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

NCT04641338 | Completed Phase 3 DMC

• 1 other identifier: 03/2020
• Study Type: interventional
• Target: 491
• Locations: 1 country
• Sites: 3

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).

Conditions

Pain, Postoperative

Keywords

Dipirone; Codeine; pain

Outcome Measures

Primary Outcomes (1)

• Average of sum of the pain difference

  The primary endpoint of the study is the average sum of the pain difference after study medication compared to the baseline by visual analogic scale from 0 to 10 cm, where 0 = no pain, and 10 = the worst imaginable pain)

  During hospitalization (around 48 hours post surgical procedure)

Secondary Outcomes (6)

• Average of visual analogic scale score

  During hospitalization (around 48 hours post surgical procedure)

• VRS (verbal scale and relief assessment pain)

  During hospitalization (around 48 hours post surgical procedure)

• Assessment of complete pain relief by verbal scale and relief assessment pain (VRS)

  During hospitalization (around 48 hours post surgical procedure)

• Need for medication of rescue

  During hospitalization (around 48 hours post surgical procedure)

• Assessment of satisfaction with treatment by the participant

  14 days

Study Arms (2)

Intervention group

EXPERIMENTAL

Drug: Fixed dose combination Dipyrone and Codeine

Control group

ACTIVE COMPARATOR

Drug: Dipyrone; Drug: Codeine

Interventions

Fixed dose combination Dipyrone and Codeine DRUG

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

Intervention group

Dipyrone DRUG

use of 1000 mg dipyrone every 6 hours if necessary.

Control group

Codeine DRUG

30 mg codeine every 6 hours if necessary.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Brazilian Clinical Research Institute: lead
• Brainfarma Industria Química e Farmacêutica S/A: collaborator

Study Sites (3)

Associação Hospital de Caridade Ijuí - Núcleo de Ensino e Pesquisa

Ijuí, Rio Grande do Sul, Brazil

Location

Hospital Universitário São Francisco na Providência de Deus

Bragança Paulista, São Paulo, Brazil

Location

Santa Casa de Misericórdia de Votuporanga

Votuporanga, São Paulo, Brazil

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Codeine; Dipyrone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: November 23, 2020
• Study Start: March 16, 2023
• Primary Completion: March 15, 2024
• Study Completion: May 17, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

BR (3)