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

Pain, Postoperative Clinical Trial

— DIPICOR  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04641338
• Other study ID #: 03/2020
• Status: Recruiting
• Phase: Phase 3
• Start date: March 16, 2023
• Est. completion date: July 2024

Study information

• Verified date: May 2023
• Source: Brazilian Clinical Research Institute
• Contact: Brainfarma Indústria Química Farmacêutica
• Phone: 5511 45072111
• Email: juliana.augusto[@]brainfarma.ind.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 328
• Est. completion date: July 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Fixed dose combination Dipyrone and Codeine
Fixed dose combination: dipyrone 1000 mg + codeine 30 mg every 6 hours if necessary.
• Dipyrone
use of 1000 mg dipyrone every 6 hours if necessary.
• Codeine
30 mg codeine every 6 hours if necessary.

Locations

Country	Name	City	State
Brazil	Hospital Universitário São Francisco na Providência de Deus	Bragança Paulista	São Paulo
Brazil	Associação Hospital de Caridade Ijuí - Núcleo de Ensino e Pesquisa	Ijuí	Rio Grande Do Sul
Brazil	Santa Casa de Misericórdia de Votuporanga	Votuporanga	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Brazilian Clinical Research Institute	Brainfarma Industria Química e Farmacêutica S/A

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Presence of adverse events		14 days