Plasma-diazepam in infants after rectal administration in solution and by suppository

Area of Science:

• Pediatrics
• Clinical Pharmacology
• Neurology

Background:

• Febrile convulsions are common in infants and young children.
• Prompt treatment is crucial to manage seizures effectively.
• Rectal diazepam is a potential option for acute management.

Purpose of the Study:

• To compare the pharmacokinetic profiles of rectal diazepam solution versus suppository in infants.
• To determine the onset of anticonvulsant plasma levels for each formulation.
• To evaluate the potential utility of rectal diazepam for home treatment of febrile convulsions.

Main Methods:

• A randomized study involving 20 infants aged 1-2 years with a history of febrile convulsions.
• Administration of a single rectal dose of diazepam, either as a solution (0.7 mg/kg) or suppository (5 mg).
• Repeated plasma-diazepam level measurements during the first hour post-administration using gas chromatography.

Main Results:

• Diazepam solution administered rectally achieved anticonvulsant plasma levels within 4 ± 1 minutes.
• Similar plasma levels were achieved with diazepam suppositories only after 20-30 minutes.
• Diazepam solution demonstrated significantly faster absorption compared to suppositories.

Conclusions:

• Rectal diazepam in solution offers rapid absorption and may be effective for acute febrile convulsions.
• Diazepam suppositories showed delayed absorption, limiting their utility in acute seizure management.
• Rectal diazepam solution shows promise for home use in recurrent febrile convulsions, pending further safety and efficacy data.