2016 aedating id product

The child improved after an oral airway was established and oxygen was administered.She was transferred to the ED, monitored for 12 hours, and then discharged.Chloral hydrate is rapidly converted to an active metabolite (trichloroethanol) responsible for its sedative properties, which has a half-life at therapeutic doses of up to 66 hours in neonates, 28-40 hours in infants, 8-12 hours in children, and much longer following an overdose.Ventricular dysrhythmias and severe hypotension leading to some fatalities from chloral hydrate toxicity have been reported.

(Only healthcare professionals should administer sedatives to children prior to a procedure after they have arrived at the facility to ensure proper supervision, monitoring, and access to resuscitation equipment and other medications if needed.) The dentist had anticipated repeat visits and prescribed 60 m L of chloral hydrate (100 mg/m L).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.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.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.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.Since 2010, ISMP has not received additional reports of errors involving pediatric sedation with chloral hydrate, which we assumed was due in large part to the 2012 discontinuation of the only remaining commercially available chloral hydrate products (oral solution by Pharmaceutical Associates, oral capsules by Breckenridge) in the US, for business reasons.comparing the previously available commercial formulation of chloral hydrate to the compounded formulation used for pediatric sedation during echocardiographic examination showed that the compounded drug resulted in a shorter duration of sedation, more frequent need for the use of a secondary sedation agent (increasing the risk of an adverse event), and more frequent sedation failure.

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