Phase III clinical trial, multicentre, 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
DOUBLE
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
Proportion of participants achieving at least 50% of maximum pain relief within 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.
Time frame: 6 hours
Pain assessment by the 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: 6 hours
Proportion of participants who achieve at least 50% pain reduction
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;
Time frame: 6 hours
Assessment of complete pain relief
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: 72 hours
Time to pain relief
Median time to pain relief
Time frame: During hospitalization
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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).
Time frame: 14 days
Presence of adverse events
Time frame: 14 days