A Phase 3 interventional study of Lactium in Lactium, Premedication and Emergence Agitation, sponsored by Tanta University. Not yet recruiting at 1 site in Egypt. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Tanta University · Phase 3, Interventional, and Prevention
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.
Lactium is a synthetic derivative of alpha-s1 casein hydrolysate (ACH) containing the alpha-casozepine peptide, which is one of the main components of milk protein. ACH derived from bovine milk, contains benzodiazepine-like α-casozepine, which has been shown to interact with gamma-aminobutyric acid (GABA) A receptors to provide anxiolytic and anti-stress effects. These effects are attributed to a specific decapeptide in ACH, which mirrors the flexible A-B-C ring structure of classic benzodiazepines. In this novel study, the investigators will determine the effective lactium dose, when given orally before surgery, to prevent emergence agitation in 90% of children (ED90) undergoing adenotonsillectomy.
789 studies on the registry are indexed under Emergence Delirium; 250 are open to participants now.
This study's planned enrollment of 40 is below the median of 120 across 491 interventional studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Tanta University is the lead sponsor of 991 studies on the registry; 316 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
Drug: Lactium
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.
Incidence of emergence agitation
Pediatric Anesthesia Emergence Delirium scale will be used and a score \> 10 together with a Delirium-specific score ≥ 6 (in absence of pain) will be considered a diagnostic endpoint for the development of agitation. it will be assessed on arrival to the post-anesthesia care unit and every 15 min thereafter for 1 hour
Time frame: Up to 1 hour after surgery
Postoperative pain
the Face, Legs, Activity, Cry and Consolability (FLACC) scale or the Faces Pain Scale-Revised or the Numerical Rating Scale will be used to assess the pain degree as applicable for age at post-anesthesia care unit. A pain score more than 3 will be treated with 0.5mcg/kg of IV fentanyl
Time frame: Up to 1 hour after surgery
Parental separation anxiety
It will be assessed at the time of taking the child to the operating theater by the attending anesthesiologist using the Parent Separation Anxiety Scale. It ranges from one to four where one refers to easy separation; two equals whimpers; three denotes that the child cries and cannot be easily reassured but not clinging to parents; and 4 signifies crying and clinging to parents. A score of 1 or 2 was considered as 'acceptable' separation
Time frame: Perioperative
The total dose of rescue fentanyl
A pain score more than 3 will be treated with 0.5mcg/kg of IV fentanyl. This dose will be repeated after 15 min if the child still in pain. The total dose of rescue fentanyl will be recorded
Time frame: Up to 1 hour after surgery
Extubation time
At the end of surgery, the trachea will be extubated with the patient in the lateral position after confirmation that the gag reflex returned
Time frame: End of surgery
Negative behavior changes
Post Hospitalization Behavior Questionnaire will be used to evaluate the child's baseline behavior before anesthesia and any negative behavioral changes at 24 hours, 72 hours, and one week postoperatively. Significant negative behavioral changes will be defined as ≥ 7 negative changes on the Post Hospitalization Behavior Questionnaire items in comparison with the pre-anesthesia baseline values.
Time frame: Up to 1 week after surgery.
Modified Yale preoperative anxiety scale-short form.
Anxiety scores before the administration of the study drug, during parent separation, and during anesthesia induction will be assessed by the modified Yale preoperative anxiety scale-short form.
Time frame: Perioperative
Side effects
Postoperative nausea and vomiting, hypotension, bradycardia will be recorded
Time frame: Up to 1 hour after surgery.
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author.
Supporting information: Study protocol, Statistical analysis plan
Time frame: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Access criteria: The data will be available upon a reasonable request from the corresponding author.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2026, 1 month later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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