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

Randomized, Open, Multicentre, National Superiority Clinical Trial to Assess the Combination of Fixed Dosage of Dipyrone and Codeine Compared to the Isolated Use of Components in the Control of Moderate to Severe Pain After Open Pelvic-abdominal Surgery.

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

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Fixed dose combination Dipyrone and Codeine; Drug: Dipyrone; Drug: Codeine

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 328
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Brainfarma Indústria Química Farmacêutica; Phone Number: 5511 45072111; Email: juliana.augusto@brainfarma.ind.br

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Ijuí, Rio Grande Do Sul, Brazil
      • Recruiting
      • Associação Hospital de Caridade Ijuí - Núcleo de Ensino e Pesquisa
      • Contact: Fernando Vargas Bueno, MD
  • São Paulo
    • Bragança Paulista, São Paulo, Brazil
      • Recruiting
      • Hospital Universitario Sao Francisco na Providencia de Deus
      • Contact: Ciro Carneiro Medeiros, MD
    • Votuporanga, São Paulo, Brazil
      • Recruiting
      • Santa Casa de Misericórdia de Votuporanga
      • Contact: Juliana Meziara, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group	Drug: Fixed dose combination Dipyrone and Codeine; Fixed dose combination: dipyrone 1000 mg + codeine 30 mg every 6 hours if necessary.
Active Comparator: Control group	Drug: Dipyrone; use of 1000 mg dipyrone every 6 hours if necessary.; Drug: Codeine; 30 mg codeine every 6 hours if necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average of visual analogic scale score	The average visual analogic scale score (visual analogic scale from 0 to 10 cm, where 0 = no pain and 10 = the worst imaginable pain) measured at rest and during handling in subsequent medication.	During hospitalization (around 48 hours post surgical procedure)
VRS (verbal scale and relief assessment pain)	VRS (verbal scale and relief assessment pain) where 0 = no pain relief, 1 = mild pain relief, 2 = moderate pain relief, 3 = good pain relief and 4 = excellent pain relief)	During hospitalization (around 48 hours post surgical procedure)
Assessment of complete pain relief by verbal scale and relief assessment pain (VRS)	Assessment of complete pain relief by verbal scale assessment of pain relief (VRS where 0 = no pain relief, 1 = mild pain relief, 2 = moderate pain relief, 3 = good pain relief, and 4 = excellent pain relief).	During hospitalization (around 48 hours post surgical procedure)
Need for medication of rescue	Number of patients who need medication of rescue (Patients who did not experience adequate pain relief with study medication who use additional analgesics, ie, rescue medication).	During hospitalization (around 48 hours post surgical procedure)
Assessment of satisfaction with treatment by the participant	Assessment of satisfaction with treatment by the participant using a standard categorical rating scale: Patient-reported global evaluation of Eficacy (PGE) scale of 5-points where 0=poor, 1=fair, 2=good , 3=very good, and 5=excellent response to therapy).	14 days
Presence of adverse events		14 days

Collaborators and Investigators

• Sponsor: Brazilian Clinical Research Institute
• Collaborators: Brainfarma Industria Química e Farmacêutica S/A

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: pain; Codeine; Dipirone
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antipyretics; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Codeine; Dipyrone
• Other Study ID Numbers: 03/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No