From the Guidelines
Yes, infants under 1 year of age can receive rectal Diastat (diazepam) 1.
Dosage Information
The exact dosage for infants under 1 year of age is not specified in the provided evidence, but for children and adolescents, the dosage is 0.03–0.06 mg/kg for endotracheal (ET) administration and 0.5 mg/kg up to 20 mg for rectal administration 1.
Clinical Considerations
It is essential to note that rectal diazepam may be useful when IV access is unavailable, but absorption may be erratic 1. Additionally, diazepam should be followed immediately by a long-acting anticonvulsant, such as phenytoin/fosphenytoin, because it is rapidly redistributed and seizures often recur within 15–20 min 1.
Guidelines and Recommendations
The British Paediatric Association recommends giving parents instructions about the management of fever and the use of rectal diazepam 1. The American Academy of Pediatrics discusses the benefits and risks of intermittent anticonvulsant therapy, including rectal diazepam, for the long-term management of children with simple febrile seizures 1.
From the FDA Drug Label
Safety and effectiveness in pediatric patients below the age of 6 months have not been established.
The FDA drug label does not provide information to support the use of rectal Diastat (diazepam) in infants under 1 year of age. Diazepam is not established as safe and effective in pediatric patients under 6 months of age. Therefore, it is not recommended to administer rectal Diastat to infants under 1 year of age due to the lack of sufficient clinical experience and established safety and efficacy in this age group 2.
From the Research
Efficacy of Rectal Diastat in Infants
- The provided studies do not directly address the use of rectal Diastat (diazepam) in infants under 1 year of age 3, 4, 5, 6, 7.
- However, one study mentions the treatment of febrile convulsions in children aged 6 months to 5 years with rectal administration of diazepam in solution, which was effective in 80% of cases 6.
- Another study discusses the use of rectal diazepam gel for treatment of acute repetitive seizures in children aged 2-17 years, which demonstrated a significant reduction in median seizure frequency compared to the placebo group 7.
Safety Considerations
- The studies report few side effects, including somnolence, respiratory difficulties, dizziness, and skin reactions 5, 6, 7.
- No significant respiratory depression was observed in the studies 3, 6, 7.
- The safety and efficacy of rectal Diastat in infants under 1 year of age cannot be determined from the provided evidence.
Age-Related Considerations
- The age range of the subjects in the studies varies from 6 months to 18 years, but none of the studies specifically focus on infants under 1 year of age 3, 4, 5, 6, 7.
- The dosage and administration of rectal diazepam may need to be adjusted for infants under 1 year of age, but this is not addressed in the provided studies.