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NCT07894484
Lactium Premedication to Prevent Emergence Agitation
Conditions: Lactium, Premedication, Emergence Agitation, Adenotonsillectomy, Dose Finding Study
Sex: All
Ages: 3 Years – 12 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 40
Sponsor: Tanta University
Location: Tanta University Hospitals Tanta Gharbia Governorate
Summary
This biased coin sequential allocation, dose finding study will be conducted to determine the effective dose of oral lactium in 90% of children (ED90) for prevention of emergence agitation during recovery from adenotonsillectomy.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07894484). StuddyBuddy aggregates publicly available trial information.