Effects of benzydamine hydrochloride on postoperative sore throat after extubation in children: A randomized controlled trial

Abstract

Background: Postoperative sore throat (POST) is a common, undesirable result of endotracheal intubation during general anaesthesia. This study aimed to evaluate the effectiveness of benzydamine hydrochloride (BH) spray in reducing the incidence of POST in paediatric patients. Methods: This randomized, double-blind, prospective study included 142 children 6-12 years of age, who were randomly assigned to receive either BH spray or control. After induction of anaesthesia, direct laryngoscope was placed and BH spray was applied to the upper trachea and vocal cord in the BH group and intubation was performed using a cuffed tube lubricated with normal saline. Intubation in the control group was performed using a cuffed tube lubricated with normal saline without any intervention. The balloon was inflated to a pressure of 20 cmH2O. Patients were extubated after fully awakened and transferred to the post-anaesthetic care unit (PACU), where they were examined for the presence of POST and any adverse events 30 min after arrival to the PACU. Postoperative pain was evaluated using a smartphone application. Results: Seventy-one patients were allocated to each group. The incidence of POST in the BH group did not differ from that in the control group (control: BH = 35 (49.3%): 42 (59.2%); P = 0.238); postoperative pain was also similar between the groups. Other complications, such as breath holding, secretions, coughing, laryngospasm and desaturation events, did not differ between the groups. Conclusions: Application of prophylactic BH spray to the vocal cords and upper trachea was not proven to reduce POST in paediatric patients. Trial registry: NCT03074968 (ClinicalTrials.gov, Feb 26, 2017).