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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT00763997
First received: September 29, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Platelet Aggregation
 Drug: dipyrone
Drug: Ibuprofen
Drug: Acetaminophen
Drug: Parecoxib/Valdecoxib
Other: Blood samples

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study of the Effect of Dipyrone, Ibuprofen, Paracetamol and Parecoxib on the Platelet Aggregation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • Percentage of aggregation in platelet rich plasma fter 24 hours of treatment with analgetic doses [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of aggregation of platelet rich plasma 1hour and 4 hours after initiation of study drug [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: February 2004
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Drug: Ibuprofen
Ibuprofen is given orally 600mg in the Post Anesthesia Care Unit, followed by an oral regime of 800mg 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
Active Comparator: 3
Acetaminophen
 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
Other: Blood samples
Blood samples for aggregometry are taken before induction of anesthesia, 1h after first drug intake, 4hs and 24hs after first intake
Placebo Comparator: 4
Parecoxib/Valdecoxib
 Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763997

Locations
Germany
BG University Hospital Bergmannsheil GmbH
Bochum, Germany, 44789
Sponsors and Collaborators
Ruhr University of Bochum
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
  More Information

No publications provided

Responsible Party: Matthias Schmauß, MD, scientific associate with the Ruhr Unievrsity Bochum
ClinicalTrials.gov Identifier: NCT00763997     History of Changes
Other Study ID Numbers: NRA3480005
Study First Received: September 29, 2008
Last Updated: September 29, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ruhr University of Bochum:
dipyrone
platelet aggregation
neuraxial blockage
 ibuprofen
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:
Acetaminophen
Dipyrone
Ibuprofen
Valdecoxib
Parecoxib
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013