Anxiety, Preoperative
Conditions
Keywords
anxiety, children, anesthesia, distraction, midazolam
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).
Interventions
DEVICELollipop
Distraction using a Lollipop 15 minutes before anesthesia
DRUGdistraction using intranasal Midazolam
Distraction using intranasal Midazolam 15 minutes before anesthesia
Sponsors
Tunis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* Age \> 4 ans , ASA 1 ou 2
Exclusion criteria
* Children who rejected premedication - The occurrence of perioperative complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| anxiety | 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
| Measure | Time frame | Description |
|---|---|---|
| agitation | 10 minutes after extubation | 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. |
| parent separation | 15 minutes after premedication | 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 |
Countries
Tunisia
Contacts
Primary Contactsalma Aouadi, consultant
Outcome results
None listed