« Effect of sedative and anxiolytic sedation on children experience after general anesthesia » PEDIA_prem study.

INTERVENTION: Product Name: MIDAZOLAM VIATRIS 5 mg/ml, solution injectable ou rectale,Product Code: PRD9490081,Pharmaceutical Form: SOLUTION FOR INJECTION/INFUSION,Other descriptive name: ,Strength: Midazolam 5mg,Product Name: the placebo will be the grenadine syrup that is usually used in anesthesia and resuscitation departments.,Product Code: N/A,Pharmaceutical Form: N/A,Other descriptive name: N/A,Strength: N/A,Pharmaceutical form of the placebo: N/A,Product Name: DEXMEDETOMIDINE EVER PHARMA 100 microgrammes/mL, solution à diluer pour perfusion,Product Code: PRD7133322,Pharmaceutical Form: SOLUTION FOR INFUSION,Other descriptive name: ,Strength: Dexmedetomidine 4µg CONDITION: General anesthesia and sedative and anxiolytic sedation Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03]‐Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]‐Surgical Procedures, Operative [E04] SECONDARY OUTCOME: Secondary end point(s):All perioperative complications between the 3 groups Secondary end point(s):Amnesia and cognitive impairment Secondary end point(s):Changes of behavioral Secondary end point(s):Haemodynamic changes (Tachycadia, Bradycardia hypotension) during intervention, postoperative pain Secondary end point(s):Perioperative anxiety Secondary end point(s):Rate of recovery Secondary end point(s):Sedation and time to extubation INCLUSION CRITERIA: Children older than 7 years old and younger than 18 years old,Subject to undergo surgery under general anesthesia,Subject able to complete a self‐questionnaire PRIMARY OUTCOME: Main Objective:The aim of this prospective randomized clinical trial is to assess the impact of pharmacologic premedication on perioperative children experience. Primary end point(s):The primary endpoint was the EVANpedia perioperative experience score and its sub‐dimensions completed by the children (self‐report) at 24 hours postoperatively or before hospital discharge for children managed as outpatients. Secondary Objective:To compare two by two the three groups on the perioperative experience measured by the EVANpédia questionnaire at 24 hours postoperatively (or before discharge from the hospital for children operated on as an outpatient).,To compare two by two the three groups on the cooperation of the child before the induction of anesthesia as well as the need for possible rescue sedation in case of extreme agitation will be noted,To compare two by two the three groups on the intraoperative hemodynamic effects (blood pressure, heart rate, etc.) are collected on the anesthesia sheet in routine practice. The number of hypotension or bradycardia (lower than the preoperative reference measurements) and their treatment will be compared.,To compare two by two the three groups on the evolution of perioperative anxiety measured by the EVA‐anxiety in self‐evaluation from inclusion to the end of the follow‐up at 24 hours postoperatively (or discharge).,To compare two by two the three groups on the postoperative pain measured by the FPS‐R self‐report scale and the amount of rescue analgesics administered in the recovery room, at D0 and at D1 postoperatively (for those hospitalized).,Postoperative cognitive status will be assessed by time to recovery and agitation of the child in the recovery room. Amnesia will be measured at 24 hours postoperatively (or before discharge from hospital for ambulatory children) by items from the Brice questionnaire but adapted to the child,In order to measure the place of premedication according to the anxious personality, this score and its dimensions will also be compared by anxiety subgroup (non‐anxious subgroup if STAIC < 34 and anxious subgroup if STAIC = 34).,Analyses will be conducted to identify factors that may influence the child's experience (anxiousness, parental anxiety, medical and surgical history, indication and surgical invasiveness).