Preemptive Oral Lactium to Prevent Emergence Agitation

NCT07172594 | Completed

• 1 other identifier: 36264PR1306/7/25
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lactium; Emergence Agitation; Adenotonsillectomy

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 1 hour after surgery.

Secondary Outcomes (6)

• Parental separation anxiety

  Perioperative

• Mask Acceptance Score

  Perioperative

• Postoperative pain

  Up to 1 hour after surgery.

• Total dose of rescue fentanyl

  Up to 1 hour after surgery.

• Pediatric Anesthesia Emergence Delirium scale scores

  Up to 1 hour after surgery.

Study Arms (2)

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.

Drug: Lactium

Control group

PLACEBO COMPARATOR

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

Other: Placebo control

Interventions

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.

Lactium group

Placebo control OTHER

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

Control group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesiology, surgical intensive care and pain medicine

Model Details: Parallel assignment

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: September 22, 2025
• Primary Completion: January 8, 2026
• Study Completion: January 8, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available upon a reasonable request from the corresponding author after the end of the study for 1 year
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)