Management of Preoperative Anxiety in Children: Could a Lollipop Be the Solution?

NCT06670846 | Recruiting

• 1 other identifier: 302023
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the effectiveness of distraction using a lollipop versus premedication with intranasal midazolam to manage preoperative anxiety in pediatric anesthesia.

Conditions

Anxiety, Preoperative

Keywords

anxiety; children; anesthesia; distraction; midazolam

Outcome Measures

Primary Outcomes (1)

• anxiety

  Anxiety was assessed using the modified Yale Preoperative Anxiety Scale (mYPAS) before and after premedication. The myPAS score includes 5 items, with a minimum value of 4 and a maximum value of 22; a higher score indicates a major anxiety.

  immediatly before premedication and 15 minutes after premedication

Secondary Outcomes (2)

• agitation

  10 minutes after extubation

• parent separation

  15 minutes after premedication

Study Arms (2)

Lollipop arm

EXPERIMENTAL

Distraction using a lollipop (group L) 15 minutes before entering the operating room

Device: Lollipop

Midazolam arm

ACTIVE COMPARATOR

Intranasal midazolam at 0.3 mg/kg 15 minutes before anesthesia

Drug: distraction using intranasal Midazolam

Interventions

Lollipop DEVICE

Distraction using a Lollipop 15 minutes before anesthesia

Lollipop arm

distraction using intranasal Midazolam DRUG

Distraction using intranasal Midazolam 15 minutes before anesthesia

Midazolam arm

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age \> 4 ans , ASA 1 ou 2

You may not qualify if:

• Children who rejected premedication - The occurrence of perioperative complications

Sponsors & Collaborators

• Tunis University: lead

Study Sites (1)

Bechir Hamza hospital

Tunis, Tunis Governorate, 2001, Tunisia

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

salma Aouadi, consultant

CONTACT

0021656652210; salmaaouadi1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the anesthésia and intensive care department

Model Details: Chidren were randomized into two groups to receive either intranasal midazolam at 0.3 mg/kg (group M) or distraction using a lollipop (group L) 15 minutes before entering the operating room

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 1, 2024
• Study Start: January 2, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

TU (1)