Fixed Combination of Dipirone and Codeine Compared to the Isolated Use of Dipyrone and Codeine in Controlling Pain After Pelvic-abdominal Surgery.

Last updated: June 25, 2024
Sponsor: Brazilian Clinical Research Institute
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

Codeine

Dipyrone

Fixed dose combination Dipyrone and Codeine

Clinical Study ID

NCT04641338
03/2020
  • Ages > 18
  • All Genders

Study Summary

Phase III clinical trial, multicentre of superiority, randomized, open, parallel groups, with active control and use of postoperative oral medication (multiple doses of medication).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥ 18 years;

  • Patients in the 1st postoperative period of open abdominal or pelvic surgery (last 24 hours) and receiving short duration analgesics or opioids in any route ofadministration on the previous day, being able to receive oral medication andscheduled home discharge in hours or days, with pain moderate to intense intensity (defined as VAS pain ≥ 4);

  • Have signed the informed consent form.

Exclusion

Exclusion Criteria:

  • Surgical complications to the inclusion of the participant in the research;

  • Other serious comorbidities at the discretion of the investigators (such as ahistory of renal, hepatic, cardiac or other peptic ulcer);

  • History of chronic and current use of opioids or other analgesics;

  • Users of alcohol or illicit drugs;

  • Use of drugs with the potential to interact with study drugs;

  • Allergy, hypersensitivity or known contraindication to the use of components of thestudy drug;

  • Psychiatric or social disorders that prevent adequate follow-up to the protocol;

  • Show inability to understand and perform current pain assessments in the study;

  • Women of childbearing potential, defined as all physiologically capable women ofchildbearing, unless they are using effective contraceptive methods whileadministering study medication;

  • Any clinical condition that the investigator considers to generate risk to thepatient or interfere with the conduct of the study;

  • Participation in another clinical study in less than a year (unless participation bythe principal investigator is justified).

Study Design

Total Participants: 491
Treatment Group(s): 3
Primary Treatment: Codeine
Phase: 3
Study Start date:
March 16, 2023
Estimated Completion Date:
May 17, 2024

Study Description

The main objective is to evaluate the effectiveness and safety of the association in relation to the isolated use of medicines.

Connect with a study center

  • Associação Hospital de Caridade Ijuí - Núcleo de Ensino e Pesquisa

    Ijuí, Rio Grande Do Sul
    Brazil

    Site Not Available

  • Hospital Universitário São Francisco na Providência de Deus

    Bragança Paulista, São Paulo
    Brazil

    Site Not Available

  • Santa Casa de Misericórdia de Votuporanga

    Votuporanga, São Paulo
    Brazil

    Site Not Available

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