Estudo clínico randomizado e aberto para avaliação de eficácia e superioridade dos medicamentos EF028 aerossol, EF028 creme e Andolba® frente ao tratamento controle e comparativo de não inferioridade entre os medicamentos EF028 aerossol, EF028 creme e Andolba® para avaliação de eficácia na redução da sintomatologia dolorosa

Abstract

Aim: This study aimed to evaluate the efficacy of a new topical drug (EF028) in two separate presentations (aerosol and cream) in a comparative way with the already registered medication, Andolba® (benzocaine, benzoxiquina chloride benzeconio, menthol) and the negative control (hygiene), in the analgesic efficacy after episiotomy wound, reducing the requirement for systemic medication. Methods: 60 patients were voluntary post normal vaginal childbirth with episiotomy, were divided into four groups to comparatively assess the action of the product EF028 (cream and aerosol), Andolba® and soap, the efficacy of decreasing painful symptoms from daily use for 2 times a day for seven days. Clinical assessments and subjective pain occurred daily until the third postoperative day and on the 7th postoperative day. Results: The results showed that the drugs promoted a reduction of painful symptoms and there was no statistically significant difference (p <0.05) between presentations of drug EF028 (cream and aerosol) and Andolba® and the three products were significantly higher (p <0.05) to the control. Conclusions: The evaluated drugs EF028 aerosol, EF028 cream and Andolba® had similar efficacy in relieving the painful symptoms of the perineal region in postoperative episiotomy can be considered as indication for postoperative episiotomies. © Copyright Moreira Jr. Editora.