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

Study Overview
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Brief Summary
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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.

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

Conditions
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Platelet Aggregation

Intervention / Treatment
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* Drug: dipyrone
* Drug: Ibuprofen
* Drug: Acetaminophen
* Drug: Acetaminophen
* Drug: Parecoxib/Valdecoxib
* Other: Blood samples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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