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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004578-29-NL

Enrollment

Registered

2006-09-01

Start date

2007-06-15

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aims of the study 1)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.

Interventions

Trade Name: paracetamol Product Name: paracetamol Pharmaceutical Form: Suppository Pharmaceutical form of the placebo: Suppository Route of administration of the placebo: Rectal use Pharmaceutical for

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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. 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	—

Measure

Time frame

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. 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

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026