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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.3 SK iv | Experimental | 0.3 μg/kg intravenous injection s-ketamin |
|
| 0.5 SK iv | Experimental | 0.5 μg/kg intravenous injection s-ketamin |
|
| 2 SK in | Experimental | 2 μg/kg intranasal s-ketamin |
|
| 1 SK in + 1 DEX in | Experimental | 1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine |
|
| 0.5 SK in + 2 DEX in | Experimental | 0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-ketamine 0.3 | Drug | 0.3 μg/kg intravenous injection s-ketamin |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Parental Separation Anxiety Scale (PSAS) |
| 30 min after premedication |
| Emotional State Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hui Qiao, M.D. | Eye and ENT Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye and ENT Hospital of Fudan University | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39263280 | Derived | Qiao H, Zhuang Y, Lv P, Ye Z, Lu Y, Jia J. Intranasal esketamine versus esketamine-dexmedetomidine combination for premedication in pediatric patients undergoing strabismus surgery: a randomized controlled trial. Transl Pediatr. 2024 Aug 31;13(8):1327-1335. doi: 10.21037/tp-24-45. Epub 2024 Aug 28. |
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| ID | Term |
|---|---|
| D001010 | Anxiety, Separation |
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D065886 | Neurodevelopmental Disorders |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
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| S-ketamine 0.5 | Drug | 0.5 μg/kg intravenous injection s-ketamin |
|
|
| S-ketamine 2 | Drug | 2 μg/kg intranasal s-ketamin |
|
|
| S-ketamine 1+Dexmedetomidine 1 | Drug | 1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine |
|
|
| S-ketamine 0.5 +Dexmedetomidine 2 | Drug | 0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine |
|
|
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 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |