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Clinical Trials/NCT06670846
NCT06670846
Recruiting
Not Applicable

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

Tunis University1 site in 1 country63 target enrollmentJanuary 2, 2024

Overview

Phase
Not Applicable
Intervention
Lollipop
Conditions
Anxiety, Preoperative
Sponsor
Tunis University
Enrollment
63
Locations
1
Primary Endpoint
anxiety
Status
Recruiting
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 2, 2024
End Date
December 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Tunis University
Responsible Party
Principal Investigator
Principal Investigator

Mehdi Trifa

Head of the anesthésia and intensive care department

Tunis University

Eligibility Criteria

Inclusion Criteria

  • Age \> 4 ans , ASA 1 ou 2

Exclusion Criteria

  • Children who rejected premedication - The occurrence of perioperative complications

Arms & Interventions

Lollipop arm

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

Intervention: Lollipop

Midazolam arm

Intranasal midazolam at 0.3 mg/kg 15 minutes before anesthesia

Intervention: distraction using intranasal Midazolam

Outcomes

Primary Outcomes

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

  • agitation(10 minutes after extubation)
  • parent separation(15 minutes after premedication)

Study Sites (1)

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