Lactium premedication to see if it prevents emergence agitation after adenotonsillectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, dose-finding study uses a biased coin sequential allocation to identify the oral Lactium dose that prevents emergence agitation in 90% of children undergoing adenotonsillectomy with sevoflurane anesthesia. Lactium is a milk-derived peptide thought to act on GABA-A receptors to reduce anxiety and stress. The trial will enroll children aged 3–12 with ASA I–II and will compare escalating doses to determine the ED90. The primary goal is to establish a safe and effective premedication dose prior to surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Children aged 3 to 12 years
* American Society of Anesthesiologist (ASA) Status I or II
* Planned for an adenotonsillectomy procedure under sevoflurane general anesthesia.

Exclusion Criteria:

* 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.

Where it's running

• Tanta University Hospitals
  Tanta, Gharbia Governorate, Egypt Recruiting

Study contacts

• Study coordinator: Osama M Rehab, MD
• Email: osamarehab@med.tanta.edu.eg
• Phone: 01095210806

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Oral melatonin versus nebulized dexmedetomidine to reduce emergence agitation after adenotonsillectomy in children

  We will test whether giving oral melatonin or nebulized dexmedetomidine before anesthesia better prevents children aged 3–7 from becoming agitated as they wake after adenotonsillectomy.

  Recruiting Tanta University · Tanta, El-Gharbia · NCT07345715

• Perfusion Index to Measure Postoperative Pain in Kids After Adenotonsillectomy

  This study tests whether the perfusion index can reliably reflect pain levels in children aged 1–12 after adenotonsillectomy, comparing standard care with an added glossopharyngeal nerve block.

  Recruiting Istanbul University · Istanbul, Istanbul · NCT07915804

• Postoperative Pain After Pediatric Adenotonsillectomy: Ibuprofen Plus Tylenol vs Ketorolac Plus Tylenol

  This observational study will see if teens (13-18) who have adenotonsillectomy and take acetaminophen with ibuprofen or acetaminophen with ketorolac after discharge experience different levels of pain and recovery.

  Recruiting Baylor College of Medicine · Houston, Texas · NCT07672418

• Oral vs IV Magnesium for Emergence Delirium in Children after Adenotonsillectomy

  This trial tests whether giving magnesium by mouth before surgery or by IV during surgery can reduce emergence delirium in children aged 4–7 undergoing adenotonsillectomy with sevoflurane anesthesia.

  Recruiting Phase 2/3 Tanta University · Tanta, Gharbia Governorate · NCT07655817

• Intranasal dexmedetomidine versus oral midazolam for premedication in children having elective inguinal or urological surgery

  This trial will test whether intranasal dexmedetomidine or oral midazolam works better to calm children aged 2–10 before elective inguinal or urological surgery.

  Recruiting Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Diyarbakır, Outside of the US · NCT07565116

• Repeated verbal orientation reminders to reduce emergence agitation after general anesthesia

  We'll try prerecorded verbal orientation reminders through headphones to see if they reduce wake-up agitation in adults (18–70) having elective laparoscopic abdominal surgery with sevoflurane general anesthesia.

  Recruiting Shaukat Khanum Memorial Cancer Hospital & Research Centre · Lahore, Punjab Province · NCT07510516

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.