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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Midazolam

    Drug

    45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Midazolam , by a blinded nurse.

  • Dexmedetomidine

    Drug

    45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Dexmedetomidine , by a blinded nurse.

  • Placebo

    Drug

    45 minutes before entering the operating room, patient receives the oral treatment according to their randomization arm, here Grenadine Syrup, by a blinded nurse.

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: Premedication Group (Midazolam)Experimental treatment 1 intervention
Group B: Premedication Group (Dexmedetomidine)Experimental treatment 1 intervention
Group C: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

EVANpedia Score

To evaluate patient experience of the perioperative and post-operative period

Time frame
from the day of surgery up to the day one after surgery

Secondary outcomes

1

VAS-anxiety Scores

To evaluate the perioperative level of anxiety thanks to the Visual Analogue Scale (VAS)

Time frame
from preoperative period up to 6 postoperative month
2

Postoperative waking delay

Time to wake up after surgery (minutes) to evaluate the delay emergence from anesthesia

Time frame
from the end of the surgery up to the exit of the recovery room
3

Modified Brice questionnaire Score

To evaluate postoperative amnesia after anesthesia

Time frame
from the day of surgery up to 1 day
4

Post Hospitalization Behavior Scores

To evaluate changes of behavioral (appetite, sleep, sociability) after surgery

Time frame
15 postoperative days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Source ClinicalTrials.gov
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