Dose and administration

1. 25-50 mg/kg/day divided into 4-6 doses PO. Administer after feeding to reduce gastric irritation.

Indication

1. Restlessness requiring sedation.

Contraindications and Precautions

1. Known hypersensitivity to chloral hydrate.
2. Pain.
3. Caution in infants with respiratory distress.
4. Caution in preterm infant, especially extreme immaturity.
5. Caution in infants with hepatic or renal impairment.

Clinical Pharmacology

Trichloracetaldehyde hydrate is a central nervous system depressant (sedative and hypnotic). The action of the drug is confined to the cerebral hemispheres. The drug has virtually no effect upon REM sleep. Has no analgesic properties.

Well absorbed from the gastrointestinal tract and distributes widely in the body (Vd 1-2 L/kg). Hepatic metabolism by alcohol dehydrogenase to trichloroethanol, an active metabolite. Moderate binding (35-40%) of trichloroethanol to human plasma protein. Elimination via the kidney as a glucuronide. Clearance is very variable in neonates. Elimination half life 8-64 hours (mean 37 hours).

Relatively safe sedative and hypnotic drug. Lethal therapeutic-toxic ratio is lower than for diazepam. Onset of action 30-60 minutes. Duration of action 4-8 hours.

Possible Adverse Reactions

1. Gastric irritation
2. Respiratory depression
3. Vasodilation, hypotension, cardiac arrhythmias, myocardial depression.
4. CNS depression
5. Paradoxical excitement (especially if given to neonates with pain).

Special Considerations

1. Chloral hydrate should be used cautiously in neonates. Tolerance and physical dependence possible with prolonged use. Review continuing use at frequent intervals.
2. Accumulation of major metabolites may occur with long-term administration, especially in very immature neonates, or those with hepatic and/or renal dysfunction.