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

Not Applicable

Recruiting

• Conditions: Anxiety, Preoperative
• Interventions: Device: Lollipop; Drug: distraction using intranasal Midazolam

• Registration Number: NCT06670846
• Lead Sponsor: Tunis University

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.

Detailed Description

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).

Study Timeline

• Study Start: 2024-01-02
• Status Verified: 2024-10
• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-31
• Last Update Submitted: 2024-10-31
• Study First Posted: 2024-11-01
• Last Update Posted: 2024-11-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Age > 4 ans , ASA 1 ou 2

Exclusion Criteria

• Children who rejected premedication - The occurrence of perioperative complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lollipop arm	Lollipop	Distraction using a lollipop (group L) 15 minutes before entering the operating room
Midazolam arm	distraction using intranasal Midazolam	Intranasal midazolam at 0.3 mg/kg 15 minutes before anesthesia

Primary Outcome Measures

Name	Time	Method
anxiety	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 Outcome Measures

Name	Time	Method
agitation	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.
parent separation	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

Trial Locations

Locations (1)

Bechir Hamza hospital; 🇹🇳 Tunis, Tunisia