Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06670846

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Anxiety, Preoperative Anxiety Disorders Mental Disorders

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bechir Hamza hospital

Tunis, Tunis Governorate, 2001, Tunisia

Location status: Recruiting

Location contact

Salma Aouadi, consultant

CONTACT

salma Aouadi, consultant

CONTACT

[email protected]

56652210

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 4 ans , ASA 1 ou 2

Exclusion criteria

  • Children who rejected premedication - The occurrence of perioperative complications

Treatment and study plan

Lollipop

Device

Distraction using a Lollipop 15 minutes before anesthesia

distraction using intranasal Midazolam

Drug

Distraction using intranasal Midazolam 15 minutes before anesthesia

Primary outcomes

  1. anxiety

    Time frame: immediatly before premedication and 15 minutes after premedication

    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.

Secondary outcomes

  1. agitation

    Time frame: 10 minutes after extubation

    Emergence agitation assessed using the Pediatric Anesthesia Emergence Delirium Scale (PAEDS), which has a minimum score of 0 and a maximum score of 20. A higher score indicates more severe agitation during emergence from anesthesia.

  2. parent separation

    Time frame: 15 minutes after premedication

    The quality of parent separation Defined by 3 items: the child waits near their parents rated as 1, clings to their parents rated as 2, or refuses separation rated as 3

Study contacts

Contact information is provided by the study sponsor or research team.

salma Aouadi, consultant

CONTACT

[email protected]

0021656652210

Sponsors and collaborators

Lead sponsor

Tunis University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.