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Not Yet Recruiting 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07894484). StuddyBuddy aggregates publicly available trial information.