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

NCT ID: NCT04641338

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 491 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-16
• Study Completion Date: 2024-05-17

Brief 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).

Detailed Description

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

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Group Type: EXPERIMENTAL

Fixed dose combination Dipyrone and Codeine

Intervention Type: DRUG

Fixed dose combination: dipyrone 1000 mg + codeine 30 mg every 6 hours if necessary.

Control group

Group Type: ACTIVE_COMPARATOR

Dipyrone

Intervention Type: DRUG

use of 1000 mg dipyrone every 6 hours if necessary.

Codeine

Intervention Type: DRUG

30 mg codeine every 6 hours if necessary.

Interventions

Fixed dose combination Dipyrone and Codeine

Fixed dose combination: dipyrone 1000 mg + codeine 30 mg every 6 hours if necessary.

Intervention Type: DRUG

Dipyrone

use of 1000 mg dipyrone every 6 hours if necessary.

Intervention Type: DRUG

Codeine

30 mg codeine every 6 hours if necessary.

Intervention Type: DRUG

Eligibility Criteria

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 of administration on the previous day, being able to receive oral medication and scheduled home discharge in hours or days, with pain moderate to intense intensity (defined as VAS pain ≥ 4);
• Have signed the informed consent form.

Exclusion Criteria

• Surgical complications to the inclusion of the participant in the research;
• Other serious comorbidities at the discretion of the investigators (such as a history 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 the study 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 of childbearing, unless they are using effective contraceptive methods while administering study medication;
• Any clinical condition that the investigator considers to generate risk to the patient or interfere with the conduct of the study;
• Participation in another clinical study in less than a year (unless participation by the principal investigator is justified).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brainfarma Industria Química e Farmacêutica S/A

INDUSTRY

Sponsor Role: collaborator

Brazilian Clinical Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Associação Hospital de Caridade Ijuí - Núcleo de Ensino e Pesquisa

Ijuí, Rio Grande do Sul, Brazil

Hospital Universitário São Francisco na Providência de Deus

Bragança Paulista, São Paulo, Brazil

Santa Casa de Misericórdia de Votuporanga

Votuporanga, São Paulo, Brazil

Countries

Brazil

Other Identifiers

03/2020

Identifier Type: -

Identifier Source: org_study_id