Management of Preoperative Anxiety in Children: Could a Lollipop Be the Solution?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lollipop, distraction using intranasal Midazolam.
- Who it may be relevant to
- Registry conditions: Anxiety, Preoperative. Basic parameters: 4 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Tunisia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Device Lollipop
Distraction using a Lollipop 15 minutes before anesthesia - Drug distraction using intranasal Midazolam
Distraction using intranasal Midazolam 15 minutes before anesthesia
Primary outcome measures
- anxiety [Time frame: immediatly before premedication and 15 minutes after premedication]
Secondary outcome measures (2)
- agitation [Time frame: 10 minutes after extubation]
- parent separation [Time frame: 15 minutes after premedication]
Eligibility criteria
Inclusion criteria
- Age > 4 ans , ASA 1 ou 2
Exclusion criteria
- Children who rejected premedication - The occurrence of perioperative complications
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Tunisia · 1 center
- Bechir Hamza hospital — Tunis
Identifiers
NCT: NCT06670846 · 302023