Pain, Postoperative
Conditions
Keywords
Codeine, pain, Dipyrone
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).
Detailed description
The main objective is to evaluate the effectiveness and safety of the association in relation to the isolated use of medicines.
Interventions
Sponsors
Brazilian Clinical Research Institute
Brainfarma Industria Química e Farmacêutica S/A
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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; * Women who are pregnant, breastfeeding, planning to become pregnant, or who have a positive urine pregnancy test. * Participants who test positive for COVID-19 (upon presentation of the test report at the time of screening or prior to randomization); * Participation in another clinical trial within less than one year (unless the participation is warranted by the principal investigator); * Presence of decompensated diabetes mellitus; * History of decompensated obstructive or restrictive respiratory disease; * Current symptoms or past history of gastrointestinal bleeding; * History of blood dyscrasia or chronic disease of any nature that contraindicates the participant's participation at the investigator's discretion; * Inability to understand and perform the pain assessments during the study; * Hypersensitivity or contraindication to the use of ingredients of the study drugs; * Grade III obesity (BMI above 40); * Presence of one or more flu-like symptoms, such as: fever, cough, dyspnea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 14 days prior to the screening or randomization visit; * Other serious comorbidities at the investigators' discretion (such as history of renal, hepatic, cardiac or other peptic ulcer); * Any clinical condition that the investigator considers to pose a risk to the patient or interfere with study conduction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving at least 50% of maximum pain relief within 6 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment by the visual analogic scale score | 6 hours | 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. |
| Proportion of participants who achieve at least 50% pain reduction | 6 hours | Assessment of the proportion of participants who achieve at least 50% pain reduction within 6 hours, through assessment of SPID (sum of the pain intensity difference) after the first dose of study drugs; |
| Assessment of complete pain relief | 72 hours | 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). |
| Time to pain relief | During hospitalization | Median time to pain relief |
| Assessment of satisfaction with treatment by the participant | 14 days | 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). |
| Presence of adverse events | 14 days | — |
Countries
Brazil
Outcome results
None listed