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Effects of Benzydamine Hydrochloride on Postoperative Sore Throat After

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Effects of Benzydamine Hydrochloride on Postoperative Sore Throat After Yhim et al. BMC Anesthesiology (2020) 20:77 https://doi.org/10.1186/s12871-020-00995-y RESEARCH ARTICLE Open Access Effects of benzydamine hydrochloride on postoperative sore throat after extubation in children: a randomized controlled trial Hyung-Been Yhim1 ,Soo-HyukYoon1 , Young-Eun Jang1 , Ji-Hyun Lee1 , Eun-Hee Kim1 , Jin-Tae Kim1,2 and Hee-Soo Kim1,2* 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). Keywords: Benzydamine hydrochloride, Children, Postoperative sore throat * Correspondence: [email protected] 1Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, #101 Daehakno, Jongnogu, Seoul 03080, Korea 2Department of Anesthesiology and Pain Medicine, College of Medicine, Seoul National University, #101 Daehak-ro, Jongno-gu, 03080 Seoul, Republic of Korea © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Yhim et al. BMC Anesthesiology (2020) 20:77 Page 2 of 8 Background Methods One of the most common side effects following endo- Patient recruitment tracheal intubation is postoperative sore throat (POST). A prospective, randomised, comparative study was con- The overall incidence of POST in the adult population ducted between March and June 2017 at Seoul National varies from 22 to 62% [1–3], and that in paediatric University Hospital (SNUH, Seoul, Korea). The study population has been observed ranging from 24 to 44% was approved by the SNUH Institutional Review Board [2, 4]. Some reported POST to occur at a peak incidence (1612–061-813) and was registered at ClinicalTrials.gov of 2 to 4 h after extubation in adult population whereas (NCT03074968, Feb 26, 2017, https://register.clinical- only limited publications regarding the incidence or peak trials.gov/prs/app/template/EditProtocol.vm?listmode= time of POST were found among paediatric population Edit&uid=U0000Y58&ts=5&sid=S0006WDR&cx=-hdb51 [2, 5]. Several publications evaluated POST in children u). Each participant and corresponding parent were as early as 15 min since POST is worse in the early post- given a verbal explanation with an opportunity to ask operative period, then decreases over time [6]. Although questions about the study. Written informed consent POST is usually alleviated over time, it lingers for 12 to was obtained from participants ≥7 years of age and their 24 h, which results in significant dissatisfactions postop- parents. Verbal assent was obtained from participants < eratively [4]. 7 years of age, in addition to written informed consent POST is induced by direct mucosal inflammation from their parents. All procedures adhered to the princi- caused by mechanical trauma with endotracheal intub- ples of the Declaration of Helsinki. ation [7]. The known risk factors for POST are presence A total of 150 children 6–12 years of age were of upper respiratory tract infection, duration of anaes- screened, of whom 144 were ultimately enrolled. All thesia, intubation without neuromuscular blockers, the were classified as American Society of Anaesthesiologists number of intubation attempts, high cuff pressure, and (ASA) physical status I-II and scheduled for elective sur- the operator’s experience [2]. In particular, the use of gery under general anaesthesia with endotracheal tube uncuffed-endotracheal tubes and higher cuff pressure of intubation. Individuals with intellectual disabilities, his- cuffed-endotracheal tube were identified as main risk tory of preoperative sore throat, recent upper respiratory factors for POST in children [3, 4]. infection, history of difficult or expected difficult airway, Several systemic reviews have suggested the use of pre- were excluded. In specific, difficult airway was defined as emptive local anaesthetics or anti-inflammatory drugs, Cormack-Lehane class 3 or 4 by laryngoscopy, and ≥ 2 such as benzydamine hydrochloride (BH), [8]lidocaine, intubation attempts. Those who required postoperative [5, 9]ketamine,[5, 10]aspirin,[11] and dexpanthenol [12] mechanical ventilation were also excluded. Another ex- for the prevention of POST. BH is a topical nonsteroidal clusion was made depending on the type of the surgery. anti-inflammatory drug with additional analgesic and anti- Ear-Nose-Throat (ENT) surgeries were limited to those pyretic properties easily applicable to children [13]. BH is not involving the airway. ENT surgeries were included available in both topical and systemic formulations; how- only when the surgical target was limited to ear, such as ever, due to its high volume of distribution, along with its myringotomy, myringoplasty, or canal wall mastoidec- low systemic clearance, BH is preferably used topically as tomy. Any surgery that invaded oropharynx, or required an oral spray, mouthwash, or vaginal administration [13]. gastric tube insertion was not enrolled as well. When topically absorbed, BH demonstrated low bioavail- Children were prospectively screened and randomly al- ability with 5% or less and late peak plasma concentration located into one of the following two groups using a occurring more than 24 h after application. This temporal randomization table (online randomization software; residence at mucosal area benefits in treating soft tissue http://www.randomisation.com): control group, and BH injury and mitigating any systemic side effects such as group. Children were enrolled by one of the investiga- numbness, tingling sense of oral cavity, cough, and dry tors, while another independent investigator generated mouth [13]. Especially in alleviating POST, different top- the random allocation sequence, prepared sealed opaque ical application methods have been used, such as direct envelopes, opened the envelope immediately before the spraying at the oropharyngeal cavity, gargling, spraying start of anaesthesia, and assigned participants to their re- the endotracheal tube cuff, lubricating at the endotracheal spective study group. cuff, or in combination at both the cuff and oropharyngeal cavity [14–16]. To the best of our knowledge, there have Anaesthetic methods been no clinical trials comparing the effects of BH on All patients arrived at the operating room without pre- POST in targeting a specific population of children. medication and appropriately fasted according to prac- In this study, we aimed to evaluate whether spraying tice guidelines from the ASA. Peripheral pulse oximetry BH along the oropharyngeal space before intubation re- (i.e., oxygen saturation [SpO2]), non-invasive blood pres- duced POST in children. sure (NIBP) at 1-min intervals, and electrocardiography Yhim et al. BMC Anesthesiology (2020) 20:77 Page 3 of 8 were monitored. N2O-free general anaesthesia was in- 15 mg/kg of propacetamol was administered for postop- duced with 2–2.5 mg/kg of propofol after the 0.5 mg erative pain control. The distinction between these two − kg 1 of 1% lidocaine administration. After loss of con- different postoperative analgesic
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