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

NCT ID: NCT06670846

Last Updated: 2024-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-02

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Participants 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. The anesthetic technique was standardized: a peripheral intravenous line, intravenous induction (propofol and fentanyl), airway management with an age-appropriate IGEL mask, and maintenance with sevoflurane. Anxiety was assessed using the modified Yale Preoperative Anxiety Scale (mYPAS) before and after premedication. The investigators also evaluate the level of sedation upon entering the operating room, the quality of parent separation, acceptance of the facemask during induction, and emergence of agitation using the Pediatric Anesthesia Emergence Delirium Scale (PAEDS).

Conditions

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Anxiety, Preoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Lollipop arm

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

Group Type EXPERIMENTAL

Lollipop

Intervention Type DEVICE

Distraction using a Lollipop 15 minutes before anesthesia

Midazolam arm

Intranasal midazolam at 0.3 mg/kg 15 minutes before anesthesia

Group Type ACTIVE_COMPARATOR

distraction using intranasal Midazolam

Intervention Type DRUG

Distraction using intranasal Midazolam 15 minutes before anesthesia

Interventions

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Lollipop

Distraction using a Lollipop 15 minutes before anesthesia

Intervention Type DEVICE

distraction using intranasal Midazolam

Distraction using intranasal Midazolam 15 minutes before anesthesia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age \> 4 ans , ASA 1 ou 2

Exclusion Criteria

* Children who rejected premedication - The occurrence of perioperative complications
Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tunis University

OTHER

Sponsor Role lead

Responsible Party

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Mehdi Trifa

Head of the anesthésia and intensive care department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bechir Hamza hospital

Tunis, Tunis Governorate, Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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salma Aouadi, consultant

Role: CONTACT

0021656652210

Facility Contacts

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salma Aouadi, consultant

Role: primary

Salma Aouadi, consultant

Role: backup

Other Identifiers

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302023

Identifier Type: -

Identifier Source: org_study_id

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