A prospective, randomized, double blind, placebo controlled clinical trial to study efficacy and safety of benzydamine 0.15% gargles in prevention of postoperative sore throat
DOI:
https://doi.org/10.18203/2320-6012.ijrms20161825Keywords:
POST, Benzydamine, Post-extubation, Sore throat, Cough, Hoarseness of voiceAbstract
Background: Postoperative sore throat (POST) is an undesirable outcome of general anesthesia. The aim of the study was to evaluate the effectiveness of benzydamine preoperative gargles in reducing the incidence and severity of POST.
Methods: A randomized double blind prospective study involving 200 adult male and female patients was performed to assess the incidence of sore throat, cough and hoarseness of voice following tracheal intubation. The patients were randomly divided into two groups (group B and group C) of 100 each. Group B patients received benzydamine 0.15% gargles while group C received placebo. Patients were asked to gargle for 30 seconds, five minutes before induction of anesthesia. The patients were examined for sore throat, cough and hoarseness of voice at intervals of 0, 2, 4, and 24 hours post-extubation.
Results: The incidence of POST was significantly high (p<0.05) in the group C (controls) as compared to group B (cases) at all the durations of time after extubation. The peak incidence was noted at 0 and 2 hours post extubation, in both the groups, where 89% in group C and 47% reports of sore throat in group B were observed. The benzydamine group B had no evidence of sore throat at 24 hours duration whereas group C had 36% of patients who still complained sore throat. The incidence and severity of hoarseness of voice was found to be significantly low in group B at all the times as compared to group C (p<0.05).
Conclusions: A simple technique of gargling performed preoperatively with benzydamine hydrochloride was effective in reducing POST with no evidence of any side effects.
References
Christensen AM, Willemoes-Larsen H, Lundby L, Jakobsen KB. Postoperative throat complaints after tracheal intubation. British Journal of Anaesthesia 1994;73:786-7.
Domino KB, Posner KL, Caplan RA, Cheney FW. Airway injury during anesthesia: a closed claims analysis. Anesthesiology. 1999;91:1703-11.
Epstein JB, Silverman S Jr., Paggiarino DA, Crockett S, Schubert MM, Senzer NN, et al. Benzydamine hydrochloride for prophylaxis of radiation induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial. Cancer. 2001;92:875-85.
Kati I, Tekin M, Silay E, Huseyinoglu UA, Yildiz H. Does benzydamine hydrochloride applied preemptively reduce sore throat due to laryngeal mask airway? Anesth Analg. 2004;99:710-2.
Conway CM, Miller JS, Sugden FLH. Sore throat after anaesthesia. British Journal of Anaesthesia. 1960;32:219-23.
Stout DM, Bishop MJ, Dwersteg JF, Cullen BF. Correlation of endotracheal tube size with sore throat and hoarseness following general anaesthesia. Anesthesiology. 1987;67:419-21.
Loeser EA, Bennett GM, Orr DL, Stanley TH. Reduction of postoperative sore throat with new endotracheal tube cuffs. Anesthesiology. 1980;52:257-9.
Loeser EA, Kaminsky A, Diaz A, Stanley TH, Pace NL. The influence of endotracheal tube cuff design and cuff lubrication on postoperative sore throat. Anesthesiology. 1983;58:376-9.
Loeser EA, Machin R, Colley J, Orr D, Bennet GM, Stanley TH. Postoperative sore throat - importance of endotracheal tube conformity versus cuff design. Anesthesiology. 1978;49:430-2.
Loeser EA, Orr DL, Bennett GM, Stanley TH. Endotracheal tube cuff design and postoperative sore throat. Anesthesiology. 1976;45:684-7.
Loeser EA, Hodges M, Gliedman J, Stanley TH, Johansen RK, Yonetani D. Tracheal pathology following short term intubation with low and high pressure endotracheal tube cuffs. Anesthesia and Analgesia. 1978;57:577-9.
Seegobin RD, van Hasselt GL. Aspiration beyond endotracheal cuffs. Canadian Anaesthetists’ Society Journal. 1986;33:273-9.
Seegobin RD, Van Hasselt GL. Endotracheal cuff pressure and tracheal mucosal blood flow: endoscopic study of effects of four large volume cuffs. BMJ. 1984;288:965-8.
Loeser EA, Stanley TH, Jordan W, Machin R. Postoperative sore throat:influence of tracheal tube lubrication versus cuff design. Canadian Anaesthetists’ Society Journal. 1980;27:156-8.
Stride PC. Postoperative sore throat: topical hydrocortisone. Anaesthesia. 1990;45:968-71.
Agarwal A, Nath SS, Goswami D, Gupta D, Dhiraaj S, Singh PK. An evaluation of the efficacy of aspirin and benzydamine hydrochloride gargle for attenuating postoperative sore throat: a prospective randomized, single-blind study. Anesth Analg. 2006;103:1-3.
Irwin BC, Acharya KB. A comparative study of benzydamine hydrochloride 0.15% w/v (“difflam” oral rinse) and acetyl salicylic acid as analgesics following tonsillectomy. J Int Med Res. 1984;12: 216-8.
Young JR. A comparative study benzydamine hydrochloride 0.15% w/v (“difflam” pump spray) and placebo as analgesics following tonsillectomy. Int J Tissue React. 1987;9:131-3.
Hung NK, Wu CT, Chan SM, Lu CH, Huang YS, Yeh CC, et al. The effect on postoperative sore throat of spraying the endotracheal tube cuff with benzydamine hydrochloride, 10% lidocaine, and 2% lidocaine. Anesth Analg. 2010;111:882-6.
Huang YS, Hung NK, Lee MS, Kuo CP, Yu JC, Huang GS, et al. The effectiveness of benzydamine hydrochloride spray on the endotracheal tube cuff or oral mucosa for postoperative sore throat. Anesthesia Analg. 2010;111:887-91.
Chien-Yu C, Kuo C, Lee Y, Lam F, Tam K. Benzydamine hydrochloride on postoperative sore throat: a meta-analysis of randomized controlled trials. Can J Anesth. 2014;61:220-8.
