LactiumNCT07172594
Preemptive Oral Lactium to Prevent Emergence Agitation
A study testing Lactium in people with Lactium and Emergence Agitation, run by Tanta University at 1 site in Egypt.
Trial summary
This prospective randomized controlled study will be conducted to evaluate the effects of preoperative lactium on the incidence and severity of emergence agitation in children undergoing adenotonsillectomy using sevoflurane anesthesia. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Lactium, Emergence Agitation, Adenotonsillectomy
- What is being tested?
- Lactium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Sep 2025to 8 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both gender
- 4 to 7 years age
- American Society of Anesthesiologists (ASA) Physical Status I or II
- Scheduled for adenotonsillectomy surgery under sevoflurane anesthesia
Who cannot join
- Parents declined to participate in the trial
- Children with behavioral changes; neurological or psychiatric diseases
- Physical or developmental delay
- Sedative or anticonvulsant medication
- Pre-existing renal or cardiovascular disease, bone disease, or gastrointestinal disorders
- • History of lactose intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preemptive Oral Lactium Supplement to Prevent Emergence Agitation in Children Undergoing Adenotonsillectomy: A Randomized Placebo Controlled Study
This prospective randomized controlled study will be conducted to evaluate the effects of preoperative lactium on the incidence and severity of emergence agitation in children undergoing adenotonsillectomy using sevoflurane anesthesia.
Read the detailed description
Emergence agitation is a frequent postoperative complication in pediatric patients receiving inhalational anesthetics with a rapid recovery profile, e.g. sevoflurane. There is a wide variation in the reported incidence, with estimates ranging from 30% to 80%, depending on the definition, assessment tool and time frame of monitoring in the recovery period. 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 contains benzodiazepine-like α-casozepine, which has been shown to interact with gamma-aminobutyric acid receptors to provide anxiolytic and anti-stress effects. In this novel study, we hypothesize that the pre-emptive administration of Lactium may decrease emergence agitation incidence in children undergoing adenotonsillectomy. Given the fact that preoperative anxiety and parent separation are predictors for emergence agitation , the efficacy of Lactium in alleviating stress-related symptoms, that may be obtained before anesthetic induction may explain its prophylactic benefit against emergence agitation .
- Conditions
- Lactium, Emergence Agitation, Adenotonsillectomy
- Being tested
- Lactium, Placebo control
- 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
Lentra sachet (containing 150 mg Lactium) will be totally dissolved in 100 ml water and 50 ml will be given to cases, 2 hours before surgery.
Placebo controlOther
50 ml water added to it powdered vanilla flavor will be given to cases 2 hours before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Lactium group | Experimental | cases will receive preoperative lactium, Lentra sachet (containing 150 mg Lactium) will be totally dissolved in 100 ml water and 50 ml will be given to cases, 2 hours before surgery. Receives: Drug: Lactium |
| Control group | Placebo comparator | cases will receive 50 ml water added to it powdered vanilla flavor, 2 hours before surgery. Receives: Other: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of emergence agitation
Pediatric Anesthesia Emergence Delirium scale scores will be used and a score ≥ 10 will be considered to be a diagnostic endpoint for the development of agitation. It will be assessed on arrival to the post anesthesia care unit (PACU), and every 15 min thereafter for 1 hour
Measured: Up to 1 hour after surgery.
Secondary outcomes (6)
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 will be considered as 'acceptable' separation
Measured: Perioperative
Mask Acceptance Score
Ease of mask acceptance will be graded using the Mask Acceptance Score. It is a 4-point 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 score of 1 or 2 will be considered 'satisfactory' mask acceptance
Measured: Perioperative
Postoperative pain
the Face, Legs, Activity, Cry and Consolability (FLACC) scale will assess the pain degree at PACU arrival and every 0.25 hour for 1 hour after surgery. A FLACC score of at least 4 will be treated with 0.5mcg/kg of IV fentanyl.
Measured: Up to 1 hour after surgery.
Total dose of rescue fentanyl
Fentanyl will be given for agitation or pain
Measured: Up to 1 hour after surgery.
