A RANDOMISED CONTROLLED STUDY TO EVALUATE THE EFFICACY OF ORAL MIDAZOLAM SYRUP AND INTRANASAL MIDAZOLAM SPRAY AS IDEAL PREMEDICANT IN CHILDREN UNDERGOING DIFFERENT TYPES OF SURGERIES

Abstract

Girish K. N1, Nikhil Anish2

INTRODUCTION: Most of the preschool children suffer from severe anxiety and apprehension before surgery. This can largely affect the smooth conductance and emergence from anaesthesia, with complications such as bronchospasm at the time of induction and emergence phenomenon at the end. This can lead to the development of maladaptive behavioral responses or posttraumatic stress disorders in later part of life. Midazolam in current time has emerged as an ideal premedicant having all the desirable properties in this regard. It has been used by several routes for premedication which includes oral and intranasal administration as most frequently used route. Each has its own advantage and disadvantage. The search for an ideal route and dose still exists. So the current study was planned to find out the efficacy of midazolam intranasally & orally. Midazolam is a benzodiazepine. It is highly lipid soluble invivo. Its lipid solubility is pH dependent, being more alkaline pH. It acts by binding to GABA-A receptors. It is metabolized by cyt P450 3A4. It has anxiolytic, amnesic, sedative, hypnotic, anticonvulsant & spinally mediated muscle relaxant property. Midazolam tastes bitter, so flavored midazolam syrup is available and its efficacy remains almost same and acceptability increases. The Midazolam nasal spray is also available.
MATERIALS & METHODS: Aim of study was to evaluate the efficacy of oral midazolam syrup (0.25mg/kg) vs intranasal midazolam spray (0.3mg/kg) as ideal permedicant in children (3-10 yrs) undergoing various types of surgeries. After obtaining institutional ethical committee approval, 50 children belonging to ASA grade I & II aged between 3-10 yrs posted for elective surgeries were randomly taken for the study. Informed & written consent was obtained from the parents regarding the study. These 50 children were randomly divided into 2 groups, each comprising 25. Group 1, OM group was given oral midazolam. Group 2, NM group was given nasal midazolam. Patients (ASA class I–II) scheduled for elective surgical procedures were candidates for study.
Exclusion criteria included gastrointestinal disorders that might affect absorption, nasal polyps, nasal trauma and any medical condition that could compromise the safety of the patient or interfere with the interpretation of the results. Because midazolam is a known substrate of the cytochrome P450 3A4 enzyme system, patients taking known cytochrome P450 3A4 inhibitors or inducers were excluded. The independent variable in the study was the choice of drug route (oral or intranasal). The dependent variables in assessment of the effectiveness of each route were the sedation level, respiratory & haemodynamic parameters.

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