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

Abstract

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.

Preoperative Oral Sedation with Midazolam and Paracetamol vs Sedation Nasally with Midazolam and Ketamine for Children Scheduled for Dental Treatment

“…The oral midazolam and paracetamol was much more acceptable than the nasal midazolam and ketamine route by the child and achieved a higher parent satisfaction score, this is similar to the result of Verma et al [16] who stated that the children better accepted the drug when administered orally than when administered intranasally. Despite this, the intranasal route has a satisfactory sedation level in a shorter time.…”

“…and the patients discharged earlier from the hospital [at 15 min 77.8% of the patients in group o were discharged vs. 46.7% in group N]. This does not meet the results in the study done by Verma et al [16] On comparing the effect of oral and nasal midazolam, they stated that the recovery times [11.63 ± 4.19 minutes in nasal group vs. 25.20 ± 9.36 minutes in the oral group], and post-anesthesia recovery scores were better in the nasal spray group and this was same in the clinical study done by Sheta and AlSarheed [14] where they used oral midazolam as a premedication for dental care, The delay in the nasal route in our study could be attributed to the addition of ketamine in the nasal group…”

“…The premedication must be acceptable, and atraumatic route of administration should be available [16] [17] [18].…”

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“…Solubility and solubilization power are reported in Table 5. 2,21 . Since midazolam has short half-life and delay of action, it is commonly employed in children pre-anesthesia 4 .…”

“…It is also administered in status epilepticus in children 1,2 . Midazolam is a weak acid (pKa 6.2) in pH>4 and exists in un-ionized form 3 , with hydrophobic properties in neutral and physiological pH 4 therefore, it is commercially formulated in acidic pH (approximately 3) for better solubility, which cause pain and irritation in administration site 2,5 .…”