ClinicalTrials.gg
RecruitingNCT07918040Updated Nov 6, 2026

Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions

A Phase 4 interventional study of Dipyrone administration and Paracetamol (drug) in Hematologic Test, Agranulocytosis and Side Effects, sponsored by Matheus Furtado de Carvalho. Recruiting at 1 site in Brazil. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Matheus Furtado de Carvalho · Phase 4, Interventional, and Treatment

Updated Nov 6, 2026Study documents postedNewly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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
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.

02

Conditions studied

  • Hematologic Test
  • Agranulocytosis
  • Side Effects
  • Blood Pressure Monitoring
  • Hepatic Complications
  • Renal Effects

Keywords

  • Dipyrone
  • Paracetamol
  • Hematological tests
03

In context

Lead sponsor

This is the only study on the registry with Matheus Furtado de Carvalho as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 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 diseases at the time of the appointment.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (estimated)

Study arms

  • 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.

    Drug: Dipyrone administration · Drug: Paracetamol (drug) · Procedure: blood sampling

  • 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.

    Drug: Dipyrone administration · Drug: Paracetamol (drug) · Procedure: blood sampling

Interventions

  • DrugDipyrone 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.

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

  • Procedureblood 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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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

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

07

Study locations

1 of 1 sites recruiting
  • Faculty of Dentistry at the Federal University of Juiz de Fora (UFJF)
    Juiz de Fora, Minas Gerais 36036-900, Brazil
    Recruiting
08

References and documents

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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

09

Updates

2 registry updates since Sep 25, 2026
Registered
First appeared on the registry
Nov 5, 2026
Show all 2 updates
  1. Nov 6, 2026
  2. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07918040
Lead sponsor
Matheus Furtado de Carvalho
Responsible party
Matheus Furtado de Carvalho (Principal investigator, Federal University of Juiz de Fora) — Sponsor-investigator
First posted
Nov 5, 2026
Start date
Nov 13, 2026 (estimated)
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Nov 6, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Acetaminophen

Start the discussion