A Phase 2/3 interventional study of Lactium and Midazolam in Lactium, Midazolam and Behavior, 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 2026-11-10.
Sponsored by Tanta University · Phase 2/3, Interventional, and Prevention
This prospective randomized double-blind placebo-controlled study will be conducted to compare the effects of preoperative oral lactium and midazolam on the incidence of postoperative negative behavioral changes in young children undergoing adenotonsillectomy.
Pre-anesthetic sedation may reduce postoperative negative behavioral changes. Midazolam, a benzodiazepine receptor agonist, has been used in attempts to improve child cooperation with anesthesia induction, though with reported variation in effectiveness for benefit at the different stages in the pre-, intra-, and postoperative periods. 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. It has been shown to interact with gamma-aminobutyric acid A receptors to provide anxiolytic and anti-stress effects. In this novel study, we hypothesize that the pre-emptive premedication by oral administration of lactium or midazolam can decrease the incidence of negative behavioral changes in children undergoing adenotonsillectomy.
1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.
This study's planned enrollment of 180 is above the median of 120 across 1,197 interventional studies indexed under Behavior.
Browse Behavior studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cases will receive preoperative lactium (5 mg/kg). Each lentra sachet (containing 150 mg Lactium) will be totally dissolved in 60 ml water and (2 ml/kg) will be given to cases, 2 hours before surgery with a maximum dose of 300 mg.
Drug: Lactium
Cases will receive preoperative 0.5 mg/kg oral midazolam (maximum 20 mg), 30 minutes before surgery.
Drug: Midazolam
Cases will receive volume matched flavored solutions at each corresponding time point.
Other: Flavored oral solution
cases will receive preoperative lactium, each lentra sachet (containing 150 mg Lactium) will be totally dissolved in 60 ml water and 5 mg/kg (2 ml/kg) will be given to cases, 2 hours before surgery with a maximum dose of 300 mg. Also, they will receive volume matched and flavored matched water 30 minutes before surgery. The cups and the syringes will be opaque.
cases will receive 2 ml/kg of water dissolved into it a sweet- vanilla flavored powder, 2 hours before surgery. Also, 0.5 mg/kg oral midazolam (maximum 20 mg) will be given 30 minutes before surgery.
Cases will receive volume matched and flavored matched oral solution at each corresponding time point.
Incidence of negative behavioral changes at 24-h following surgery.
It will be assessed by a validated Arabic version of the Post Hospitalization Behavior Questionnaire (PHBQ). This is a 27-item questionnaire that was used to evaluate the child's behavior. Significant negative behavioral changes will be defined as ≥ 7 negative changes on the PHBQ items in comparison with the pre-anesthesia baseline values.
Time frame: 24 hours after surgery.
Incidence of negative behavioral changes at 3, 7, 14, 30 days following surgery.
It will be assessed by a validated Arabic version of the Post Hospitalization Behavior Questionnaire (PHBQ). This is a 27-item questionnaire that was used to evaluate the child's behavior. Significant negative behavioral changes will be defined as ≥ 7 negative changes on the PHBQ items in comparison with the pre-anesthesia baseline values.
Time frame: Up to 1 month after surgery
Incidence of emergence delirium.
It will be evaluated using the Pediatric Anesthesia Emergence Delirium scale (PAED) scale. A score \>12 together with a Delirium-specific score ≥ 9 will be considered a diagnostic endpoint for the development of delirium.
Time frame: Up to 1 hour after surgery.
Parent separation anxiety.
It will be assessed at the time of taking the child to the operating theatre by the attending anesthesiologist using the Parent Separation Anxiety Scale (PSAS). (13) The PSAS 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 PSAS score of 1 or 2 was considered as 'acceptable' separation.
Time frame: Perioperative.
Mask acceptance.
The ease of mask acceptance will be graded using the Mask Acceptance Score (MAS) at the time of induction of general anesthesia with sevoflurane. (14) The MAS scale is a 4-point Likert scale: 1 = excellent (unafraid, accepts mask readily); 2 = good (slight fear of mask, easily reassured); 3 = fair (moderate fear of mask, not calmed with reassurance); and 4 = poor (terrified, combative and crying). A MAS of 1 or 2 was considered 'satisfactory' mask acceptance
Time frame: Perioperative.
Postoperative pain.
Postoperative pain will be assessed using the Face, Legs, Activity, Cry and Consolability (FLACC) scale at post-anesthesia care unit arrival and every 0.25 hour for 1 hour after surgery.
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.
The total dose of rescue propofol.
Parental contact will be initiated as the first line management od delirium. If the PAED score remains at least 13 with a Delirium-specific score at least 9 despite parental contact, 1 mg/kg IV propofol will be administered. This dose will be repeated after 15 min if the child still agitated.
Time frame: Up to 1 hour after surgery.
The total dose of rescue fentanyl.
A FLACC score of at least 4 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.
Anxiety scores.
anxiety scores before the administration of the study drugs and during parent separation and during anesthesia induction will be assessed by the modified Yale preoperative anxiety scale-short form (m-YPAS-SF).
Time frame: Perioperative.
Side effects.
Postoperative nausea and vomiting, bradycardia, hypotension, respiratory events 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 May 2027, 6 months 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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Studies of the drugs tested here: Alpha-casozepine · Midazolam