Fixed Combination of Dipyrone and Codeine for 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, superiority, randomized, open, parallel groups, with active control and use of postoperative oral medication (multiple doses of medication).

Conditions

Pain, Postoperative

Keywords

Codeine; pain; Dipyrone

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving at least 50% of maximum pain relief within 6 hours

  Proportion of participants achieving at least 50% of maximum pain relief within 6 hours after first drug administration, through the assessment of total pain relief (TOTPAR) after first drug administration. TOTPAR is calculated from the result of the 5-point categorical pain relief scale (adapted PAR scale, with the 5 categories: 1-no relief, 2-mild relief, 3-moderate relief, 4-a lot of relief, and 5-complete relief). The PAR will be evaluated 30 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours after drug administration, so that the TOTPAR can take into account the progress of pain relief at 8 different timepoints.

  6 hours

Secondary Outcomes (6)

• Pain assessment by the visual analogic scale score

  6 hours

• Proportion of participants who achieve at least 50% pain reduction

  6 hours

• Assessment of complete pain relief

  72 hours

• Time to pain relief

  During hospitalization

• Assessment of satisfaction with treatment by the participant

  14 days

Study Arms (3)

Combination therapy group

EXPERIMENTAL

Drug: Fixed dose combination Dipyrone and Codeine

Dipyrone

ACTIVE COMPARATOR

Drug: Dipyrone

Codeine

ACTIVE COMPARATOR

Drug: Codeine

Interventions

Fixed dose combination Dipyrone and Codeine DRUG

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

Combination therapy group

Dipyrone DRUG

use of 1000 mg dipyrone every 6 hours

Dipyrone

Codeine DRUG

30 mg codeine every 6 hours.

Codeine

Eligibility Criteria

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

You may qualify if:

• Men or women aged 18 years or older;
• Be able to sign the ICF approved by the IEC and to perform and understand all the study procedures and instructions;
• Show post-anesthesia recovery with a score greater than or equal to 8 on the modified Aldrete and Kroulik Scale;
• Experience pain intensity according to the visual analogue scale (VAS) of 3.0 to 10 cm (moderate to severe pain) immediately after surgery;
• Have an elective open abdominal-pelvic surgery scheduled, not due to malignant neoplasm, to be performed within 4 weeks of screening;
• Estimated hospital stay for at least 48 hours after the procedure.

You may not qualify if:

• Surgical complications during participant enrollment in the research;
• Surgery with indication for treatment of confirmed or suspected malignant neoplasm;
• Chronic use of any non-steroidal anti-inflammatory drugs;
• Suspected paralytic ileus or intestinal obstruction;
• Inability to use oral drugs postoperatively;
• Videolaparoscopic surgery;
• History of chronic and current use of opioids or other analgesics;
• Use of concomitant modalities of intravenous or neuraxial analgesia (spinal and epidural) with placement of an epidural catheter for use in the postoperative period, or regional blockade, where the expected duration of analgesia administered intravenously or neuroaxially is maintained after 24 hours of the surgical procedure or randomization, whichever occurs first;
• Use of immunosuppressive therapy in the last 24 hours prior to surgery;
• Participants with uncontrollable vomiting present in the postoperative period;
• Abusive user of alcohol or illicit drugs;
• Use of drugs with potential interaction with the study drugs;
• Allergy, hypersensitivity, or known contraindication to the use of ingredients of the study drug;
• Psychiatric or social disorders that prevent the appropriate compliance with the protocol;
• Demonstrate inability to understand and perform current pain assessments in the study;

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: DOUBLE
• Who Masked: PARTICIPANT, 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: May 11, 2026

Record last verified: 2026-05

Locations

BR (3)