The efficacy of intravenous versus rectal paracetamol: A randomized, prospective, double-blind placebo-controlled study
Completed
- Conditions
- postoperatieve pijnbestrijdingpostoperative pain management
- Registration Number
- NL-OMON30232
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1)Number of requests of PCA during 24 h.<br /><br>2)Visual analogue scale (100 mm) for pain.<br /><br>3)Incidence of nausea/vomting, pruritus, hypotension, resp.depression<br /><br>(SpO2<95% and ventilatory frequency <10) or sedation (using a 10 point sedation<br /><br>scale) and Ramsey-score.<br /><br>4)Overall patient satisfaction with pain treatment (5 point scale)<br /><br>5)Pharmacokinetic data of paracetamol by intravenous blood samples<br /><br>6)Intravenous morphine concentration and metabolites by iv samples.</p><br>
- Secondary Outcome Measures
Name Time Method <p>none</p><br>