Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia
- Registration Number
- NCT05681572
- Lead Sponsor
- University Hospital, Montpellier
- Brief 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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Group Placebo grenadine syrup (3 mL), oral administration, 45 minutes prior entering in the operating room Premedication Group (Midazolam) Midazolam Midazolam (0,5 mg/kg; max 10 mg), oral administration, 45 minutes prior entering in the operating room Premedication Group (Dexmedetomidine) Dexmedetomidine Dexmedetomidine (2 µg/kg), oral administration, 45 minutes prior entering in the operating room
- Primary Outcome Measures
Name Time Method EVANpedia Score from the day of surgery up to the day one after surgery To evaluate patient experience of the perioperative and post-operative period
- Secondary Outcome Measures
Name Time Method VAS-anxiety Scores from preoperative period up to 6 postoperative month To evaluate the perioperative level of anxiety thanks to the Visual Analogue Scale (VAS)
Postoperative waking delay from the end of the surgery up to the exit of the recovery room Time to wake up after surgery (minutes) to evaluate the delay emergence from anesthesia
Modified Brice questionnaire Score from the day of surgery up to 1 day To evaluate postoperative amnesia after anesthesia
Post Hospitalization Behavior Scores 15 postoperative days To evaluate changes of behavioral (appetite, sleep, sociability) after surgery
quality of life 6 postoperative months to evaluate the impact of the perioperative experience on the long-term experience
neuropathic pain 6 postoperative month to evaluate the percentage of patients with long-term neuropathic pain
FPS-r scores from the end of the surgery up to 6 post-operative month To evaluate the Postoperative level of pain thanks to the Faces Pain Scale-revised (FPS-r)
Quality of life PedsQL Up to 6 months post-operatively 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).
Trial Locations
- Locations (1)
Uhmontpellier
🇫🇷Montpellier, France