Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia
ConditionAnesthesia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age7-18
SponsorUniversity Hospital, Montpellier
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Midazolam
- Dexmedetomidine
- Placebo
Treatment groups
1,000 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov