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โ† Trials
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Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia

RecruitingPhase 3Ages 7 Years - 18 YearsAllUniversity Hospital, Montpellier
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 * Subject with a treated anxiety disorder * Subject with cognitive disorders * Subject suffering from chronic pain (outside the operated area) * Subject with ADD (Attention Deficit Disorder) with or without hyperactivity, with or without treatment * Subject suffering from mental retardation * Subjects receiving psychotropic treatment * Subject whose intervention could reduce the ability to complete a self-questionnaire (neurosurgery etc.) * Subject with a contra-indication to midazolam and its excipients * Subject with a contra-indication to dexmedetomidine and its excipients * Subjects who need to receive intravenous alpha agonist in perioperative * Subjects requiring emergency intervention * Subjects requiring preoperative hypnosis * Subject who needs general anesthesia for diagnostic purposes (biopsy, etc...) * Subject having had a surgical intervention in the month preceding the inclusion. * Subject who will have an iterative surgical intervention within 15 days (removal of material, burns etc...) * Subjects who are scheduled for surgery as part of oncology management * Pregnant or breastfeeding woman * Subject whose two parents have not signed a written informed consent * Subjects who are not affiliated with or benefiting from a social security plan
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What it tests

  • Midazolam
  • Dexmedetomidine
  • Placebo
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Where

1 site
Uhmontpellier
Montpellier, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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