Clinical trial NCT04641338: Fixed Combination of Dipirone and Codeine Compared to the Isolated Use of Dipyrone and Codeine in Controlling Pain After Pelvic-abdominal Surgery.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: Dipirone
Codeine
pain
Lead sponsor: Brazilian Clinical Research Institute
Sponsor class: OTHER
Collaborators: name: Brainfarma Industria Química e Farmacêutica S/A
First posted: 2020-11-23
Enrollment: 491
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Average of sum of the pain difference
timeFrame: During hospitalization (around 48 hours post surgical procedure)
Secondary outcomes:
measure: Average of visual analogic scale score
timeFrame: During hospitalization (around 48 hours post surgical procedure)
measure: VRS (verbal scale and relief assessment pain)
timeFrame: During hospitalization (around 48 hours post surgical procedure)
measure: Assessment of complete pain relief by verbal scale and relief assessment pain (VRS)
timeFrame: During hospitalization (around 48 hours post surgical procedure)
measure: Need for medication of rescue
timeFrame: During hospitalization (around 48 hours post surgical procedure)
measure: Assessment of satisfaction with treatment by the participant
timeFrame: 14 days
measure: Presence of adverse events
timeFrame: 14 days
Other outcomes:
Locations:
city: Ijuí
country: Brazil
facility: Associação Hospital de Caridade Ijuí - Núcleo de Ensino e Pesquisa
state: Rio Grande Do Sul
city: Bragança Paulista
country: Brazil
facility: Hospital Universitário São Francisco na Providência de Deus
state: São Paulo
city: Votuporanga
country: Brazil
facility: Santa Casa de Misericórdia de Votuporanga
state: São Paulo
Study officials:
References: