S-ketamin Premedication in Pediatric EENT Surgery

Early Phase 1

Completed

• Conditions: Pain, Procedural; Separation Anxiety; Emotions
• Interventions: 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

• Registration Number: NCT04757675
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2021-02-13
• Study First Submitted QC: 2021-02-13
• Study First Posted: 2021-02-17
• Study Start: 2021-03-01
• Primary Completion: 2021-09-01
• Study Completion: 2022-01-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.3 SK iv	S-ketamine 0.3	0.3 μg/kg intravenous injection s-ketamin
0.5 SK iv	S-ketamine 0.5	0.5 μg/kg intravenous injection s-ketamin
2 SK in	S-ketamine 2	2 μg/kg intranasal s-ketamin
1 SK in + 1 DEX in	S-ketamine 1+Dexmedetomidine 1	1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine
0.5 SK in + 2 DEX in	S-ketamine 0.5 +Dexmedetomidine 2	0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine

Primary Outcome Measures

Name	Time	Method
The modified Yale Preoperative Anxiety Scale	30 min after premedication	A validated observational tool for assessing children's anxiety

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Eye and ENT Hospital of Fudan University; 🇨🇳 Shanghai, China