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NCT05681572
Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia
Conditions: Anesthesia
Sex: All
Ages: 7 Years – 18 Years
Phase: PHASE3
Enrollment: 1000
Sponsor: University Hospital, Montpellier
Location: France
Summary
Children undergoing general anesthesia for surgery commonly need sedative and anxiolytic premedication but little clinical evidence supports is benefit for children older than 7 years old.The aim of this prospective randomized clinical trial is to assess the impact of pharmacologic premedication on perioperative children experience.
Eligibility Criteria
Inclusion Criteria:Subject over 7 and under 18 years of ageSubjects who are scheduled for surgerySubject who will be under general anesthesiaSubject able to complete a self-questionnaireExclusion Criteria:Subject with a treated anxiety disorderSubject suffering from cognitive disordersSubject suffering from chronic pain (outside the operated area)Subject with ADD (Attention Deficit Disorder) with or without hyperactivity, with or without treatmentSubject suffering from mental retardationSubjects receiving psychotropic treatmentSubject whose intervention could reduce the ability to complete a self-questionnaire (neurosurgery etc.)Subject with a contra-indication to midazolam and its excipientsSubject with a contra-indication to dexmedetomidine and its excipientsSubjects who need to receive alpha agonist in perioperative (clonidine, dexmedetomidine...)Subjects requiring emergency interventionSubjects requiring preoperative hypnosisSubject who needs general anesthesia for diagnostic purposes (biopsy, etc...)Subject having had a surgical intervention in the month preceding the inclusion.Subject who will have an iterative surgical intervention within 15 days (removal of material, burns etc...)Subjects who are scheduled for surgery as part of oncology managementPregnant or breastfeeding womanSubject whose two parents have not signed a written informed consentSubjects who are not affiliated with or benefiting from a social security plan
Source: ClinicalTrials.gov (NCT05681572). StuddyBuddy aggregates publicly available trial information.