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Injectable midazolam as oral premedicant in pediatric neurosurgery
L D Mishra1, G K Sinha, P Bhaskar Rao
1Department of Anesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi-221 005, India. ld_mishra@sify.com
Insights
Oral midazolam is an acceptable, effective, and safe premedicant for pediatric neurosurgery. The optimal dose of 0.75 mg/kg improves separation anxiety and reduces complications without delaying recovery.
Area of Science:
- Anesthesiology
- Pediatric Surgery
- Pharmacology
Background:
- Premedication in pediatric patients undergoing neurosurgery is crucial for managing anxiety and ensuring procedural safety.
- Injectable midazolam is commonly used for sedation, but its oral administration as a premedicant requires evaluation for efficacy and safety in this specific population.
- Assessing patient acceptability and potential side effects of oral midazolam is essential for clinical practice.
Purpose of the Study:
- To evaluate the acceptability, efficacy, and safety of injectable midazolam administered orally as a premedicant in children undergoing elective neurosurgical operations.
- To determine the optimal dosage of oral midazolam for pediatric neurosurgical patients.
- To compare the effects of different doses of oral midazolam against a placebo.
Main Methods:
- A randomized, double-blind, placebo-controlled study involving 100 pediatric patients (6 months to 6 years) undergoing elective neurosurgery.
- Patients were assigned to receive placebo or oral midazolam at doses of 0.50, 0.75, or 1.0 mg/kg, 45 minutes prior to separation from parents.
- Data collected included patient acceptability, reaction to separation, sedation scores, vital signs, anesthesia duration, recovery conditions, and side effects.
Main Results:
- Oral midazolam was found to be acceptable, with minimal vomiting or rejection after ingestion.
- Midazolam premedication improved the reaction to parental separation and reduced anxiety in the operating room compared to placebo.
- The 0.75 mg/kg dose demonstrated optimal efficacy and safety, with fewer complications and no delayed recovery, unlike the 1.0 mg/kg dose.
Conclusions:
- Injectable midazolam is an acceptable, effective, and safe oral premedicant for pediatric neurosurgical patients at a dose of 0.75 mg/kg.
- Lower doses (0.50 mg/kg) were less effective, while higher doses (1.0 mg/kg) did not offer additional benefits and potentially delayed recovery.
- The 0.75 mg/kg oral midazolam dose provides a favorable balance of efficacy, safety, and acceptable recovery characteristics in this pediatric population.
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.
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