Study of the Effect of Dipyrone, Ibuprofen, Paracetamol and Parecoxib on the Platelet Aggregation in Analgetic Dosages

Platelet Aggregation Clinical Trial

Official title:

Study of the Effect of Dipyrone, Ibuprofen, Paracetamol and Parecoxib on the Platelet Aggregation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763997
• Other study ID #: NRA3480005
• Status: Completed
• Phase: N/A
• First received: September 29, 2008
• Last updated: September 29, 2008
• Start date: February 2004
• Est. completion date: December 2004

Study information

• Verified date: September 2008
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Dipyrone is suggested to inhibit the platelet aggregation comparable to th effect of traditional analgetic substances like Ibuprofen. To verify this hypothesis the investigators conducted the study in comparing patients undergoing traumatologic, visceral or plastic surgical procedures. The investigators randomized them to four groups receiving common analgetic doses of either dipyrone, acetaminophen (paracetamol) or valdecoxib/parecoxib. The investigators took blood samples before initiation of the study drug, 1h, 4hs and 24hs after first intake. The investigators compared the aggregation via aggregometry of platelet rich plasma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Planned traumatologic, orthopedic, visceral or plastic surgical procedures

Exclusion Criteria:

• Prior intake of drugs with effect on the platelet aggregation

• Patients with diseases of the gastrointestinal systems

• Patients with cardiac or circulatory diseases

• Patients receiving corticoids

• Patients with cold or asthma

• ASA-classification > 3

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Platelet Aggregation

Intervention

Drug:
• dipyrone
Dipyrone is given in the operation room with 2,5 g intravenously, followed by an oral regime of 4x1g on the ward
• Ibuprofen
Ibuprofen is given orally 600mg in the Post Anesthesia Care Unit, followed by an oral regime of 800mg twice a day
• Acetaminophen
Acetaminophen is given 1g intravenously in the Operation room, followed by an oral regime of 1g fourth a day
• Acetaminophen
Acetaminophen is given 1g intravenously in the operation room, followed by 1g orally fourth a day
• Parecoxib/Valdecoxib
40mg Parecoxib are given intravenously in the operation room, followed by 40mg of Valdecoxib orally twice a day

Other:
• Blood samples
Blood samples for aggregometry are taken before induction of anesthesia, 1h after first drug intake, 4hs and 24hs after first intake

Locations

Country	Name	City	State
Germany	BG University Hospital Bergmannsheil GmbH	Bochum

Sponsors (2)

Lead Sponsor	Collaborator
Ruhr University of Bochum	Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of aggregation in platelet rich plasma fter 24 hours of treatment with analgetic doses		24 hours	No
Secondary	Percentage of aggregation of platelet rich plasma 1hour and 4 hours after initiation of study drug		4 hours	No