The third event involved a 15-month-old child with a history of severe neurodevelopmental deficits who was given 1,200 mg of chloral hydrate (100 mg/kg) at an outpatient ophthalmology clinic prior to evaluation.Within 25 minutes of receiving the drug, the child vomited, became obtunded, and developed stridor, periods of apnea, and cyanosis.We were thinking about removing chloral hydrate from our lists of high-alert medications but have not done so given the unknown frequency of prescribing and compounding the drug.
There are no FDA-approved drug products that contain chloral hydrate.
As mentioned above, the firms commercially manufacturing and distributing drug products containing chloral hydrate without FDA-approval voluntarily removed their products from the market in 2012.
In a third fatality, a dentist ordered a weight-based dose of 6,000 mg for a 13-year-old child that led to respiratory arrest.
In three more cases, the drug was administered to the child by a parent at home prior to a procedure.
The child became somnolent within 10 minutes and unresponsive once in the dental office.
The mother alerted the office staff, who called emergency medical services.
Sedation of pediatric patients for even painless diagnostic procedures is common because its use has been linked to higher quality studies and reduced diagnostic errors.
Between 19, ISMP published dozens of errors about chloral hydrate used for sedation involving mostly dosing errors, oversedation, and administration of the oral liquid by the IV route.
Chloral hydrate can result in prolonged sedation or resedation with effects persisting beyond 24 hours in children of all ages, including those who have demonstrated resolution of sedation prior to discharge.
This appears to have played a role in the fatality of the 4-year-old girl described previously.
Resuscitation efforts prehospital and in the ED were extensive, with an initial return of spontaneous circulation. The next event involved a 3-year-old boy for whom a dentist had prescribed 500 mg (50 mg/kg) of chloral hydrate to be administered at home prior to arrival in the office for a dental procedure.