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

Anesthesia Clinical Trial

— pediaPREM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05681572
• Other study ID #: RECHMPL21_0354
• Secondary ID: 2022-501124-23-0
• Status: Recruiting
• Phase: Phase 3
• Start date: April 18, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: November 2023
• Source: University Hospital, Montpellier
• Contact: Sophie BRINGUIER, PHD
• Phone: 0467338661
• Email: s-bringuierbranchereau[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 1, 2026
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EVANpedia Score	To evaluate patient experience of the perioperative period	from the day of surgery up to 1 day
Secondary	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
Secondary	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
Secondary	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
Secondary	Modified Brice questionnaire Score	To evaluate postoperative amnesia after anesthesia	from the day of surgery up to 1 day
Secondary	Post Hospitalization Behavior Scores	To evaluate changes of behavioral (appetite, sleep, sociability) after surgery	15 postoperative days