NCT07172594

Preemptive Oral Lactium to Prevent Emergence Agitation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 3 Years – 7 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	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.
OTHER	Placebo control	50 ml water added to it powdered vanilla flavor will be given to cases 2 hours before surgery.

Timeline

• Start date: 2025-09-22
• Primary completion: 2026-01-08
• Completion: 2026-01-08
• First posted: 2025-09-15
• Last updated: 2026-01-13

Locations

1 site across 1 country: Egypt