Eye and ENT Hospital of Fudan University
Shanghai, China
NCT Number: NCT04757675
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.
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Notify Me2 year–12 year
All sexes
Interventional
Early Phase 1
Shanghai, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.3 μg/kg intravenous injection s-ketamin
Other names: Jiangsu Hengrui Medicine Co.,Ltd.
0.5 μg/kg intravenous injection s-ketamin
Other names: Jiangsu Hengrui Medicine Co.,Ltd.
2 μg/kg intranasal s-ketamin
Other names: Jiangsu Hengrui Medicine Co.,Ltd.
1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine
Other names: Jiangsu Hengrui Medicine Co.,Ltd.
0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine
Other names: Jiangsu Hengrui Medicine Co.,Ltd.
Time frame: 1 min after premedication
A validated observational tool for assessing children's anxiety
Time frame: 5 min after premedication
A validated observational tool for assessing children's anxiety
Time frame: 10 min after premedication
A validated observational tool for assessing children's anxiety
Time frame: 20 min after premedication
A validated observational tool for assessing children's anxiety
Time frame: 30 min after premedication
A validated observational tool for assessing children's anxiety
Time frame: 30 min after premedication
Time frame: 15 min after premedication
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.
Eye & ENT Hospital of Fudan University
Other
A Comparison of S-ketamin, Dexmedetomidine, and Combination as Premedication in Children Undergoing ENT Surgery
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