Actively Recruiting

Phase Not Applicable
Age: 4Years - 10Years
All Genders
Healthy Volunteers
ID06670846

Management of Preoperative Anxiety in Children Using a Lollipop Versus Intranasal Midazolam

Led by Tunis University · Updated on 2024-11-01

63

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate how well a lollipop works compared to intranasal midazolam in managing anxiety before surgery in children aged 4 to 10 years. The study focuses on preoperative anxiety in pediatric anesthesia and compares two approaches to reduce stress in young patients. It is an interventional trial with random assignment to different treatment groups. Participants are randomly placed in one of two groups: one receives intranasal midazolam at a dose of 0.3 mg/kg, and the other is given a lollipop for distraction. Both treatments are given 15 minutes before entering the operating room. The anesthesia procedure is standardized, including intravenous induction with propofol and fentanyl, airway management with an age-appropriate IGEL mask, and maintenance with sevoflurane. Children's anxiety levels are measured before and 15 minutes after treatment using the modified Yale Preoperative Anxiety Scale. Researchers also assess sedation upon entering the operating room, how well children separate from their parents, how they accept the facemask during induction, and post-surgery agitation using the Pediatric Anesthesia Emergence Delirium Scale. The total participation spans the preoperative period and early recovery, with monitoring before, during, and shortly after anesthesia.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 4Years - 10Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 4 years
  • ASA physical status 1 or 2
Not Eligible

You will not qualify if you...

  • Children who rejected premedication
  • Occurrence of perioperative complications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day on the day of surgery

Participants receive either intranasal midazolam or distraction using a lollipop 15 minutes before anesthesia to manage preoperative anxiety.

1 visit (in-person)

Post-operative Follow-up

Duration - Approximately 10 minutes after extubation

Participants are monitored for agitation and recovery after anesthesia.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Bechir Hamza hospital

Tunis, Tunis Governorate, Tunisia, 2001

Actively Recruiting

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Research Team

S

salma Aouadi, consultant

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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