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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,000
45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Midazolam , by a blinded nurse.
45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Dexmedetomidine , by a blinded nurse.
45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Grenadine Syrup, by a blinded nurse.
Uhmontpellier
Montpellier, France
RECRUITINGEVANpedia Score
To evaluate patient experience of the perioperative and post-operative period
Time frame: from the day of surgery up to the day one after surgery
VAS-anxiety Scores
To evaluate the perioperative level of anxiety thanks to the Visual Analogue Scale (VAS)
Time frame: from preoperative period up to 6 postoperative month
Postoperative waking delay
Time to wake up after surgery (minutes) to evaluate the delay emergence from anesthesia
Time frame: from the end of the surgery up to the exit of the recovery room
Modified Brice questionnaire Score
To evaluate postoperative amnesia after anesthesia
Time frame: from the day of surgery up to 1 day
Post Hospitalization Behavior Scores
To evaluate changes of behavioral (appetite, sleep, sociability) after surgery
Time frame: 15 postoperative days
quality of life
to evaluate the impact of the perioperative experience on the long-term experience
Time frame: 6 postoperative months
neuropathic pain
to evaluate the percentage of patients with long-term neuropathic pain
Time frame: 6 postoperative month
FPS-r scores
To evaluate the Postoperative level of pain thanks to the Faces Pain Scale-revised (FPS-r)
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Time frame: from the end of the surgery up to 6 post-operative month
Quality of life PedsQL
The quality of life will be measured by PedsQL in order to evaluate the impact of the perioperative experience on the long-term experience. The 23 questions cover 4 different domains: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items) and academic functioning (5 items). The parent questionnaire assesses parents' perceptions of their child's health-related quality of life. On the PedsQL Generic Core Scales, for ease of interpretability, items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life).
Time frame: Up to 6 months post-operatively