Lactium Premedication to Prevent Emergence Agitation

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 3 and 12 years old?YesNo

What the trial wants to find out

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.

The group in the trial

• Oral lactiumOther group

  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.

  Treatment: Lactium