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

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

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.

Study Overview

• Status: Completed
• Conditions: Platelet Aggregation
• Intervention / Treatment: Drug: dipyrone; Other: Blood samples; Drug: Ibuprofen; Drug: Acetaminophen; Drug: Acetaminophen; Drug: Parecoxib/Valdecoxib

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bochum, Germany, 44789
    • BG University Hospital Bergmannsheil GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Dipyrone	Drug: dipyrone; Dipyrone is given in the operation room with 2,5 g intravenously, followed by an oral regime of 4x1g on the ward; Other: Blood samples; Blood samples for aggregometry are taken before induction of anesthesia, 1h after first drug intake, 4hs and 24hs after first intake
Active Comparator: 2; Ibuprofen	Other: Blood samples; Blood samples for aggregometry are taken before induction of anesthesia, 1h after first drug intake, 4hs and 24hs after first intake; Drug: Ibuprofen; Ibuprofen is given orally 600mg in the Post Anesthesia Care Unit, followed by an oral regime of 800mg twice a day
Active Comparator: 3; Acetaminophen	Other: Blood samples; Blood samples for aggregometry are taken before induction of anesthesia, 1h after first drug intake, 4hs and 24hs after first intake; Drug: Acetaminophen; Acetaminophen is given 1g intravenously in the Operation room, followed by an oral regime of 1g fourth a day; Drug: Acetaminophen; Acetaminophen is given 1g intravenously in the operation room, followed by 1g orally fourth a day
Placebo Comparator: 4; Parecoxib/Valdecoxib	Other: Blood samples; Blood samples for aggregometry are taken before induction of anesthesia, 1h after first drug intake, 4hs and 24hs after first intake; Drug: Parecoxib/Valdecoxib; 40mg Parecoxib are given intravenously in the operation room, followed by 40mg of Valdecoxib orally twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of aggregation in platelet rich plasma fter 24 hours of treatment with analgetic doses	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of aggregation of platelet rich plasma 1hour and 4 hours after initiation of study drug	4 hours

Collaborators and Investigators

• Sponsor: Ruhr University of Bochum
• Collaborators: Pfizer
• Investigators: Principal Investigator: Matthias Schmauss, MD, research associate of the Ruhr University Bochum; Study Chair: Christoph Maier, Professor, Leader of the Department for Pain Medicine of the University Hospital Bergmannsheil Bochum

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: September 29, 2008
• First Submitted That Met QC Criteria: September 29, 2008
• First Posted (Estimate): October 1, 2008

Study Record Updates

• Last Update Posted (Estimate): October 1, 2008
• Last Update Submitted That Met QC Criteria: September 29, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: platelet aggregation; ibuprofen; dipyrone; neuraxial blockage; platelet aggregation under dipyrone compared to ibuprofen, acetaminophen and parecoxib/valdecoxib; neuraxial blockage in patients receiving ibuprofen is critical in special circumstances, but traditionally not fpr dipyrone
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Cyclooxygenase 2 Inhibitors; Acetaminophen; Ibuprofen; Valdecoxib; Dipyrone; Parecoxib
• Other Study ID Numbers: NRA3480005