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Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions

4. November 2026 aktualisiert von: Matheus Furtado de Carvalho

Hematological Alterations Associated With the Use of Dipyrone Versus Paracetamol After Dental Extractions: a Double-blind, Randomized Clinical Trial

The goal of this clinical trial is to compare the safety of dipyrone and paracetamol when used for pain relief after dental extractions in adults. The study will focus on changes in blood cell counts and will also evaluate liver and kidney function and possible side effects. The main questions it aims to answer are:

  • Do dipyrone and paracetamol have different effects on blood cell counts after dental extractions?
  • Do participants exhibit hepatic and renal alterations?
  • What side effects do participants experience when taking these medications?

Researchers will compare dipyrone and paracetamol to learn more about their safety after dental extractions.

Participants will:

  • Undergo two dental extractions, one during each study period, involving teeth that already need to be removed
  • Take dipyrone 500 mg or paracetamol 750 mg in a random order, taking two capsules every 6 hours for 7 days during each period
  • Have at least 21 days between the two study periods
  • Have three blood collections: one before the first extraction and one on the eighth day after each extraction
  • Keep a diary of their pain, medication use, and possible side effects
  • Have their blood pressure checked and attend clinic visits and telephone follow-ups to monitor their health

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Dental extractions are commonly followed by pain, and medications such as dipyrone and paracetamol are used to help relieve this pain. Although both medications are widely used, it is important to better understand their safety, particularly their possible effects on blood cell counts.

This clinical trial aims to compare the safety of dipyrone and paracetamol in adults undergoing dental extractions. The main focus is to evaluate changes in blood cell counts, including white blood cells, neutrophils, red blood cells, and platelets. The study will also assess blood tests related to liver and kidney function, changes in blood pressure and possible side effects during treatment.

Participants will undergo two dental extractions, one during each study period, involving teeth that already require removal. The order in which participants receive the medications will be determined randomly. During one study period, participants will receive dipyrone 500 mg per dose, and during the other, they will receive paracetamol 750 mg per dose. Each dose will consist of two capsules. The medications will be provided in identical capsules and will be prepared by a compounding pharmacy in Brazil, according to the study protocol. Neither participants nor researchers will know which medication is being used during each period. Each treatment period will last 7 days, with two capsules taken every 6 hours, according to the study protocol. The two study periods will be separated by at least 21 days.

Blood samples will be collected three times: before the first dental extraction and on the eighth day after each extraction. These tests will allow researchers to compare blood cell counts and other laboratory results before and after each medication period. Participants will also record their pain levels, medication use, and possible side effects in a diary. Blood pressure will be monitored, and clinical assessments and telephone contacts will be used to follow participants' health and identify possible adverse reactions.

By comparing the results obtained during the two treatment periods, researchers hope to improve understanding of the safety of dipyrone and paracetamol when used after dental extractions. The findings may contribute to evidence-based decisions about pain management following dental surgery.

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Brasilien
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brasilien, 36036-900

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 60 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Healthy patients of both sexes, aged 18 to 60 years
  • Indication for bilateral tooth extraction in similar positions

Exclusion Criteria:

  • History of allergy to dipyrone or paracetamol.
  • Insufficient or improperly completed study records.
  • Failure to return for the second tooth extraction.
  • Use of warfarin, bupropion, efavirenz, methadone, cyclosporine, tacrolimus, sertraline, valproate, methotrexate, acetylsalicylic acid, or other non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, or corticosteroids on a continuous basis (for 7 days or longer) prior to surgery.
  • Systemic conditions that could interfere with hematological outcomes, including diagnosed hematological disorders, coagulopathies, severe liver or kidney disease, or active autoimmune diseases at the time of the appointment.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Arm 1: Paracetamol followed by dipyrone

Participants receive paracetamol 750 mg per dose during the first treatment period, following the first dental extraction, and dipyrone 500 mg per dose during the second treatment period, following the second dental extraction, according to the randomized crossover sequence. Each treatment is administered as two capsules every 6 hours for 7 days, with a washout period between treatments.
Arzneimittel: Dipyrone administration

Dipyrone 500 mg per dose, administered orally as two capsules every 6 hours for 7 days following dental extraction, according to the study protocol.

