What is the recommended dose of buccal midazolam (Benzodiazepine) for pediatric patients?

From the Guidelines

The recommended dose of buccal midazolam for pediatric patients is not explicitly stated in the provided evidence, but based on general medical knowledge, the typical dose ranges from 2.5 mg to 10 mg, depending on the age and weight of the child. For pediatric patients, the dose of buccal midazolam is crucial for effective management of seizures or anxiety while minimizing the risk of adverse effects.

• The dose for children typically ranges as follows:
  • 2.5 mg for children 3 months to 1 year
  • 5 mg for children 1-5 years
  • 7.5 mg for children 5-10 years
  • 10 mg for children 10-18 years However, it's essential to note that the provided evidence 1 discusses the use of midazolam in a different context (managing COVID-19 symptoms) and does not specifically address pediatric dosing for buccal administration.
• Administration of buccal midazolam involves placing the solution between the gum and cheek, allowing for rapid absorption through the oral mucosa.
• This method is particularly useful in community settings where intravenous access may not be available, such as in acute seizure management.
• Monitoring for respiratory depression is critical after administration, especially in younger children or those with pre-existing respiratory conditions. Given the lack of specific guidance from the provided evidence, the decision on the exact dose should be made on a case-by-case basis, considering factors such as the child's age, weight, medical history, and the presence of any conditions that may affect drug metabolism or increase the risk of side effects.

From the FDA Drug Label

The health care practitioner who uses this medication in pediatric patients should be aware of and follow accepted professional guidelines for pediatric sedation appropriate to their situation USUAL PEDIATRIC DOSE (NON-NEONATAL) For sedation/anxiolysis/amnesia prior to anesthesia or for procedures, intramuscular midazolam can be used to sedate pediatric patients to facilitate less traumatic insertion of an intravenous catheter for titration of additional medication Doses of 0.1 to 0.15 mg/kg are usually effective and do not prolong emergence from general anesthesia. Although not systematically studied, the total dose usually does not exceed 10 mg.

The recommended dose of buccal midazolam for pediatric patients is not explicitly stated in the provided drug label. The label provides dosing information for intramuscular and intravenous administration, but does not mention buccal administration. Therefore, no conclusion can be drawn about the recommended dose of buccal midazolam for pediatric patients based on this information 2.

From the Research

Buccal Midazolam Pediatric Dose

The recommended dose of buccal midazolam for pediatric patients varies according to age and weight.

• A study published in the Lancet in 2005 3 used a dose that varied from 2.5 to 10 mg according to age.
• Another study published in Brain & Development in 2003 4 used a dose of 0.3 mg/kg for children aged from 1 month to 15 years.
• A review of oromucosal midazolam published in Paediatric Drugs in 2012 5 stated that the drug is approved for the treatment of pediatric patients with acute, prolonged, convulsive seizures, with a rapid onset of action and short duration of effect.

Efficacy and Safety

• The study published in the Lancet in 2005 3 found that buccal midazolam was more effective than rectal diazepam for children presenting to hospital with acute seizures.
• The study published in Brain & Development in 2003 4 found that 84.2% of seizures stopped within 10 min of buccal midazolam being given, with no clinically important side effects seen in any patient.
• The review published in Paediatric Drugs in 2012 5 stated that oromucosal midazolam is at least as effective as rectal diazepam and as effective as intravenous diazepam in the treatment of children with prolonged acute convulsive seizures, and is generally well tolerated in this population.

Administration and Acceptability

• A study published in the European Journal of Paediatric Neurology in 2010 6 found that buccal midazolam was significantly more acceptable than rectal diazepam, with 94% of parents satisfied with their child's treatment and route of drug administration.
• The review published in Paediatric Drugs in 2012 5 stated that oromucosal midazolam has several advantages over rectal diazepam, including a more socially acceptable administration route and a likely more predictable absorption profile.