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

Study Overview
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Brief Summary
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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.

Detailed Description
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Surgery is a stressful experience in children with preoperative and postoperative anxiety. For preschooler undergoing surgery, anxiety is the highest in the preoperative period. Most of studies have been conducted on young children (< 7yrs old) to show the relationship between preoperative anxiety and emergence of delirium and postoperative maladaptive behavioral changes. Sedative and anxiolytic medication is frequently used in children to reduce anxiety and postoperative maladaptive experiences. Nevertheless, little clinical evidence supports is benefit for children older than 7 years. Treating anxiety is not necessarily associated with better experience in all children because premedication causes postoperative sedation, amnesia and cognitive impairment. The aim of this prospective randomized clinical trial is to assess the impact of pharmacologic premedication on perioperative children experience using self-report questionnaire. Patients are randomized to 2 groups to received pharmacologic premedication or placebo. For the premedication group, children are randomly allocated to be premedicated with either with the midazolam or dexmedetomidine

Official Title
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 Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia  The pediaPREM Study.

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Midazolam
* Drug: Dexmedetomidine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Subject who has already participated in the pediaPREM study Subject with a treated anxiety disorder Subject suffering from 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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are randomized to 2 groups to received pharmacologic premedication or placebo. For the premedication group, children are randomly allocated to be premedicated with either with the midazolam or dexmedetomidine (2 sup-groups).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Premedication Group (Midazolam)<br>Midazolam (0,5 mg/kg; max 10 mg), oral administration, 45 minutes prior entering in the operating room | Drug: Midazolam<br>* 45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Midazolam , by a blinded nurse.<br>|
| Experimental: Premedication Group (Dexmedetomidine)<br>Dexmedetomidine (2 µg/kg), oral administration, 45 minutes prior entering in the operating room | Drug: Dexmedetomidine<br>* 45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Dexmedetomidine , by a blinded nurse.<br>|
| Placebo Comparator: Placebo Group<br>grenadine syrup (3 mL), oral administration, 45 minutes prior entering in the operating room | Drug: Placebo<br>* 45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Grenadine Syrup, by a blinded nurse.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EVANpedia Score | To evaluate patient experience of the perioperative period | from the day of surgery up to 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS-anxiety Scores | To evaluate the perioperative level of anxiety thanks to the Visual Analogue Scale (VAS) | from preoperative period up to 15 postoperative days | 
| FPS-r scores | To evaluate the Postoperative level of pain thanks to the Faces Pain Scale-revised (FPS-r) | from the end of the surgery up to 15 postoperative days | 
| Postoperative waking delay | Time to wake up after surgery (minutes) to evaluate the delay emergence from anesthesia | from the end of the surgery up to the exit of the recovery room | 
| Modified Brice questionnaire Score | To evaluate postoperative amnesia after anesthesia | from the day of surgery up to 1 day | 
| Post Hospitalization Behavior Scores | To evaluate changes of behavioral (appetite, sleep, sociability) after surgery | 15 postoperative days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anesthesia, children premedication, children perioperative experience, anxiety, sedation