Abstract
Background and Objectives: A novel lozenge formulation with advantages of ease of drug administration, palatable taste and improved patient compliance could be the preferred mode of topical pharyngeal anesthesia during upper gastrointestinal endoscopy (UGE). This randomized, open-label, active-controlled study was conducted to evaluate the efficacy and safety of lidocaine lozenges versus lidocaine spray in the diagnostic gastroduodenal endoscopy in Indian patients. Subjects and Methods: Two hundred and forty-seven patients of either sex (18-80 years) undergoing diagnostic gastroduodenal endoscopy were randomized either to; lidocaine lozenge 200 mg or lidocaine spray 200 mg to be applied as a single dose before gastroduodenal endoscopy. Ease of procedure, level of gag reflex, ease of application of the local anesthetic, and investigators global assessment were the primary efficacy endpoints. Need for rescue medication and patient’s global assessment were secondary efficacy endpoints. The incidence of any adverse event was the safety endpoint. Between groups, comparison was done by using appropriate statistical test. Results: Investigator reported significantly lesser procedural difficulty (P = 0.0007) and suppressed gag reflex (P < 0.0001) during UGE with lidocaine lozenge compared to spray. Ease of application of local anesthetic was reported easy in significantly more patients as compared with lidocaine spray (P = 0.001). Global assessment by patient and physician was favorable toward lozenge. Incidences of adverse events were similar in both the groups. Conclusions: The study suggests that lidocaine lozenges are an easier way of applying local oropharyngeal anesthesia, produces better suppression of gag reflex and makes the procedure easier when compared with lidocaine spray.
Antiperistaltic effect and safety of
l
‐menthol oral solution on gastric mucosa for upper gastrointestinal endoscopy in Chinese patients: Phase III, multicenter, randomized, double‐blind, placebo‐controlled study