Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05681572 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: pediaPREM
StatusRecruiting
PhasePhase 3
Started2023-04-18
View on ClinicalTrials.gov ↗

Amendment history

2026-07-16
Study Status, Contacts/Locations v4
Primary completion date2026-10-18→2027-10-18
Study sitesdetails revised at 1 of 1 site
2024-12-13
Study Status, Outcome Measures, Eligibility v3
Primary completion date2026-02-01→2026-10-18
Completion date2026-03-01→2027-10-18
Eligibility criteriarevised
[...] ral anesthesia Subject able to complete a self-questionnaire in French Exclusion Criteria: Subject who has already participated in [...] aPREM study Subject with a treated anxiety disorder Subject suffering fromwith cognitive disorders Subject suffering from chronic pain (ou [...]
Secondary endpoints5 to 8 entries
quality of life neuropathic pain Quality of life PedsQL
2023-11-21
Study Status, Eligibility v2
Eligibility criteria+40 characters
[...] t 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 fr [...] edetomidine and its excipients Subjects who need to receive intravenous alpha agonist in perioperative (clonidine, dexmedetomidine...) Subjects requiring emergency intervention Subjects requirin [...]
2023-04-19
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-02-01→confirmed 2023-04-18
Study sitesdetails revised at 1 of 1 site
2022-12-27
Original filing
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.
Trial Details
NCT Number NCT05681572
Lead Sponsor University Hospital, Montpellier
Conditions Anesthesia
Enrollment 1,000 participants
Start Date 2023-04-18
Primary Completion 2027-10-18 (estimated)
Study Completion 2027-10-18 (estimated)
Updated on ClinicalTrials.gov 2026-07-17