Comparison of Pharmacological and Non-Pharmacological Interventions For Alleviating Preoperative Anxiety In Children

Aga Khan University

Status: Completed

Conditions: Anxiety and Fear

Treatments: Device: iPad®; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT05469412

2022-7684-21894

Details and patient eligibility

About

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

Full description

Preparation for surgery with the induction of general anesthesia can be a stressful experience for a child. Preoperative anxiety can prolong induction of anesthesia and postoperative recovery, as well as increasing the risk of postoperative delirium, pain, and analgesic use.

Pharmacological interventions are associated with increased cost to the hospital, potential surgical delay while waiting for the medication to take effect, and delayed discharge from the recovery room. Non-pharmacological modalities comprise education, behavioral techniques, parental presence at induction of anesthesia, and using technology including cellular phones and tablets/iPad, with each category including an array of effective strategies for reducing anxiety.

Enrollment: 84 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Interventional group

Experimental group

Description:

Standard management combined with distraction by using technology (Tablets/iPads).

Treatment:

Device: iPad®

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Midazolam