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Year : 2013  |  Volume : 3  |  Issue : 2  |  Page : 52-56

Lidocaine lozenge versus lidocaine spray as topical anesthesia before direct awake laryngoscopy: A randomized active controlled trial

1 Delhi ENT Hospital and Research Centre, New Delhi, India
2 Department of ENT, KIMS Hospital, Bengaluru, Karnataka, India
3 Department of medical services, Troikaa Pharmaceuticals Limited, Ahmedabad, India
4 Chairman and Managing Director, Troikaa Pharmaceuticals Limited, India

Correspondence Address:
Vipul I Prajapati
Department of Medical Services, Troikaa Pharmaceuticals Limited, Commerce House 1, Opposite Rajvansh Apartment, Satya Marg, Bodakdev, Ahmedabad - 380 054, Gujarat
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Source of Support: Troikaa Pharmaceuticals Limited, Conflict of Interest: The study is sponsored by Troikaa Pharmaceuticals Ltd. and some of the authors are in the management / payroll of the company.

DOI: 10.4103/2230-9748.132047

Clinical trial registration CTRI/2011/091/000155

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Context: Key to successful awake direct laryngoscopy is establishing reliable local anesthesia. Lidocaine spray was reported to be effective in laryngoscopic procedure with less hemodynamic and cardiovascular disturbances. Novel formulation of lidocaine as lozenges was developed to avoid problems of throat irritation and bitter taste associated with spray. Aims: The aim of the following study is to compare the efficacy and safety of lidocaine lozenges versus lidocaine spray in patients undergoing awake diagnostic direct laryngoscopy. Design: A prospective, randomized, open label, active controlled, multicentric study. Subjects and Methods: Patients of either sex, aged between 18 to 80 years and undergoing awake diagnostic direct laryngoscopy were enrolled after screening for eligibility criteria. Enrolled patients were randomized to one of the two treatment; lidocaine lozenges 200 mg and lidocaine spray 200 mg to be applied as a single dose before laryngoscopy. Immediately after the procedure, efficacy, and safety was assessed. Statistical Analysis: Between groups comparison was done using appropriate parametric or nonparametric tests. Results: Investigator experienced significantly lesser procedural difficulty and reduced gag reflex during the procedure with lidocaine lozenges compared to spray. Lesser number of patients experienced aversive symptoms (especially nausea, vomiting, cough, and pain) during and after the procedure and significantly more number of patients preferred to have a repeat procedure with lidocaine lozenges compared to spray. The global assessments by the patient and investigator favored lidocaine lozenges over spray. Conclusion: Lidocaine lozenges given before direct awake laryngoscopy provide a significant benefit by offering a more effective, safe, and convenient anesthesia compared to spray.

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