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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
320
0.3 μg/kg intravenous injection s-ketamin
0.5 μg/kg intravenous injection s-ketamin
2 μg/kg intranasal s-ketamin
Eye and ENT Hospital of Fudan University
Shanghai, China
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
Time frame: 1 min after premedication
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
Time frame: 5 min after premedication
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
Time frame: 10 min after premedication
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
Time frame: 20 min after premedication
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
Time frame: 30 min after premedication
Parental Separation Anxiety Scale (PSAS)
1. = easy separation 2. = whimpers, but is easily reassured, not clinging 3. = cries and cannot be easily reassured, but not clinging to parents 4. = crying and clinging to parents
Time frame: 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.
Time frame: 15 min after premedication
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1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine
0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine