Lactium Premedication to Prevent Emergence Agitation

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• 3 és 12 év között vagy?IgenNem

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This biased coin sequential allocation, dose finding study will be conducted to determine the effective dose of oral lactium in 90% of children (ED90) for prevention of emergence agitation during recovery from adenotonsillectomy.

A vizsgálat csoportja

• Oral lactiumEgyéb csoport

  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. A maximum dose of 300 mg lactium is chosen for this trial. 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.

  Kezelés: Lactium