Clinical Research Directory

Lactium solution will be prepared by dissolving each one lentra sachet (150 mg lactium per sachet) in 50 ml of water so that each ml will contain 3 mg of lactium. Oral lactium will be initiated at a dose of 4 mg/kg in the first patient. Dose in subsequent cases will be determined by response to lactium in previous patient using absence or presence of emergence agitation as our primary outcome. A dosing interval of (1 mg/kg) will be used. If the child has no agitation, the subsequent one will receive the same dose with a probability of 0.89 or a reduced dose by 1 mg/kg with a probability of 1/9 (0.11). If the child develops agitation, the subsequent dose will be increased by 1 mg/kg with 100% certainty. If the child responds to the dose of 4 mg/kg, the dose for the next child will remain the same, since this is our minimum dose.