LactiumPhase 3NCT07894484
Lactium Premedication to Prevent Emergence Agitation
A Phase 3 study testing Lactium in people with Lactium and Premedication, run by Tanta University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Lactium, Premedication, Emergence Agitation
- What is being tested?
- Lactium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2026to 24 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 to 12 years
- American Society of Anesthesiologist (ASA) Status I or II
- Planned for an adenotonsillectomy procedure under sevoflurane general anesthesia.
Who cannot join
- Parents declined to participate in the trial
- Behavioral changes, neurological or psychiatric problems
- Anticonvulsant or sedative drugs
- Physical or developmental abnormalities
- cardiovascular, renal, or gastrointestinal diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Tanta University Hospitals
Tanta, Gharbia Governorate, 31527
Osama M Rehab, MD, 01095210806 ext. 002, osamarehab@med.tanta.edu.eg
About this study
Official title: Lactium Premedication to Prevent Emergence Agitation: A Dose-Finding Study in Children Undergoing Adenotonsillectomy
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.
Read the detailed description
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.
- Being tested
- Lactium
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactiumDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral lactium | Other | 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. Receives: Drug: Lactium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of emergence agitation. The dose of lactium that is required to prevent the occurrence of emergence agitation in 90% of children (ED90) will be the primary aim of this study.
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. The estimated dose (ED90) of lactium and its 95% confidence interval will be estimated using the Dixon and Mood method and isotonic regression.
Measured: Up to 1 hour after surgery
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Perioperative
Side effects
Postoperative nausea and vomiting, hypotension, bradycardia will be recorded
Measured: Up to 1 hour after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start10 Nov 2026 (estimated)
- Primary completion10 Dec 2026 (estimated)
- Study completion24 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactiumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Rehab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894484
- Sponsor's protocol ID
- 36265PR251/10/26
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactium Premedication to Prevent Emergence Agitation: A Dose-Finding Study in Children Undergoing Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT07894484
- Acronym / sponsor ID
- 36265PR251/10/26
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 24 Dec 2026 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral lactium | Other | Drug: LactiumOral 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. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 3 to 12 years
- American Society of Anesthesiologist (ASA) Status I or II
- Planned for an adenotonsillectomy procedure under sevoflurane general anesthesia.
Key exclusion criteria (5 listed)
- Parents declined to participate in the trial
- Behavioral changes, neurological or psychiatric problems
- Anticonvulsant or sedative drugs
- Physical or developmental abnormalities
- cardiovascular, renal, or gastrointestinal diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LactiumLactium 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. | Drug | Oral lactium |
Primary outcome
Incidence of emergence agitation. The dose of lactium that is required to prevent the occurrence of emergence agitation in 90% of children (ED90) will be the primary aim of this study.
Time frame: Up to 1 hour after surgery
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. The estimated dose (ED90) of lactium and its 95% confidence interval will be estimated using the Dixon and Mood method and isotonic regression.
7 secondary outcomes
Postoperative pain
Time frame: Up to 1 hour after surgery
Parental separation anxiety
Time frame: Perioperative
The total dose of rescue fentanyl
Time frame: Up to 1 hour after surgery
Extubation time
Time frame: End of surgery
Negative behavior changes
Time frame: Up to 1 week after surgery.
Modified Yale preoperative anxiety scale-short form.
Time frame: Perioperative
Side effects
Time frame: Up to 1 hour after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactium in people with Lactium and Premedication, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osama M Rehab, MD (01095210806 ext. 002, osamarehab@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of emergence agitation. The dose of lactium that is required to prevent the occurrence of emergence agitation in 90% of children (ED90) will be the primary aim of this study. (time frame: Up to 1 hour after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.