Background and Aims:Preoperative anxiety in children leading to postoperative negative changes and long-term behavioral problems needs better preanesthetic sedation. Across the world, midazolam is the most commonly used premedicant in pediatric patients. The fact that no single route has achieved universal acceptance for its administration suggests that each route has its own merits and demerits. This study compares oral midazolam syrup and intranasal midazolam spray as painless and needleless systems of drug administration for preanesthetic sedation in children.Material and Methods:With randomization, Group O (30 children): Received oral midazolam syrup 0.5 mg/kg and Group IN (30 children): Received intranasal midazolam spray 0.2 mg/kg. Every child was observed for acceptance of drug, response to drug administration, sedation scale, separation score, acceptance to mask, recovery score and side effects of drug. Data were analyzed using Student's t-test, standard error of the difference between two means and Chi-square test.Results:In Group O and IN, 15/30 children (50%) and 7/30 children (23%) accepted drug easily (P < 0.05); 4/22 children (18%) in Group O and 11/20 children (55%) in Group IN cried after drug administration (P < 0.05). In both the groups, sedation at 20 min after premedication (Group O [80%] 24/30 vs. Group IN [77%] 23/30), parental separation and acceptance to mask were comparable (P > 0.05); 12/30 children (40%) in Group IN showed transient nasal irritation.Conclusion:Oral midazolam and intranasal midazolam spray produce similar anxiolysis and sedation, but acceptance of drug and response to drug administration is better with oral route.
BACKGROUND: Preoperative anxiety and long-term behavioural problems are inevitable consequences in absence of preoperative sedation in paediatric patients undergoing surgery. An ideal premedicant removes fear and anxiety in tender minds of children and achieves a calm, sedated child for smooth induction of anaesthesia and rapid recovery in postoperative period. Midazolam is the most commonly used premedicant in children as it satisfies most of the criteria of ideal premedicant but its route of administration is a debatable issue in anaesthesia practice. AIMS: This study evaluated the efficacy of atomized intranasal midazolam spray as a painless, userfriendly, needleless system of drug administration for pre-anaesthetic medication in paediatric patients. SETTINGS AND DESIGN: Tertiary hospital, a prospective, randomized, controlled, clinical study. METHODS AND MATERIAL: 60 ASA physical status I children of 2-5 years age group, weighing 10-18 kg scheduled for routine surgeries participated in the study. Children were randomly assigned to Group M: Received intranasal midazolam spray in doses of 0.2 mg/kg and Group N: Received normal saline drops (1-2 drops/nostril). Patients were observed in preoperative room for 20 min. Acceptance of drug, response to drug administration, sedation scale, separation score, acceptance to mask, recovery score and side effects of drug were noted. STATISTICAL ANALYSIS: Student 't' test, standard error of difference between two means and Chi-square test. p value<0.05 was considered as statistically significant. RESULTS AND CONCLUSION: 35% children in group M and 42.10% children in group N cried after drug administration who were not crying before drug administration (p>0.05). 20 min after premedication 76.66% in group M and 10.00% group N, children showed satisfactory sedation (p<0.05). 73.33% in group M while 26.66% in group N, children showed acceptable parental separation and 86.66% in group M while 23.33% group N, children showed satisfactory acceptance to mask (p<0.05). Transient nasal irritation in the form of rubbing of nose, watering, sneezing and lacrimation was observed in 40% children of group M. Intranasal midazolam by atomized spray is safe and effective premedicant in paediatric patients. It produces effective sedation and anxiolysis in children. Transient nasal irritation is an undesirable side effect observed with intranasal route.
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