The efficacy of intravenous versus rectal paracetamol: A randomized, prospective, double-blind placebo-controlled study

Conditions: Aims of the study1)to compare the analgesic efficacy of intravenous versus rectal paracetamol versus placebo as assessed by VAS scores and PCA morphine consumption. 2)To assess the pharmacokinetic profile of intravenous and rectal paracetamol by intravenous plasma paracetamol concentrations.

Registration Number: EUCTR2006-004578-29-NL

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 90

Inclusion Criteria

ASA class I-III
Patients undergoing lower abdominal laparotomies under general anesthesia.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: comparison of postoperative analgesic effect of paracetamol suppositoria with paracetamol intravenously, measured by postoperative morfine consumption.;Secondary Objective: plasma level of paracetamol, morfine and morfine metabolites postoperatively.;Primary end point(s): 1)Number of requests of PCA during 24 h.<br>2)Visual analogue scale (100 mm) for pain.<br>3)Incidence of nausea/vomting, pruritus, hypotension, resp.depression <br>(SpO2<95% and ventilatory frequency <10) or sedation (using a 10 point sedation scale) and Ramsey-score.<br>4)Overall patient satisfaction with pain treatment (5 point scale)<br>5)Pharmacokinetic data of paracetamol by intravenous blood samples <br>6)Intravenous morphine concentration and metabolites by iv samples<br>

Secondary Outcome Measures