"Preanaesthetic sedation with intranasal midazolam atomizer versus oral midazolam in paediatric patients” – a randomized comparative study
Authors: "Preanaesthetic sedation with intranasal midazolam atomizer versus oral midazolam in paediatric patients” – a randomized comparative study
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Background: Separation from the parents and unfamiliar operation theatre environment adds severe anxiety and apprehension to children. Therefore, an effective preanaesthetic medication for use in children undergoing surgery is required. In spite of plethora of research activities, premedication in children remains a controversial subject as various premedication and delivery systems have developed using different routes of administration.
Aims and objectives: To compare the safety, efficacy, ease of administration, acceptability, degree of sedation, anxiolysis and parental separation of midazolam by oral and intranasal spray for preanaesthetic sedation.
Materials and Methods: Sixty six ASA-I and ASA-II paediatric patients of age group one to ten years, scheduled for elective surgical procedures were divided into Nasal(N) group and Oral(O) who were randomised to receive either intranasal midazolam atomizer spray (0.4mg/kg) or oral midazolam syrup (0.5mg/kg). The demographic details, vital parameters, sedation score, anxiolytic score, separation score and drug acceptability were noted before administering the drug and at 10,20,30 minutes interval till parenteral separation was done.
Results: There was statistically significant increase in mean pulse rate at 10 minutes interval in group-N (P< 0.05). Though statistically significant increase in systolic blood pressure(SBP) was noted at all 3 intervals(P<0.05)in group O, statistically significant increase in diastolic blood pressure(DBP) was noted in group O only at 10 minutes of interval (P-value<0.05). Drug acceptability was good in group-O which was statistically significant(P- value <0.001). Sedation and anxiolysis were good in group-N compared to group-O but statistically significant scores were noted at 20 minutes interval (P<0.001, P<0.01 respectively). Parental separation in group-N was better compared to group-O which was not statistically significant.
Conclusion: Both the oral and nasal routes were equally safe. The transnasal route achieved faster sedation, anxiolytic and separation scores, virtually complete absorption as compared to oral syrup. Hence it may be preferred as a good alternative to oral midazolam. The oral route was better accepted by children.