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

NCT ID: NCT00763997

Last Updated: 2008-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2004-12-31

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.

Detailed Description

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Conditions

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Platelet Aggregation

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Dipyrone

Group Type EXPERIMENTAL

dipyrone

Intervention Type DRUG

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

Blood samples

Intervention Type OTHER

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

2

Ibuprofen

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

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

Blood samples

Intervention Type OTHER

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

3

Acetaminophen

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

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

Acetaminophen

Intervention Type DRUG

Acetaminophen is given 1g intravenously in the operation room, followed by 1g orally fourth a day

Blood samples

Intervention Type OTHER

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

4

Parecoxib/Valdecoxib

Group Type PLACEBO_COMPARATOR

Parecoxib/Valdecoxib

Intervention Type DRUG

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

Blood samples

Intervention Type OTHER

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

Interventions

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dipyrone

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

Intervention Type DRUG

Ibuprofen

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

Intervention Type DRUG

Acetaminophen

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

Intervention Type DRUG

Acetaminophen

Acetaminophen is given 1g intravenously in the operation room, followed by 1g orally fourth a day

Intervention Type DRUG

Parecoxib/Valdecoxib

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

Intervention Type DRUG

Blood samples

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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MD, scientific associate with the Ruhr Unievrsity Bochum

Principal Investigators

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Matthias Schmauss, MD

Role: PRINCIPAL_INVESTIGATOR

research associate of the Ruhr University Bochum

Christoph Maier, Professor

Role: STUDY_CHAIR

Leader of the Department for Pain Medicine of the University Hospital Bergmannsheil Bochum

Locations

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BG University Hospital Bergmannsheil GmbH

Bochum, , Germany

Site Status

Countries

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Germany

Other Identifiers

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NRA3480005

Identifier Type: -

Identifier Source: org_study_id