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

NCT05681572 | Recruiting Phase 3 DMC

• 2 other identifiers: RECHMPL21_03542022-501124-23-00
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

children premedication; anesthesia; children perioperative experience; anxiety; sedation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• VAS-anxiety Scores

  from preoperative period up to 6 postoperative month

• Postoperative waking delay

  from the end of the surgery up to the exit of the recovery room

• Modified Brice questionnaire Score

  from the day of surgery up to 1 day

• Post Hospitalization Behavior Scores

  15 postoperative days

• quality of life

  6 postoperative months

Study Arms (3)

Premedication Group (Midazolam)

EXPERIMENTAL

Midazolam (0,5 mg/kg; max 10 mg), oral administration, 45 minutes prior entering in the operating room

Drug: Midazolam

Premedication Group (Dexmedetomidine)

EXPERIMENTAL

Dexmedetomidine (2 µg/kg), oral administration, 45 minutes prior entering in the operating room

Drug: Dexmedetomidine

Placebo Group

PLACEBO COMPARATOR

grenadine syrup (3 mL), oral administration, 45 minutes prior entering in the operating room

Drug: Placebo

Interventions

Midazolam DRUG

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 (Midazolam)

Dexmedetomidine DRUG

45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Dexmedetomidine , by a blinded nurse.

Premedication Group (Dexmedetomidine)

Placebo DRUG

45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Grenadine Syrup, by a blinded nurse.

Placebo Group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 who will have an iterative surgical intervention within 15 days (removal of material, burns etc...)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Midazolam; Dexmedetomidine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Christophe DADURE, PHD

  Hospital of Montpellier

  STUDY DIRECTOR

Central Study Contacts

Sophie BRINGUIER, PHD

CONTACT

0467338661; s-bringuierbranchereau@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Physicians, the nurse responsible for administration, the staff following the patient and the patient will be blinded to randomisation. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 12, 2023
• Study Start: April 18, 2023
• Primary Completion (Estimated): October 18, 2026
• Study Completion (Estimated): October 18, 2027
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

FR (1)