A study to compare clinical efficacy and safety of two different doses of intranasal midazolam as premedication for paediatric surgery

Amandeep Singh, Chashamjot Bawa, Aditya Sharma, Jyoti Raina, Mehak Dureja

Abstract


Introduction: Intranasal midazolam is convenient form of premedication in children with favourable pharmacokinetics and no side-effects. This study was carried out to compare two different doses of intranasal midazolam as premedication in paediatric surgery.
Materials and Methods: After taking institutional ethics committee approval and informed consent, sixty patients aged 2 to 6 years undergoing elective surgeries were randomised into two groups (n=30 each) to receive 0.2mgkg􀀀1 (Group A) and 0.3 mgkg􀀀1 (Group B) intranasal midazolam in the pre-operative area.
Vital parameters were taken at 5 minute intervals till sevoflurane induction. 5-point sedation score was recorded at 5 minutes, 10 minutes, after parental separation at 15 minutes and modified to show compliance with fack mask induction at 20 minutes. Side effects during the study were also compiled.
Results: Demographic data including age, gender and weight distribution were comparable in both groups.
All haemodynamic parameters remained similar in both the groups (P>0.05). Significantly higher number of patients (24 versus 12 in group B and A respectively) had onset of sedation (score 3, 4) at 5 minutes while sedation levels were comparable at 10 minutes. Lesser number became agitated on parental separation and face mask induction (P-values 0.044, 0.126 respectively) in group B, former being significant. No side effects were observed during the study.
Conclusion: Intranasal midazolam in both the dosages provides satisfactory conditions for parental separation and face mask induction in children. However, larger dose can be used for earlier onset, with higher probability of adequate sedation levels, no side effects deterring its use.


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