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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lollipop arm | Experimental | Distraction using a lollipop (group L) 15 minutes before entering the operating room |
|
| Midazolam arm | Active Comparator | Intranasal midazolam at 0.3 mg/kg 15 minutes before anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lollipop | Device | Distraction using a Lollipop 15 minutes before anesthesia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | immediatly before premedication and 15 minutes after premedication |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 minutes after extubation |
| parent separation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| salma Aouadi, consultant | Contact | 0021656652210 | salmaaouadi1@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bechir Hamza hospital | Recruiting | Tunis | Tunis Governorate | 2001 | Tunisia |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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Chidren 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
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| distraction using intranasal Midazolam |
| Drug |
Distraction using intranasal Midazolam 15 minutes before anesthesia |
|
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 |
| 15 minutes after premedication |