Pain, Postoperative
Conditions
Keywords
Dipirone, Codeine, pain
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.
Interventions
Sponsors
Brainfarma Industria Química e Farmacêutica S/A
Brazilian Clinical Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average of sum of the pain difference | During hospitalization (around 48 hours post surgical procedure) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VRS (verbal scale and relief assessment pain) | During hospitalization (around 48 hours post surgical procedure) | 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) |
| Assessment of complete pain relief by verbal scale and relief assessment pain (VRS) | During hospitalization (around 48 hours post surgical procedure) | 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). |
| Average of visual analogic scale score | During hospitalization (around 48 hours post surgical procedure) | 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. |
| 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 | — |
| Need for medication of rescue | During hospitalization (around 48 hours post surgical procedure) | 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). |
Countries
Brazil
Outcome results
None listed