Phase III clinical trial, multicentre of superiority, randomized, open, parallel groups, with active control and use of postoperative oral medication (multiple doses of medication).
The main objective is to evaluate the effectiveness and safety of the association in relation to the isolated use of medicines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
491
Associação Hospital de Caridade Ijuí - Núcleo de Ensino e Pesquisa
Ijuí, Rio Grande do Sul, Brazil
Hospital Universitário São Francisco na Providência de Deus
Bragança Paulista, São Paulo, Brazil
Santa Casa de Misericórdia de Votuporanga
Votuporanga, São Paulo, Brazil
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)
Time frame: During hospitalization (around 48 hours post surgical procedure)
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.
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: During hospitalization (around 48 hours post surgical procedure)
Assessment of satisfaction with treatment by the participant
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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).
Time frame: 14 days
Presence of adverse events
Time frame: 14 days