Premedication With Midazolam Nasal Spray: An Alternative to Oral Midazolam in Children

BACKGROUND: Midazolam is a water soluble benzodiazepine which is frequently administered by intravenous and oral routes in our institution. Its nasal spray has become recently available. OBJECTIVES: To compare the efficacy of midazolam administered orally and by intranasal spray, with the specific objective of assessing their efficacy in terms of acceptability to the patients, whether they achieve a satisfactory sedation score, and the overall ease of inducing general anesthesia. PATIENTS AND METHODS: Sixty healthy children of ASA grade I or II, aged 2–6 years who were undergoing elective surgery of approximately 30 minutes duration, were assigned to receive midazolam premedication in a randomized controlled trial. They were divided into 2 groups of 30 patients each. Group I: 30 patients received midazolam orally (parenteral solution mixed in honey). Group II: 30 patients received a commercially available midazolam nasal spray. RESULTS: The study shows that children better accepted the drug when administered orally than when administered intranasally, although satisfactory sedation scores at 10 and 20 minutes were better in the nasal spray group than in the oral group [i.e., 6 (20%) vs. 0 (0%) at 10 min and 16 (53.3%) vs. 13 (43.3%), respectively]. Satisfactory ease of induction scores [24 (80%) vs. 13 (43.3%)], recovery times [11.63 ± 4.19 minutes vs. 25.20 ± 9.36 minutes], and post-anesthesia recovery scores were better in the nasal spray group (group II) than in the oral group (group I). CONCLUSIONS: On the basis of our study, we conclude that nasal midazolam spray is acceptable and is a good alternative to oral midazolam as premedication in the pediatric population.