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Interactive Tablet Compared to Oral Midazolam as Premedication in Preoperative Anxiety in Children

NCT04049201 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2019-08-08

No results posted yet for this study

Summary

preoperative anxiety is an undesirable outcome in pediatric surgical patients.It can lead to behavioral trouble such as enuresis, apathy and sleep disorders.

to prevent this anxiety,many tools can be used for premedication like pharmacological:Midazolam, clonidine, hydroxysine or non pharmacological tools such as parental presence,hypnosis and interactive tablet.

the purpose of the study is to compare the effect of interactive tablet to oral midazolam.on preoperative anxiety in children prior to elective surgery

Conditions

Interventions

PROCEDURE

elective surgery

investigators will compare the effect of interactive tablet on preoperative anxiety in children to the effect ofMidazolam in elective surgery

DRUG

Midazolam

Oral Midazolam

DEVICE

Interactive Tablet

interactive Tablet containing many cartoon's videos

Sponsors & Collaborators

  • Hôpital d'enfants Béchir-Hamza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-04
Primary Completion
2019-05-19
Completion
2019-05-19

Countries

  • Tunisia

Study Locations

More Related Trials

Entities

Diseases

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 NCT04049201 on ClinicalTrials.gov