Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia

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

Inclusion Criteria:

* Subject over 7 and under 18 years of age
* Subjects who are scheduled for surgery
* Subject who will be under general anesthesia
* Subject able to complete a self-questionnaire in French

Exclusion Criteria:

* Subject who has already participated in the pediaPREM study
* Subject with a treated anxiety disorder
* Subject with cognitive disorders
* Subject suffering from chronic pain (outside the operated area)
* Subject with ADD (Attention Deficit Disorder) with or without hyperactivity, with or without treatment
* Subject suffering from mental retardation
* Subjects receiving psychotropic treatment
* Subject whose intervention could reduce the ability to complete a self-questionnaire (neurosurgery etc.)
* Subject with a contra-indication to midazolam and its excipients
* Subject with a contra-indication to dexmedetomidine and its excipients
* Subjects who need to receive intravenous alpha agonist in perioperative
* Subjects requiring emergency intervention
* Subjects requiring preoperative hypnosis
* Subject 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 management
* Pregnant or breastfeeding woman
* Subject whose two parents have not signed a written informed consent
* Subjects who are not affiliated with or benefiting from a social security plan

Conditions2

Interventions2

Related trials

• Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia — Second Affiliated Hospital of Wenzhou Medical University
• Dexamethasone vs Dexmedetomidine for iPACK + ACB in TKA — Poznan University of Medical Sciences
• Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve (PECS) Block — Fayoum University
• Dexmedetomidinine in the Prevention of Postoperative Delirium in the Intensive Care Unit After Cardiac Surgery — University of Novi Sad
• Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect — Alexandria University
• Effect of Dexmedetomidine on Microsurgery Reconstruction in Cancer Patient — Dharmais National Cancer Center Hospital
• Intranasal Dexmedetomidine vs Oral Midazolam for Premedication in Pediatric Surgery — Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
• Mental Health After Dexmedetomidine for Electrical Storm — Ottawa Heart Institute Research Corporation

Browse More Trials