Actively Recruiting
Management of Preoperative Anxiety in Children Using a Lollipop Versus Intranasal Midazolam
Led by Tunis University · Updated on 2024-11-01
63
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how well a lollipop works compared to intranasal midazolam in managing anxiety before surgery in children aged 4 to 10 years. The study focuses on preoperative anxiety in pediatric anesthesia and compares two approaches to reduce stress in young patients. It is an interventional trial with random assignment to different treatment groups. Participants are randomly placed in one of two groups: one receives intranasal midazolam at a dose of 0.3 mg/kg, and the other is given a lollipop for distraction. Both treatments are given 15 minutes before entering the operating room. The anesthesia procedure is standardized, including intravenous induction with propofol and fentanyl, airway management with an age-appropriate IGEL mask, and maintenance with sevoflurane. Children's anxiety levels are measured before and 15 minutes after treatment using the modified Yale Preoperative Anxiety Scale. Researchers also assess sedation upon entering the operating room, how well children separate from their parents, how they accept the facemask during induction, and post-surgery agitation using the Pediatric Anesthesia Emergence Delirium Scale. The total participation spans the preoperative period and early recovery, with monitoring before, during, and shortly after anesthesia.
CONDITIONS
Brief Title
Management of Preoperative Anxiety in Children: Could a Lollipop Be the Solution?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 4 years
- ASA physical status 1 or 2
You will not qualify if you...
- Children who rejected premedication
- Occurrence of perioperative complications
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day on the day of surgery
Participants receive either intranasal midazolam or distraction using a lollipop 15 minutes before anesthesia to manage preoperative anxiety.
1 visit (in-person)
Duration - Approximately 10 minutes after extubation
Participants are monitored for agitation and recovery after anesthesia.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Bechir Hamza hospital
Tunis, Tunis Governorate, Tunisia, 2001
Actively Recruiting
Research Team
S
salma Aouadi, consultant
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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