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

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

Official Title
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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.

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Fixed dose combination Dipyrone and Codeine
* Drug: Dipyrone
* Drug: Codeine


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, Dipirone, Codeine