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NCT Number: NCT07172594

Preemptive Oral Lactium to Prevent Emergence Agitation

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.

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Key information

Conditions

Lactium Adenotonsillectomy Confusion Delirium Emergence Agitation Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both gender
  • 4 to 7 years age
  • American Society of Anesthesiologists (ASA) Physical Status I or II
  • Scheduled for adenotonsillectomy surgery under sevoflurane anesthesia

Exclusion criteria

  • 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

Treatment and study plan

Lactium

Drug

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 control

Other

50 ml water added to it powdered vanilla flavor will be given to cases 2 hours before surgery.

Primary outcomes

  1. 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

Secondary outcomes

  1. Parental separation anxiety

    Time frame: Perioperative

    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

  2. Mask Acceptance Score

    Time frame: Perioperative

    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

  3. Postoperative pain

    Time frame: Up to 1 hour after surgery.

    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.

  4. Total dose of rescue fentanyl

    Time frame: Up to 1 hour after surgery.

    Fentanyl will be given for agitation or pain

  5. Pediatric Anesthesia Emergence Delirium scale scores

    Time frame: Up to 1 hour after surgery.

    severity of agitation will be assessed by Pediatric Anesthesia Emergence Delirium scale.

  6. Number of patients who will develop postoperative nausea and vomiting.

    Time frame: Up to 2 hours after surgery.

    Any episodes of nausea and vomiting will be recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Preemptive Oral Lactium Supplement to Prevent Emergence Agitation in Children Undergoing Adenotonsillectomy: A Randomized Placebo Controlled Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2025
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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