From the Guidelines
The recommended oral dose of midazolam for pediatric sedation is 0.25–0.50 mg/kg, with a maximum dose of 20 mg, although children under 6 years old may require up to 1 mg/kg. This dosage is based on the study published in Pediatrics in 2008 1. When administering midazolam orally for pediatric sedation, it is essential to consider the child's age, weight, and the procedure's nature.
- Key considerations include:
- Dosing: 0.25–0.50 mg/kg, maximum 20 mg, with higher doses up to 1 mg/kg for children under 6 years old
- Administration timing: approximately 20-30 minutes before the procedure
- Palatability: mixing with a sweet liquid can improve compliance
- Monitoring: for respiratory depression, especially with other sedatives or underlying respiratory conditions
- Reversal agent: flumazenil should be available in case of overdose or adverse reactions. The medication works by enhancing the effect of gamma-aminobutyric acid (GABA), producing anxiolysis, sedation, and anterograde amnesia, as noted in the context of its pharmacological action 1.
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. For more anxious patients, doses up to 0. 5 mg/kg have been used.
The FDA drug label does not answer the question about the oral dosage of midazolam for pediatric sedation, as it only provides information on intramuscular and intravenous dosing. 2
From the Research
Oral Midazolam Dosage for Pediatric Sedation
The recommended oral dose of midazolam for pediatric sedation varies depending on the study and the specific context of sedation.
- A study published in 1994 3 used oral midazolam at a dose of 0.5 mg/kg for pediatric dental sedation.
- A study published in 1998 4 compared the safety and efficacy of two doses of oral midazolam (0.2 mg/kg and 0.5 mg/kg) for conscious sedation of children during minor procedures, and found that the higher dose (0.5 mg/kg) was more effective.
- A systematic review published in 2019 5 analyzed the efficacy of oral midazolam for minimal and moderate sedation in pediatric patients, and found that the range of oral midazolam doses providing effective sedation was between 0.25 mg/kg and 1.5 mg/kg.
- Another study published in 2023 6 reported that about 20% of responders selected a dosage range of 0.7 to 1 mg/kg for therapeutic oral midazolam dose, with 43% opting for a maximum dose of 20 mg irrespective of the child's weight.
Key Findings
- The efficacy of midazolam for pediatric minimal/moderate sedation from a dose of 0.25 mg/kg and above was demonstrated 5.
- The probability of occurrence of adverse events and over-sedation increases with increasing doses 5.
- Oral midazolam at a dose of 0.5 mg/kg was found to be safe and effective in sedating most children for minor procedures 4.
- The onset of action of oral midazolam was reported to be 15 minutes, with amnesia reported in 66% of children 4.