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Hematologic TestPhase 4NCT07918040

Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions

A Phase 4 study testing Dipyrone administration, Paracetamol (drug) and blood sampling in people with Hematologic Test and Agranulocytosis, run by Matheus Furtado de Carvalho at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Hematologic Test, Agranulocytosis, Side Effects
What is being tested?
Dipyrone administration, Paracetamol (drug) and blood sampling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteBrazil
Study dates
13 Nov 2026to 31 Jul 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brazil1 site, 1 recruiting
  • Faculty of Dentistry at the Federal University of Juiz de Fora (UFJF)

    Juiz de Fora, Minas Gerais, 36036-900

    Matheus F Carvalho, PhD, + 55 (32) 98811-3967, matheus.furtado@ufjf.br

    Alice F Fernandes, + 55 (32) 99863-3990, aliceferreira.fernandes@estudante.ufjf.br

    Recruiting

Other trials in Brazil

About this study

Official title: 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?
Read more

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
Read the detailed description

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.

Being tested
Dipyrone administration, Paracetamol (drug), blood sampling
Keywords
Dipyrone, Paracetamol, Hematological tests
Medical subject headings
Agranulocytosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dipyrone administrationDrug

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

  • Paracetamol (drug)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

  • blood samplingProcedure or surgery

    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.

Study groups in NCT07918040
Study groupRoleWhat they receive
Arm 1: Paracetamol followed by dipyroneExperimentalParticipants 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.
Receives: Drug: Dipyrone administration; Drug: Paracetamol (drug); Procedure: blood sampling
Dipyrone followed by paracetamolExperimentalParticipants 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.
Receives: Drug: Dipyrone administration; Drug: Paracetamol (drug); Procedure: blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. White Blood Cell Parameters.

    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.

    Measured: Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.

  2. Hemoglobin Level.

    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.

    Measured: Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.

  3. Hematocrit.

    Hematocrit will be assessed in blood samples, and reported as %, to evaluate changes following treatment with dipyrone and paracetamol after dental extractions.

    Measured: Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.

  4. Platelet Count

    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.

    Measured: Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.

Secondary outcomes (5)
  1. Changes in Liver Function Biomarkers.

    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.

    Measured: Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.

  2. Changes in Kidney Function Biomarkers.

    Changes in creatinine and urea levels will be assessed through blood samples collected during the study, and reported as mg/dL.

    Measured: Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.

  3. Adverse Reactions.

    Occurrence of adverse reactions associated with dipyrone and paracetamol will be monitored and recorded during each postoperative treatment period.

    Measured: Daily, from day 1 to day 7 after each dental extraction.

  4. Systolic Blood Pressure

    Systolic blood pressure measurements will be recorded to evaluate changes during treatment with dipyrone and paracetamol after dental extractions, and reported as mmHg

    Measured: Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.

  5. Diastolic Blood Pressure.

    Diastolic blood pressure measurements will be recorded to evaluate changes during treatment with dipyrone and paracetamol after dental extractions, and reported as mmHg

    Measured: Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2026
  2. Study start13 Nov 2026 (estimated)
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07918040
Sponsor's protocol ID
97343326.1.0000.5147
Status last verified
Oct 2026
First submitted
27 Oct 2026
Last updated
6 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Fidelis GFS, Dagli-Hernandez C, Martinelli RP, Marzuki JE, Baharuddin B, Yue QY, Edwards B, Pincinato EC, Moriel P. Pharmacogenetics of metamizole-induced agranulocytosis: a systematic review and drug regulation implications. Front Pharmacol. 2025 Sep 24;16:1624044. doi: 10.3389/fphar.2025.1624044. eCollection 2025.

    PubMed 41069600
  • Zinzi A, Gaio M, Ruggiero D, Riccardi C, Cagnotta C, Pentella C, Capuano A, Rafaniello C. A systematic review and pharmacovigilance analysis of the risk of agranulocytosis associated with metamizole use. Sci Rep. 2025 Nov 28;15(1):42796. doi: 10.1038/s41598-025-27009-6.

    PubMed 41315510
  • Tsang WH, Chan CK, Tse ML. Paracetamol-induced hepatotoxicity after normal therapeutic doses in the Hong Kong Chinese population. Hong Kong Med J. 2024 Oct;30(5):355-361. doi: 10.12809/hkmj2311194. Epub 2024 Oct 10.

    PubMed 39385704
  • Blaser LS, Duthaler U, Bouitbir J, Leuppi-Taegtmeyer AB, Liakoni E, Dolf R, Mayr M, Drewe J, Krahenbuhl S, Haschke M. Comparative Effects of Metamizole (Dipyrone) and Naproxen on Renal Function and Prostacyclin Synthesis in Salt-Depleted Healthy Subjects - A Randomized Controlled Parallel Group Study. Front Pharmacol. 2021 Sep 7;12:620635. doi: 10.3389/fphar.2021.620635. eCollection 2021.

    PubMed 34557087
  • Watkins PB, Kaplowitz N, Slattery JT, Colonese CR, Colucci SV, Stewart PW, Harris SC. Aminotransferase elevations in healthy adults receiving 4 grams of acetaminophen daily: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):87-93. doi: 10.1001/jama.296.1.87.

    PubMed 16820551
  • Risks of agranulocytosis and aplastic anemia. A first report of their relation to drug use with special reference to analgesics. The International Agranulocytosis and Aplastic Anemia Study. JAMA. 1986 Oct 3;256(13):1749-57.

    PubMed 3747087
  • ANDRADE, E. D. Terapêutica Medicamentosa em Odontologia. 2ª ed. São Paulo: Artes Médicas; 2006

  • de Souza EC, Matos DM, Viana MR, Alvim MCO, Bonfante HL, Pinto AF, Nascimento JWL. Evaluation of hematological alterations after therapeutic use of dipyrone in healthy adults: a prospective study. J Basic Clin Physiol Pharmacol. 2018 Jul 26;29(4):385-390. doi: 10.1515/jbcpp-2017-0037.

    PubMed 29432206

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dipyrone administration, Paracetamol (drug) and blood sampling in people with Hematologic Test and Agranulocytosis, run by Matheus Furtado de Carvalho at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

White Blood Cell Parameters. (time frame: Before the first dental extraction, day 8 after the first dental extraction, and day 8 after the second dental extraction.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07918040, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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