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Completed

NCT Number: NCT00763997

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

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.

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Key information

Conditions

Platelet Aggregation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BG University Hospital Bergmannsheil GmbH

Bochum, 44789, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dipyrone

Drug

Dipyrone is given in the operation room with 2,5 g intravenously, followed by an oral regime of 4x1g on the ward

Ibuprofen

Drug

Ibuprofen is given orally 600mg in the Post Anesthesia Care Unit, followed by an oral regime of 800mg twice a day

Acetaminophen

Drug

Acetaminophen is given 1g intravenously in the Operation room, followed by an oral regime of 1g fourth a day

Parecoxib/Valdecoxib

Drug

40mg Parecoxib are given intravenously in the operation room, followed by 40mg of Valdecoxib orally twice a day

Blood Samples

Other

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

Primary outcomes

  1. Percentage of aggregation in platelet rich plasma fter 24 hours of treatment with analgetic doses

    Time frame: 24 hours

Secondary outcomes

  1. Percentage of aggregation of platelet rich plasma 1hour and 4 hours after initiation of study drug

    Time frame: 4 hours

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Oct 1, 2008
Registry last updated
Oct 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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