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Handheld-multimedia Versus Oral Midazolam in Pediatric on Perioperative Anxiety

NCT04273035 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-05-04

No results posted yet for this study

Summary

The first goal of this study is to compare the efficacy and safety between anxiolysis by multimedia-distraction with an IPAD versus anxiolysis by premedication with midazolam prior to the induction. Secondly to evaluate the need for midazolam-premedication in pediatric day-care patients induced by inhalational anesthesia.

Conditions

  • Perioperative Anxiety
  • Preanesthetic Medication
  • Inhalation Anesthesia
  • Ambulatory Surgery
  • Tonsillectomy
  • Circumcision
  • Dental Care

Interventions

DRUG

Midazolam oral solution

Oral Buccolam

DEVICE

IPAD

Playing any game, film, clip or puzzle on a tablet till after induction of anesthesia

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Alex Van Hoorn, MD · Resident of department of Anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2021-12-31
Completion
2022-02-28

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04273035 on ClinicalTrials.gov