administered either as
tablets or suppositories. Recently, an intravenous formulation has become
available.
Study objective
1)to compare the analgesic efficacy of intravenous versus rectal paracetamol as
assessed by VAS scores, PCA morphine consumption.
2)To assess the pharmacokinetic profile of intravenous and rectal paracetamol
by intravenous plasma paracetamol and intravenous plasma morphine
concentrations.
Study design
A randomized, prospective, double-blind placebo-controlled study.
Intervention
Intravenous, rectal paracetamol or placebo and PCA morphine.
Study burden and risks
During the study period there ten blood samples will be taken.
Albinusdreef 2
2333 ZA Leiden
Nederland
Albinusdreef 2
2333 ZA Leiden
Nederland
Listed location countries
Age
Inclusion criteria
ASA class I-III
Patients undergoing lower abdominal laparotomies under general anesthesia
older tha 18 years
men and women
Exclusion criteria
Patients with a BMI >30.
Participation in a trial on investigational drugs within 3 months prior to the study.
Known hypersentivitity to paracetamol.
Known hypersentivitity to opioids.
Known history of hepatic, renal disease or other disease as judged by the investigators.
Those receiving chronic analgesic therapy.
Inability to perform VAS score.
Pregnancy or lactation.
Alcohol or drug abusus or history of alcohol/drug abusus.
Impaired liver function.
Any other reason which in the opinion of the investigator makes the patient unsuitable for participation in the study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-004578-29-NL |
| CCMO | NL14197.058.06 |