S-ketamin Premedication in Pediatric EENT Surgery

A Comparison of S-ketamin, Dexmedetomidine, and Combination as Premedication in Children Undergoing ENT Surgery

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.

Study Overview

• Status: Completed
• Conditions: Pain, Procedural; Emotions; Separation Anxiety
• Intervention / Treatment: Drug: S-ketamine 0.3; Drug: S-ketamine 0.5; Drug: S-ketamine 2; Drug: S-ketamine 1+Dexmedetomidine 1; Drug: S-ketamine 0.5 +Dexmedetomidine 2

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.

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Eye and ENT Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.3 SK iv; 0.3 μg/kg intravenous injection s-ketamin	Drug: S-ketamine 0.3; 0.3 μg/kg intravenous injection s-ketamin; Other Names: Jiangsu Hengrui Medicine Co.,Ltd.
Experimental: 0.5 SK iv; 0.5 μg/kg intravenous injection s-ketamin	Drug: S-ketamine 0.5; 0.5 μg/kg intravenous injection s-ketamin; Other Names: Jiangsu Hengrui Medicine Co.,Ltd.
Experimental: 2 SK in; 2 μg/kg intranasal s-ketamin	Drug: S-ketamine 2; 2 μg/kg intranasal s-ketamin; Other Names: Jiangsu Hengrui Medicine Co.,Ltd.
Experimental: 1 SK in + 1 DEX in; 1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine	Drug: S-ketamine 1+Dexmedetomidine 1; 1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine; Other Names: Jiangsu Hengrui Medicine Co.,Ltd.
Experimental: 0.5 SK in + 2 DEX in; 0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine	Drug: S-ketamine 0.5 +Dexmedetomidine 2; 0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine; Other Names: Jiangsu Hengrui Medicine Co.,Ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Separation Anxiety Scale (PSAS)	= easy separation; = whimpers, but is easily reassured, not clinging; = cries and cannot be easily reassured, but not clinging to parents; = crying and clinging to parents	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.	15 min after premedication

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University
• Investigators: Principal Investigator: Hui Qiao, M.D., Eye and ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: February 13, 2021
• First Submitted That Met QC Criteria: February 13, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Anxiety Disorders; Neurodevelopmental Disorders; Pain, Procedural; Anxiety, Separation; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Psychotropic Drugs; Antidepressive Agents; Hypnotics and Sedatives; Ketamine; Dexmedetomidine; Esketamine
• Other Study ID Numbers: Premedication s-ketamin

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No