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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501124-23-00
Acronym
RECHMPL21_0354
Enrollment
1000
Registered
2022-10-14
Start date
2023-04-18
Completion date
Unknown
Last updated
2025-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General anesthesia and sedative and anxiolytic sedation

Brief summary

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.

Detailed description

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

Interventions

DRUGsolution à diluer pour perfusion
DRUGthe placebo will be the grenadine syrup that is usually used in anesthesia and resuscitation departments.

Sponsors

Centre Hospitalier Universitaire De Montpellier
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Perioperative anxiety, Haemodynamic changes (Tachycadia, Bradycardia hypotension) during intervention, postoperative pain, Sedation and time to extubation, Rate of recovery, Amnesia and cognitive impairment, Changes of behavioral, All perioperative complications between the 3 groups, Quality of life

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026