Although chloral hydrate sedation has been proposed as an alternative to evaluation under anesthesia for pediatric patients who are unable to cooperate with routine test procedures, a careful study of the drug's safety and effectiveness is lacking. This study reports the effectiveness and safety of high-dose chloral hydrate for ophthalmic examination in 302 patients between the ages of 1 month and 5 years. The patients had nothing to eat or drink for 4 hours prior to drug administration. The patients were monitored during sedation and until fully awake. Eighty-eight percent of the patients (266/302) were successfully sedated without a supplemental dose. There were no reports of any complications including emesis, respiratory distress or depression, behavioral problems, changes in vital signs, patient injury, or hospital admission. The high-dose chloral hydrate protocol described, results in safe and generally successful sedation of pediatric patients for ophthalmic examination.