Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia
NCT ID: NCT05681572
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1000 participants
INTERVENTIONAL
2023-04-18
2027-10-18
Brief Summary
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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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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
For the premedication group, children are randomly allocated to be premedicated with either with the midazolam or dexmedetomidine (2 sup-groups).
TREATMENT
DOUBLE
Only the nurse involved in the preparation of experimental treatments is not blinded. She will not be involved in the follow-up of the study.
Study Groups
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Premedication Group (Midazolam)
Midazolam (0,5 mg/kg; max 10 mg), oral administration, 45 minutes prior entering in the operating room
Midazolam
45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Midazolam , by a blinded nurse.
Premedication Group (Dexmedetomidine)
Dexmedetomidine (2 µg/kg), oral administration, 45 minutes prior entering in the operating room
Dexmedetomidine
45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Dexmedetomidine , by a blinded nurse.
Placebo Group
grenadine syrup (3 mL), oral administration, 45 minutes prior entering in the operating room
Placebo
45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Grenadine Syrup, by a blinded nurse.
Interventions
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Midazolam
45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Midazolam , by a blinded nurse.
Dexmedetomidine
45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Dexmedetomidine , by a blinded nurse.
Placebo
45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Grenadine Syrup, by a blinded nurse.
Eligibility Criteria
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Inclusion Criteria
* 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 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
7 Years
18 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Christophe DADURE, PHD
Role: STUDY_DIRECTOR
Hospital of Montpellier
Locations
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Uhmontpellier
Montpellier, , France
Countries
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Central Contacts
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Facility Contacts
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Sophie BRINGUIER, PHARM D, phD
Role: primary
Other Identifiers
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2022-501124-23-00
Identifier Type: OTHER
Identifier Source: secondary_id
RECHMPL21_0354
Identifier Type: -
Identifier Source: org_study_id