Comparative study of oral midazolam syrup and intranasal midazolam spray for sedative premedication in pediatric surgeries

Abstract

Introduction: Midazolam is a water-soluble benzodiazepine which is frequently administered by intravenous and oral routes. Its nasal spray has become recently available. Materials and Methods: In this study, after obtaining clearance from the ethical committe, 66 patients between the age group of 4 and 10 years comparable in demographic variables were randomly allocated into two groups of 33 each. Group “O” received oral midazolam (0.5 mg/kg) 20 min before induction. Group “N” received intranasal midazolam (0.2 mg/kg) 20 min before induction. The heart rate and blood pressure (systolic, diastolic, and mean) and oxygen saturation (SPO 2 ) were recorded. Statistical Analysis Used: The statistical analysis was done using SPSS (Statistical Package for the Social Sciences) version 15.0 software. The values were represented in number (%) and mean±sd. Results: Satisfactory sedation scores were better in nasal spray group than oral group. Satisfactory ease of induction scores, recovery times, and postanesthesia recovery scores were better in the nasal spray group than in the oral group. Conclusion: Nasal midazolam spray is acceptable and is a good alternative to oral midazolam as premedication in the pediatric population.

Evaluation of Intranasal Midazolam for Pediatric Sedation during the Suturing of Traumatic Lacerations: A Systematic Review

“…Regarding the oral and intraoral routes, in the analysed studies, there were no significant differences among the oral, intraoral (oral mucosa) and intranasal administration of midazolam in terms of the degree of anxiety reduction [8,20,21], the total length of hospital stay [8,20] and the occurrence of adverse effects. This was evidenced in other studies that considered these routes safe and effective for sedation in children [25]. However, several studies showed that the intranasal route presents a faster initiation of action and a better sedation outcome [21,25,26] and better recovery of the child [25,27].…”

“…This was evidenced in other studies that considered these routes safe and effective for sedation in children [25]. However, several studies showed that the intranasal route presents a faster initiation of action and a better sedation outcome [21,25,26] and better recovery of the child [25,27].…”

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

“…6 We did not consider placebo control because the superiority of 0.2mgkg −1 -0.5mgkg −1 midazolam by intranasal route to placebo has already been well established in previous studies. [6][7][8] The children were selected in the age group of 2-6 years, because they have limited scope for psychological counselling. We opined that parental administration of drug would lower the incidence of stranger anxiety during administration and non-compliance, hence was adopted in the methodology of our research.…”

“…22 There were no adverse events like hypotension, respiratory depression, nausea and vomiting and delayed recovery from giving midazolam in our study and numerous other studies which makes it the safest drug there is for anxiolysis preoperatively. [6][7][8][9][10][11][12][13] Malinovisky has suggested neurotoxicity in rabbit with intranasal midazolam and ketamine premedication, 26 however recent researches refute the same by affirming that the low pH of the solution is responsible for neurotoxicity only when given epidurally or intrathecally. 27 Morever, many previous studies have used intranasal midazolam without any evidence of nasal mucosa damage or neurotoxicity.…”

“…27 Morever, many previous studies have used intranasal midazolam without any evidence of nasal mucosa damage or neurotoxicity. [6][7][8][9][10][11]13,22 There are several benefits and limitations to go with our research. All precautions were taken for improving drug acceptance which made premedication results better than all previous studies.…”