S-ketamin Premedication in Pediatric EENT Surgery

Study Overview
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Brief Summary
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We aim to investigate the effects of premedication (intranasal or intravenous administration) of s-ketamin, dexmedetomidine, and combination for premedication in children undergoing ENT surgery.

Detailed Description
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Three hundred children aged between 2 and 12 years were randomly allocated to one of five groups: 0.3 μg/kg intravenous injection s-ketamin; 0.5 μg/kg intravenous injection s-ketamin; 2 μg/kg intranasal s-ketamin group; 1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine group; 0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine group. The modified Yale Preoperative Anxiety Scale (m-YPAS) was used to assess preoperative anxiety at 1, 5, 10, 20, and 30min after premedication. A 4-point emotional state score was used to evaluate participators when they were separated from their parents and their response to intravenous cannulation or facemask application. Agitation scores (Pediatric Anesthesia Emergence Delirium [PAED] scale) and POV was assessed in the postanesthetic care unit (PACU). Times to endotracheal tube or laryngeal mask airway removal, discharge from the PACU, and patients' satisfaction degree were also assessed.

Official Title
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A Comparison of S-ketamin, Dexmedetomidine, and Combination as Premedication in Children Undergoing ENT Surgery

Conditions
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Emotions, Separation Anxiety, Pain, Procedural

Intervention / Treatment
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* Drug: S-ketamine 0.3
* Drug: S-ketamine 0.5
* Drug: S-ketamine 2
* Drug: S-ketamine 1+Dexmedetomidine 1
* Drug: S-ketamine 0.5 +Dexmedetomidine 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: After obtaining the informed consent from their parents or proxies, the children aged 2 to 12 years, scheduled for elective ENT surgery, of American Society of Anesthesiologists (ASA) I or II were enrolled in this study. Exclusion Criteria: Congenital heart diseases, congenital dysplasia, obstructive sleep apnea syndrome, upper respiratory tract infection, body mass index (BMI) ≥25, allergy to S-ketamin or dexmedetomidine, and severe liver or kidney disease.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.3 SK iv<br>0.3 μg/kg intravenous injection s-ketamin | Drug: S-ketamine 0.3<br>* 0.3 μg/kg intravenous injection s-ketamin<br>* Other names: Jiangsu Hengrui Medicine Co.,Ltd.;|
| Experimental: 0.5 SK iv<br>0.5 μg/kg intravenous injection s-ketamin | Drug: S-ketamine 0.5<br>* 0.5 μg/kg intravenous injection s-ketamin<br>* Other names: Jiangsu Hengrui Medicine Co.,Ltd.;|
| Experimental: 2 SK in<br>2 μg/kg intranasal s-ketamin | Drug: S-ketamine 2<br>* 2 μg/kg intranasal s-ketamin<br>* Other names: Jiangsu Hengrui Medicine Co.,Ltd.;|
| Experimental: 1 SK in + 1 DEX in<br>1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine | Drug: S-ketamine 1+Dexmedetomidine 1<br>* 1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine<br>* Other names: Jiangsu Hengrui Medicine Co.,Ltd.;|
| Experimental: 0.5 SK in + 2 DEX in<br>0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine | Drug: S-ketamine 0.5 +Dexmedetomidine 2<br>* 0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine<br>* Other names: Jiangsu Hengrui Medicine Co.,Ltd.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The modified Yale Preoperative Anxiety Scale | A validated observational tool for assessing children's anxiety | 1 min after premedication | 
| The modified Yale Preoperative Anxiety Scale | A validated observational tool for assessing children's anxiety | 5 min after premedication | 
| The modified Yale Preoperative Anxiety Scale | A validated observational tool for assessing children's anxiety | 10 min after premedication | 
| The modified Yale Preoperative Anxiety Scale | A validated observational tool for assessing children's anxiety | 20 min after premedication | 
| The modified Yale Preoperative Anxiety Scale | A validated observational tool for assessing children's anxiety | 30 min after premedication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental Separation Anxiety Scale (PSAS) | = easy separation = whimpers, but is easily reassured, not clinging = cries and cannot be easily reassured, but not clinging to parents = crying and clinging to parents | 30 min after premedication | 
| Emotional State Scale | Successful venous cannulation was defined as an ESS-4 ≤2 at the time of attempted cannulation, regardless of whether the vein was actually cannulated on the first attempt. | 15 min after premedication |