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Will paracetamol reduce the opioid requirements and the (opioid)related postoperative nausea?

Will paracetamol reduce the opioid requirements and the (opioid)related postoperative nausea?

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-000351-33-SE
Enrollment
140
Registered
2007-03-05
Start date
2007-07-26
Completion date
Unknown
Last updated
2013-09-23

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

Conditions

Paracetamol is used as a complimentary painrelief. Using sealed envelopes, 140 patients will be randomly assigned to receive either 1g paracetamol as tablets (Panodil® Glaxo Smith Kline) or 1g placebo every 6th hour after heartsurgery for 3 days. The occurrence of postoperative nausea will be assessed. Pain will be evaluated. The total amount of opioids will be noted and calculated. After the study we will break the code with sealed envelopes. MedDRA version: 9.1 Level: LLT Classification c

Interventions

Trade Name: Panodil (paracetamol) Product Name: Paracetamol Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Sponsors

Karolinska Universitetssjukhuset Solna
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 140 patients , undergoing heart surgery will be randomised upon arrival to the intensive care unit to receive either paracetamol every 6th hour or placebo. 18 years and older. 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 not suited for paracetamol. Non conversationable. Women.

Design outcomes

Primary

MeasureTime frame
Main Objective: Will paracetamol reduce the opioid requirements and the (opioid)related postoperative nausea? ;Secondary Objective: Will paracetamol reduce PONV (postoperative nausea and vomiting) and pain?;Primary end point(s): Will paracetamol reduce opioid requirements and also the opioid related nausea without increased pain.

Countries

Sweden

Outcome results

None listed

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