← Back to all trials
Not Yet Recruiting
NCT07928947
Lactium Versus Midazolam Premedication on Postoperative Negative Behavioral Changes
Conditions: Lactium, Midazolam, Behavior, Adenotonsillectomy
Sex: All
Ages: 3 Years – 12 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 180
Sponsor: Tanta University
Location: Tanta University Hospitals Tanta Gharbia Governorate
Summary
This prospective randomized double-blind placebo-controlled study will be conducted to compare the effects of preoperative oral lactium and midazolam on the incidence of postoperative negative behavioral changes in young children undergoing adenotonsillectomy.
Eligibility Criteria
Inclusion Criteria:
* Children aged 3 to 12 years.
* American Society of Anesthesiologists (ASA) Physical Status I or II.
* scheduled for adenotonsillectomy under sevoflurane general 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.
* Allergy to midazolam or lactose.
Source: ClinicalTrials.gov (NCT07928947). StuddyBuddy aggregates publicly available trial information.
