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

NCT00763997 | Completed

• 1 other identifier: NRA3480005
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Platelet Aggregation

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  24 hours

Secondary Outcomes (1)

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

  4 hours

Study Arms (4)

1

EXPERIMENTAL

Dipyrone

Drug: dipyrone; Other: Blood samples

2

ACTIVE COMPARATOR

Ibuprofen

Drug: Ibuprofen; Other: Blood samples

3

ACTIVE COMPARATOR

Acetaminophen

Drug: Acetaminophen; Other: Blood samples

4

PLACEBO COMPARATOR

Parecoxib/Valdecoxib

Drug: Parecoxib/Valdecoxib; Other: Blood samples

Interventions

dipyrone DRUG

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

1

Ibuprofen DRUG

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

2

Acetaminophen DRUG

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

3

Parecoxib/Valdecoxib DRUG

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

4

Blood samples OTHER

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

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned traumatologic, orthopedic, visceral or plastic surgical procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruhr University of Bochum: lead
• Pfizer: collaborator

Study Sites (1)

BG University Hospital Bergmannsheil GmbH

Bochum, 44789, Germany

Location

MeSH Terms

Interventions

Dipyrone; Ibuprofen; Acetaminophen; parecoxib; valdecoxib; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Matthias Schmauss, MD

  research associate of the Ruhr University Bochum

  PRINCIPAL INVESTIGATOR

• Christoph Maier, Professor

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 29, 2008
• First Posted: October 1, 2008
• Study Start: February 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: October 1, 2008

Record last verified: 2008-09

Locations

DE (1)