Injectable Midazolam as Oral Premedicant in Pediatric Neurosurgery

Abstract

In a randomized, double blind, placebo controlled study; the acceptability, efficacy and safety of injectable midazolam as oral premedicant in children was evaluated. One hundred children (ASA 1,2) aged 6 months to 6 years, undergoing elective neurosurgical operations, like meningomyelocele, meningo-encephalocele, ventriculo peritoneal and other shunts and craniotomies for tumour decompression etc., were included in the study. The patients were randomly assigned to one of four groups (A, B, C, D) receiving respectively saline or 0.50, 0.75 and 1.0 mg/kg midazolam in honey, 45 min before separation from parents. All received identical general anesthesia (GA). Age, sex, weight, heart rate, blood pressure, respiratory rate, saturation (SaO2), reaction to parent's separation, sedation score and duration of anesthesia, recovery conditions and side effects were noted. We found no difference in age, sex, weight, patient acceptability vomiting after ingestion and duration of anesthesia between groups. Even though many children resisted the placement of premedicant in the mouth, only three children spat it out and none vomited after swallowing. The reaction to separation from parents was better after midazolam premedication. However, on reaching the operating room, 24% children (placebo-60%) were found anxious after 0.50 mg/kg, but 12% were deeply sedated after a dose of 1.0 mg/kg. Recovery was similar in groups A, B and C except that more (48%) patients were anxious in group A. Recovery, however was delayed in 16% patients of group D. Though, fewer complications were reported during recovery after midazolam than placebo premedication, they were minimal in the 0.75 mg/kg group. We concluded that giving injectable midazolam orally as premedication in pediatric age group scheduled for neurosurgical operations is acceptable, effective and safe in 0.75 mg/kg dose. While 0.50 mg/kg is less effective, 1.0 mg/kg does not offer any additional benefit over 0.75 mg/kg but does delay recovery and may compromise safety.

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

“…In a study bySheta and Al Sarheed [14] apple syrup was used as a carrier. Mishra et al [17] mixed IV midazolam with honey [5 times the drug volume], which was well accepted by most of their subjects, in our study we have mixed midazolam with either flavoured paracetamol for oral preparation or with ketamine for nasal preparation. Adding paracetamol to oral preparation in addition to alleviating the bitter taste of midazolam it has analgesic effect, also many researchers recommended the addition of midazolam to ketamine to make use of ketamine as potent analgesic in the intraoperative as well as the postoperative analgesia and consequently decreasing postoperative agitation and speed up postoperative discharge.…”

Effectiveness of premedication agents administered prior to nitrous oxide/oxygen

“…Needleman et al 24 reported the incidence of vomiting as 8% in their studies when they used chloral hydrate together with hydroxyzine and N 2 O. Mishra et al 25 reported side effects such as nausea, vomiting, recovery agitation, and breathing depression following oral midazolam premedication at doses of 0.5, 0.75, and 1 mg kg À1 . In their study with 3 and 6 mg kg À1 ketamine, Gutstein et al 26 reported a significant increase in saliva secretion.…”

Administration of midazolam as sedative premedication for paediatric patients

“…A study of 100 cases indicated that oral midazolam was the most effective at 0.75 mg/kg while a dose of 0.5 mg/kg was less effective. Increasing the dose to 1.0 mg/kg did not show any advantages if compared to 0.75 mg/kg (18).…”