Arzneimittel: Paracetamol (drug)

Paracetamol 750 mg per dose, administered orally as two capsules every 6 hours for 7 days following dental extraction, according to the study protocol

Verfahren: blood sampling

Blood samples will be collected at three time points: before the first dental extraction, on the eighth day after the first treatment period, and on the eighth day after the second treatment period.
Experimental: Dipyrone followed by paracetamol

Participants receive dipyrone 500 mg per dose during the first treatment period, following the first dental extraction, and paracetamol 750 mg per dose during the second treatment period, following the second dental extraction, according to the randomized crossover sequence. Each treatment is administered as two capsules every 6 hours for 7 days, with a washout period between treatments.
Arzneimittel: Dipyrone administration

Dipyrone 500 mg per dose, administered orally as two capsules every 6 hours for 7 days following dental extraction, according to the study protocol.

Arzneimittel: Paracetamol (drug)

Paracetamol 750 mg per dose, administered orally as two capsules every 6 hours for 7 days following dental extraction, according to the study protocol

Verfahren: blood sampling

Blood samples will be collected at three time points: before the first dental extraction, on the eighth day after the first treatment period, and on the eighth day after the second treatment period.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
White Blood Cell Parameters.
Zeitfenster: Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.

Total leukocyte count and neutrophil count will be assessed through blood samples and reported as cells/mm³, to evaluate changes following treatment with dipyrone and paracetamol after dental extractions.
Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.
Hemoglobin Level.
Zeitfenster: Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.

Hemoglobin level will be assessed in blood samples, and reported as g/dL, to evaluate changes following treatment with dipyrone and paracetamol after dental extractions.
Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.
Hematocrit.
Zeitfenster: Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.

Hematocrit will be assessed in blood samples, and reported as %, to evaluate changes following treatment with dipyrone and paracetamol after dental extractions.
Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.
Platelet Count
Zeitfenster: Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.

Platelet count will be assessed in blood samples, and reported as cells/mm³, to evaluate changes following treatment with dipyrone and paracetamol after dental extractions.
Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in Liver Function Biomarkers.
Zeitfenster: Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.

Changes in aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), and alkaline phosphatase levels will be assessed through blood samples collected during the study, and reported as U/L.
Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.
Changes in Kidney Function Biomarkers.
Zeitfenster: Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.

Changes in creatinine and urea levels will be assessed through blood samples collected during the study, and reported as mg/dL.
Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.
Adverse Reactions.
Zeitfenster: Daily, from day 1 to day 7 after each dental extraction.

Occurrence of adverse reactions associated with dipyrone and paracetamol will be monitored and recorded during each postoperative treatment period.
Daily, from day 1 to day 7 after each dental extraction.
Systolic Blood Pressure
Zeitfenster: Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.

Systolic blood pressure measurements will be recorded to evaluate changes during treatment with dipyrone and paracetamol after dental extractions, and reported as mmHg
Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.
Diastolic Blood Pressure.
Zeitfenster: Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.

Diastolic blood pressure measurements will be recorded to evaluate changes during treatment with dipyrone and paracetamol after dental extractions, and reported as mmHg
Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Matheus Furtado de Carvalho

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

13. November 2026

Primärer Abschluss (Geschätzt)

31. Juli 2027

Studienabschluss (Geschätzt)

31. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

27. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. November 2026

Zuerst gepostet (Tatsächlich)

5. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. November 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 97343326.1.0000.5147

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be shared with researchers outside the study team. Data access will be restricted to authorized researchers, and participant confidentiality will be protected through data coding, password-protected digital files, and restricted access to physical documents, in accordance with applicable data protection requirements.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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