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

Recruiting Phase 3 Interventional Study
Anesthesia
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
7 – 18
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,000 (estimated)
Sponsor
University Hospital, Montpellier · Other
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About This Trial

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 Locations
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Eligibility Criteria
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 * Subj…
Contacts

Sophie BRINGUIER, PHD

0467338661

s-bringuierbranchereau@chu-montpellier.fr

CONTACT