Tablet-based Interactive Distraction Preoperative Anxiety in Children: A Randomized Controlled Trial (TABLET)

Universidad de Valparaiso

Status: Unknown

Conditions: Children Under General Anaesthesia

Treatments: Drug: Midazolam; Device: TIBD

Study type: Interventional

Funder types: Other

Identifiers

NCT03531359

UV-1-2018

Details and patient eligibility

About

Children develop anxiety during the induction of anaesthesia and video-games might reduce or alleviate it. The investigators intend to conduct a clinical trial to study the effect of tablet-based interctive games on alleviating preoperative anxiety.

Full description

It is estimated that 50% of children may suffer preoperative anxiety. They have a higher risk of generating postanesthetic delirium and behavioral changes in the postoperative period up to 67% of cases.

For the management of preoperative anxiety there are pharmacological and non-pharmacological treatments. Within the first group there's the use of benzodiazepines of short half life like midazolam, however, the use of this medication is not exempt of risks such as paradox reactions, respiratory depression, among others. This is why the non pharmacological mesures have taken force and every day there is more evidence regarding its effectiveness.

There are no reports in Chile or latin america regarding the use of this tools, this is why the investigators designed this study to prove the effectiveness of audiovisual distraction measures in reducing preparatory anxiety compared to premeditation with midazolam.

Enrollment: 112 estimated patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Children aged 2-10 years, under major surgery ambulatory program at Hospital Carlos Van Buren, with no contraindication for the use of midazolam.

Exclusion criteria

Patients with cognitive impairment or sensory deficit Patients with previous history of major surgery will also be excluded Patients with myastenia "Hard airway" History of paroxystic reaction to benzodiazepines Attentional deficit hyperactivity disorder Sleep aphnea Full stomach Adenotonsillar hypertrophy Respiratory acute infections

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups

TIBD Tablet-based video distraction

Experimental group

Description:

Children will receive of tablet-based interctive games in preoperatory room

Treatment:

Device: TIBD

Midazolam

Active Comparator group

Description:

Children will be premedicated with usual treatmente (midazolam)

Treatment:

Drug: Midazolam