« Effect of sedative and anxiolytic sedation on children experience after general anesthesia » PEDIA_prem study.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Montpellier

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

Trial duration

18 Apr 2023 → ongoing

Decision date (initial)

2022-10-14

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

DGOS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Prophylaxis, Therapy

The aim of this prospective randomized clinical trial is to assess the impact of pharmacologic premedication on perioperative children experience.

Secondary objectives 8

1. To compare two by two the three groups on the perioperative experience measured by the EVANpédia questionnaire at 24 hours postoperatively (or before discharge from the hospital for children operated on as an outpatient).
2. To compare two by two the three groups on the cooperation of the child before the induction of anesthesia as well as the need for possible rescue sedation in case of extreme agitation will be noted
3. To compare two by two the three groups on the intraoperative hemodynamic effects (blood pressure, heart rate, etc.) are collected on the anesthesia sheet in routine practice. The number of hypotension or bradycardia (lower than the preoperative reference measurements) and their treatment will be compared.
4. To compare two by two the three groups on the evolution of perioperative anxiety measured by the EVA-anxiety in self-evaluation from inclusion to the end of the follow-up at 24 hours postoperatively (or discharge).
5. To compare two by two the three groups on the postoperative pain measured by the FPS-R self-report scale and the amount of rescue analgesics administered in the recovery room, at D0 and at D1 postoperatively (for those hospitalized).
6. Postoperative cognitive status will be assessed by time to recovery and agitation of the child in the recovery room. Amnesia will be measured at 24 hours postoperatively (or before discharge from hospital for ambulatory children) by items from the Brice questionnaire but adapted to the child
7. In order to measure the place of premedication according to the anxious personality, this score and its dimensions will also be compared by anxiety subgroup (non-anxious subgroup if STAIC < 34 and anxious subgroup if STAIC ≥ 34).
8. Analyses will be conducted to identify factors that may influence the child's experience (anxiousness, parental anxiety, medical and surgical history, indication and surgical invasiveness).

Conditions and MedDRA coding

General anesthesia and sedative and anxiolytic sedation

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Children older than 7 years old and younger than 18 years old
2. Subject to undergo surgery under general anesthesia
3. Subject able to complete a self-questionnaire
4. Subject requiring intervention under general anesthesia

Exclusion criteria 19

1. Subject suffering from anxiety disorders
2. Subject who needs to undergo an emergency procedure
3. Subjects who need preoperative hypnosis
4. Subject who needs general anesthesia for diagnostic purposes (biopsy, etc...)
5. Subjects who need a neurosurgical intervention or had a surgical intervention in the month preceding inclusion.
6. Subject who will have an iterative surgical intervention within 15 days (removal of material, burns, etc.)
7. Subjects who are scheduled for surgery as part of oncology management
8. Pregnant or breastfeeding woman
9. Subject whose parent has not signed a written informed consent
10. Subject who is not affiliated with or benefiting from a social security plan
11. Subject suffering from cognitive disorders
12. Subject suffering from chronic pain
13. Subject with ADD (Attention Deficit Disorder) with or without hyperactivity; with or without treatment
14. Subjects suffering from mental retardation
15. Subjects receiving psychotropic treatment
16. Subjects whose ability to complete a self-administered questionnaire may be impaired by the intervention
17. Subject with a contraindication to midazolam or to dexmedetomidine
18. Subjects requiring peri-operative alpha agonist
19. Subject who has already participated in the pediaPREM study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint was the EVANpedia perioperative experience score and its sub-dimensions completed by the children (self-report) at 24 hours postoperatively or before hospital discharge for children managed as outpatients.

Secondary endpoints 8

1. Perioperative anxiety
2. Haemodynamic changes (Tachycadia, Bradycardia hypotension) during intervention, postoperative pain
3. Sedation and time to extubation
4. Rate of recovery
5. Amnesia and cognitive impairment
6. Changes of behavioral
7. All perioperative complications between the 3 groups
8. Quality of life

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Montpellier

Sponsor organisation

Centre Hospitalier Universitaire De Montpellier

Address

191 Avenue Du Doyen Gaston Giraud

City

Montpellier Cedex 5

Postcode

34295

Country

France

Scientific contact point

Organisation

University Hospital Of Montpellier

Contact name

Sophie BRINGUIER

Public contact point

Organisation

University Hospital Of Montpellier

Contact name

Sophie BRINGUIER

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications