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

ConditionAnxiety, Preoperative
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-10
SponsorTunis University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age > 4 ans , ASA 1 ou 2

Disqualifiers

Children who rejected premedication - The occurrence of perioperative complications

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lollipop

    Device

    Distraction using a Lollipop 15 minutes before anesthesia

  • distraction using intranasal Midazolam

    Drug

    Distraction using intranasal Midazolam 15 minutes before anesthesia

Treatment groups

63 Participants
are divided into 2 treatment groups
Group A: Lollipop armExperimental treatment 1 intervention
Group B: Midazolam armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

anxiety

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.

Time frame
immediatly before premedication and 15 minutes after premedication

Secondary outcomes

1

agitation

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.

Time frame
10 minutes after extubation
2

parent separation

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

Time frame
15 minutes after premedication

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tunis University

Lead sponsor

Source ClinicalTrials.gov
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