Emotions, Pain, Procedural, Separation Anxiety
Conditions
Brief summary
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
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.
Interventions
DRUGS-ketamine 0.3
0.3 μg/kg intravenous injection s-ketamin
DRUGS-ketamine 0.5
0.5 μg/kg intravenous injection s-ketamin
DRUGS-ketamine 2
2 μg/kg intranasal s-ketamin
DRUGS-ketamine 1+Dexmedetomidine 1
1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine
DRUGS-ketamine 0.5 +Dexmedetomidine 2
0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine
Sponsors
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The modified Yale Preoperative Anxiety Scale | 1 min after premedication | A validated observational tool for assessing children's anxiety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental Separation Anxiety Scale (PSAS) | 30 min after premedication | 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 |
| Emotional State Scale | 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. |
Countries
China
Outcome results
None listed