Clinical trial NCT05681572: Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia
Official title: " Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia " The pediaPREM Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Anesthesia
Keywords: children premedication
anesthesia
children perioperative experience
anxiety
sedation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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

Eligibility criteria: 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 in French

Exclusion Criteria:

* 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

Primary outcomes:
measure: EVANpedia Score
timeFrame: from the day of surgery up to the day one after surgery
Secondary outcomes:
measure: VAS-anxiety Scores
timeFrame: from preoperative period up to 6 postoperative month
measure: Postoperative waking delay
timeFrame: from the end of the surgery up to the exit of the recovery room
measure: Modified Brice questionnaire Score
timeFrame: from the day of surgery up to 1 day
measure: Post Hospitalization Behavior Scores
timeFrame: 15 postoperative days
measure: quality of life
timeFrame: 6 postoperative months
measure: neuropathic pain
timeFrame: 6 postoperative month
measure: FPS-r scores
timeFrame: from the end of the surgery up to 6 post-operative month
measure: Quality of life PedsQL
timeFrame: Up to 6 months post-operatively
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: Hospital of Montpellier
name: Christophe DADURE, PHD
role: STUDY_DIRECTOR
References: