Comparison between Oral Midazolam and Intranasal Midazolam for Sedative Premedication in Paediatric Patients: A Randomised Clinical Study

Introduction: Preoperative anxiety in paediatric patients can complicate anaesthetic induction and recovery. Midazolam is a commonly used sedative, administered either orally or intranasally. Aim: This study aimed to compare oral midazolam solution and intranasal midazolam spray for sedative premedication in paediatric patients. Materials and Methods: The present randomised clinical study was conducted on 100 children undergoing elective surgeries. Participants were divided into two groups: Group O (n=50) received oral midazolam (0.5 mg/kg), and Group I (n=50) received intranasal midazolam spray (0.2 mg/kg). Sedation levels were measured at 5, 10, 15, and 20 minutes using a Five-Point Sedation Score. Additional parameters included drug acceptance, ease of parental separation, mask acceptance, venepuncture response, and postoperative recovery using the Modified Aldrete Score. Data was analysed with Statistical Package for Social Sciences (SPSS) v21 with quantitative variables by mean, median, standard deviation, and range .Qualitative variables by frequency and percentage; comparisons between groups were performed using twotailed Student’s t-tests for continuous data and Chi-square tests for categorical data, with a significance threshold of p<0.05. Results: Baseline demographics were similar between groups (p>0.05). group I had a mean age of 2.9±2.54 years, and group O had 1.28±1.1 years. Gender distribution was nearly identical. group I showed significantly higher drug acceptance (50% good vs. 10% in group O; p<0.001), faster sedation onset, and superior sedation scores at 5, 10, and 15 minutes (p<0.001). Parental separation was smoother in group I (72% excellent vs. 40% in group O; p=0.005), as was mask acceptance (52% excellent vs. 40%; p=0.016). group I also demonstrated more favourable venepuncture responses (88% satisfactory vs. 68%; p=0.016). Postoperative recovery was faster and better in group I at all assessed intervals (p<0.05). Vital signs remained stable across both groups, with minimal adverse effects; only 6% in group I experienced mild nasal irritation. Conclusion: Intranasal midazolam spray is superior to oral midazolam for paediatric preoperative sedation, providing quicker and deeper sedation, better cooperation during procedures, smoother recovery, and higher overall acceptance, with minimal side-effects. Larger studies with extended followup are recommended to further evaluate long-term safety and behavioural outcomes.