English

Abstract

BACKGROUND Pre-operative anxiety is common in children and its relief is an important concern for the anaesthesiologist. Oral midazolam has good sedative and anxiolytic properties. Dexmedetomidine, an alpha-2 agonist, produces sedation like natural sleep, in addition to having analgesic, anxiolytic and anaesthetic-sparing properties, making it a near ideal sedative. Alleviating this anxiety using minimally invasive and painless routes for sedative drugs is of paramount importance. The purpose of this study was to compare the sedation, child-parent separation, and mask acceptance between sublingual atomised dexmedetomidine and oral midazolam, along with the haemodynamic changes associated with these drugs. METHODS This prospective, double-blind, randomised control trial was conducted in a tertiary hospital setting. Using computer-generated randomisation, sixty paediatric patients were divided into one of two groups. Group - D received sublingual dexmedetomidine 1.5 µg/kg using a mucosal atomisation device, and Group - M, oral midazolam 0.5 mg/kg, 45 minutes before anaesthetic induction. Sedation status, child-parent separation, mask acceptance scores, haemodynamics and oxygen saturation were measured at baseline and every 15 minutes till induction. Quantitative data were compared with student’s t-test and repeated measures analysis of variance (ANOVA), and qualitative data using chi-square test. RESULTS Demographic data were comparable between the two groups. Children in Group - D were significantly more sedated (P < 0.0001), with lower heart rate at 30 and 45 minutes (P = 0.003, < 0.0001 respectively) than Group - M. However, mask acceptance score was significantly better (P = 0.007) in Group - M. Child-parent separation score was comparable. CONCLUSIONS Atomised sublingual dexmedetomidine produced significantly greater sedation and low-normal heart rate, but poorer mask acceptance than with oral midazolam. Child-parent separation was comparable. We conclude that sublingual atomised dexmedetomidine 1.5 µg/kg, is not a suitable alternative to oral midazolam 0.5 mg/kg for paediatric premedication. KEY WORDS Anaesthesia, Dexmedetomidine, Midazolam, Anti-Anxiety Agents, Premedication, Paediatric