NCT06670846

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Tunis University · Academic / Other
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Accepted

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).

Conditions

• Anxiety, Preoperative

Interventions

Type	Name	Description
DEVICE	Lollipop	Distraction using a Lollipop 15 minutes before anesthesia
DRUG	distraction using intranasal Midazolam	Distraction using intranasal Midazolam 15 minutes before anesthesia

Timeline

• Start date: 2024-01-02
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-11-01
• Last updated: 2024-11-01

Locations

1 site across 1 country: Tunisia