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

Tunis University

Status: Enrolling

Conditions: Anxiety, Preoperative

Treatments: Drug: distraction using intranasal Midazolam; Device: Lollipop

Study type: Interventional

Funder types: Other

Identifiers

NCT06670846

302023

Details and patient eligibility

About

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.

Full 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).

Enrollment: 63 estimated patients

Sex: All

Ages: 4 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age > 4 ans , ASA 1 ou 2

Exclusion criteria

• Children who rejected premedication - The occurrence of perioperative complications

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Lollipop arm

Experimental group

Description:

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

Treatment:

Device: Lollipop

Midazolam arm

Active Comparator group

Description:

Intranasal midazolam at 0.3 mg/kg 15 minutes before anesthesia

Treatment:

Drug: distraction using intranasal Midazolam