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.

Background:An ideal pre-medicant should allay fear and anxiety without producing its effect on vital functions of the body and body chemistry, with minimal depression of the respiratory and circulatory systems. The ideal pre-medicant with all good qualities and no side effects at all is yet to be found. The search for a drug which will be an appropriate pre-anesthetic medication is still going.Methods: Four drugs of BZD group namely diazepam, nitrazepam, lorazepam, and oxazepam were chosen as oral pre-anesthetic medication. Total number of cases were 100, of which 25 patients belonging to each group of drug respectively. Standard doses of oxazepam (30 mg), nitrazepam (5 mg), diazepam (10 mg) and lorazepam (2 mg) by oral route were administered. All study participants were examined night before operation to observe the following clinical parameters like level of apprehension, excitement, blood pressure, heart rate, respiration (rate, rhythm and minute volume).Results:Diazepam and nitrazepam produced fair degree of sedation whereas oxazepam appears to be lagging behind. So far as anxiolysis is concerned, all the drugs appear to be good anxiolytics. Nausea, vomiting and dizziness are some of the problems which may occasionally be faced by this group of drug. On reassessment of patients 60 minutes after premedication, it was revealed that the efficacy so as anxiolysis and sedative effect is concerned was in the following order, lorazepam headed the list; diazepam and nitrazepam followed closely and oxazepam was at the bottom. Toxicity in all the four drugs were minimal. The degree of sleepiness varied from drug to drug. Ninety minute after premedication patients were found to be in a better state of sedation than at 60 minute’s level in all the four groups. The degree of sedation and anxiolysis was in the same order as that of 60 minutes level.Conclusions:The overall impression was that four members of the benzodiazepines, serve as as a good premedication in the absence of pain. The sedation and anxioysis produced by them are of fair degree even when given orally. Side effects produced were minimal except in the lorazepam group when they are used as night time sedative. Given orally only lorazepam is capable of producing anterograde amnesia.