NCT05469412

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Anxiety and Fear

Interventions

Type	Name	Description
DEVICE	iPad®	Use of Technology.
DRUG	Midazolam	Standard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg).

Timeline

• Start date: 2023-03-20
• Primary completion: 2024-03-25
• Completion: 2024-04-01
• First posted: 2022-07-21
• Last updated: 2024-06-26

Locations

1 site across 1 country: Pakistan