Clinical trial

To Compare Pharmacological and Non-Pharmacological Interventions (Use of Technology) For Alleviating Preoperative Anxiety In Children Undergoing General Anesthesia In A Tertiary Care Hospital Of Pakistan: A Randomized Controlled Trial.

Name

2022-7684-21894

Description

The purpose of this study is to find out any beneficial effects of electronic devices over preoperative pharmacological intervention in the preoperative period.

Trial arms

Trial start

2023-03-20

Estimated PCD

2024-03-25

Trial end

2024-04-01

Status

Recruiting

Treatment

iPad®

Use of Technology.

Arms:

Interventional group

Other names:

Tablet

Midazolam

Standard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg).

Arms:

Control group

Size

Primary endpoint

modified Yale Preoperative Anxiety Scale

Day 1

Eligibility criteria

Inclusion Criteria: 1. Children aged between 2 and 12 years old 2. ASA I and II 3. Informed consent signed by parents or legal guardians Exclusion Criteria: 1. Previous exposure to surgery 2. Contraindication to midazolam 3. Patients with developmental delay 4. Patients with significant visual/hearing problems

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 84, 'type': 'ESTIMATED'}}

Updated at

2024-04-02

1 organization

1 product

1 indication

Organization

Aga Khan University

Product

Midazolam

Indication

Anxiety and Fear