Pediatric Anesthesia Emergence Delirium scale scores
severity of agitation will be assessed by Pediatric Anesthesia Emergence Delirium scale.
Measured: Up to 1 hour after surgery.
Number of patients who will develop postoperative nausea and vomiting.
Any episodes of nausea and vomiting will be recorded.
Measured: Up to 2 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start22 Sep 2025
- Primary completion8 Jan 2026
- Study completion8 Jan 2026
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.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Emad Eissa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172594
- Sponsor's protocol ID
- 36264PR1306/7/25
- Status last verified
- Jan 2026
- First submitted
- 8 Sep 2025
- Last updated
- 13 Jan 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 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Oral Lactium Supplement to Prevent Emergence Agitation in Children Undergoing Adenotonsillectomy: A Randomized Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT07172594
- Acronym / sponsor ID
- 36264PR1306/7/25
- Conditions
- Lactium, Emergence Agitation, Adenotonsillectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 15 Sep 2025 (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 prospective randomized controlled study will be conducted to evaluate the effects of preoperative lactium on the incidence and severity of emergence agitation in children undergoing adenotonsillectomy using sevoflurane anesthesia.
Detailed description
Emergence agitation is a frequent postoperative complication in pediatric patients receiving inhalational anesthetics with a rapid recovery profile, e.g. sevoflurane. There is a wide variation in the reported incidence, with estimates ranging from 30% to 80%, depending on the definition, assessment tool and time frame of monitoring in the recovery period. 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 contains benzodiazepine-like α-casozepine, which has been shown to interact with gamma-aminobutyric acid receptors to provide anxiolytic and anti-stress effects. In this novel study, we hypothesize that the pre-emptive administration of Lactium may decrease emergence agitation incidence in children undergoing adenotonsillectomy. Given the fact that preoperative anxiety and parent separation are predictors for emergence agitation , the efficacy of Lactium in alleviating stress-related symptoms, that may be obtained before anesthetic induction may explain its prophylactic benefit against emergence agitation .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Lactium group | Experimental | Drug: Lactiumcases will receive preoperative lactium, Lentra sachet (containing 150 mg Lactium) will be totally dissolved in 100 ml water and 50 ml will be given to cases, 2 hours before surgery. |
| Control group | Placebo comparator | Other: Placebo controlcases will receive 50 ml water added to it powdered vanilla flavor, 2 hours before surgery. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Both gender
- 4 to 7 years age
- American Society of Anesthesiologists (ASA) Physical Status I or II
- Scheduled for adenotonsillectomy surgery under sevoflurane anesthesia
Key exclusion criteria (6 listed)
- Parents declined to participate in the trial
- Children with behavioral changes; neurological or psychiatric diseases
- Physical or developmental delay
- Sedative or anticonvulsant medication
- Pre-existing renal or cardiovascular disease, bone disease, or gastrointestinal disorders
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 |
|---|---|---|
| LactiumLentra sachet (containing 150 mg Lactium) will be totally dissolved in 100 ml water and 50 ml will be given to cases, 2 hours before surgery. | Drug | Lactium group |
| Placebo control50 ml water added to it powdered vanilla flavor will be given to cases 2 hours before surgery. | Other | Control group |
Primary outcome
Incidence of emergence agitation
Time frame: Up to 1 hour after surgery.
Pediatric Anesthesia Emergence Delirium scale scores will be used and a score ≥ 10 will be considered to be a diagnostic endpoint for the development of agitation. It will be assessed on arrival to the post anesthesia care unit (PACU), and every 15 min thereafter for 1 hour
6 secondary outcomes
Parental separation anxiety
Time frame: Perioperative
Mask Acceptance Score
Time frame: Perioperative
Postoperative pain
Time frame: Up to 1 hour after surgery.
Total dose of rescue fentanyl
Time frame: Up to 1 hour after surgery.
Pediatric Anesthesia Emergence Delirium scale scores
Time frame: Up to 1 hour after surgery.
Number of patients who will develop postoperative nausea and vomiting.
Time frame: Up to 2 hours after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author
Related trials for Lactium
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactium in people with Lactium and Emergence Agitation, 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 13 Jan 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of emergence agitation (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 13 Jan 2026.