Clinical trial NCT04757675: S-ketamin Premedication in Pediatric EENT Surgery
Official title: A Comparison of S-ketamin, Dexmedetomidine, and Combination as Premedication in Children Undergoing ENT Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Emotions
Separation Anxiety
Pain, Procedural
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 320
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The modified Yale Preoperative Anxiety Scale
timeFrame: 1 min after premedication
measure: The modified Yale Preoperative Anxiety Scale
timeFrame: 5 min after premedication
measure: The modified Yale Preoperative Anxiety Scale
timeFrame: 10 min after premedication
measure: The modified Yale Preoperative Anxiety Scale
timeFrame: 20 min after premedication
measure: The modified Yale Preoperative Anxiety Scale
timeFrame: 30 min after premedication
Secondary outcomes:
measure: Parental Separation Anxiety Scale (PSAS)
timeFrame: 30 min after premedication
measure: Emotional State Scale
timeFrame: 15 min after premedication
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye and ENT Hospital of Fudan University
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Hui Qiao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: