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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Midazolam; Drug: Dexmedetomidine; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sophie BRINGUIER, PHD; Phone Number: +33 0467338661; Email: s-bringuierbranchereau@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Uhmontpellier
    • Contact: Sophie BRINGUIER, PHARM D, phD; Phone Number: +33 0467338661; Email: s-bringuierbranchereau@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Premedication Group (Midazolam); Midazolam (0,5 mg/kg; max 10 mg), oral administration, 45 minutes prior entering in the operating room	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.
Experimental: Premedication Group (Dexmedetomidine); Dexmedetomidine (2 µg/kg), oral administration, 45 minutes prior entering in the operating room	Drug: 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 Comparator: Placebo Group; grenadine syrup (3 mL), oral administration, 45 minutes prior entering in the operating room	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EVANpedia Score	To evaluate patient experience of the perioperative and post-operative period	from the day of surgery up to the day one after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Modified Brice questionnaire Score	To evaluate postoperative amnesia after anesthesia	from the day of surgery up to 1 day
Post Hospitalization Behavior Scores	To evaluate changes of behavioral (appetite, sleep, sociability) after surgery	15 postoperative days
VAS-anxiety Scores	To evaluate the perioperative level of anxiety thanks to the Visual Analogue Scale (VAS)	from preoperative period up to 6 postoperative month
quality of life	to evaluate the impact of the perioperative experience on the long-term experience	6 postoperative months
neuropathic pain	to evaluate the percentage of patients with long-term neuropathic pain	6 postoperative month
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 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).	Up to 6 months post-operatively

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Christophe DADURE, PHD, Hospital of Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Estimated): October 18, 2026
• Study Completion (Estimated): October 18, 2027

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: anesthesia; anxiety; sedation; children premedication; children perioperative experience
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Adjuvants, Anesthesia; Hypnotics and Sedatives; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anesthetics, Intravenous; Anesthetics, General; GABA Modulators; GABA Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: RECHMPL21_0354; 2022-501124-23-00 (Other Identifier: EU CT (European Regulation No. 536/2014))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No