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NCT07918040
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Conditions: Hematologic Test, Agranulocytosis, Side Effects, Blood Pressure Monitoring, Hepatic Complications, Renal Effects
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 50
Sponsor: Matheus Furtado de Carvalho
Location: Faculty of Dentistry at the Federal University of Juiz de Fora (UFJF) Juiz de Fora Minas Gerais
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
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07918040). StuddyBuddy aggregates publicly available trial information.