S-ketamin Premedication in Pediatric EENT Surgery

Sponsor

Eye & ENT Hospital of Fudan University (Other)

Overall Status

Completed

CT.gov ID

NCT04757675

Collaborator

(none)

320

Enrollment

Location

Arms

10.1

Actual Duration (Months)

31.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Emotions Separation Anxiety Pain, Procedural	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	Early Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Sep 1, 2021

Actual Study Completion Date :

Jan 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

The modified Yale Preoperative Anxiety Scale [1 min after premedication]
A validated observational tool for assessing children's anxiety
The modified Yale Preoperative Anxiety Scale [5 min after premedication]
A validated observational tool for assessing children's anxiety
The modified Yale Preoperative Anxiety Scale [10 min after premedication]
A validated observational tool for assessing children's anxiety
The modified Yale Preoperative Anxiety Scale [20 min after premedication]
A validated observational tool for assessing children's anxiety
The modified Yale Preoperative Anxiety Scale [30 min after premedication]
A validated observational tool for assessing children's anxiety

Secondary Outcome Measures

Parental Separation Anxiety Scale (PSAS) [30 min after premedication]
= 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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye and ENT Hospital of Fudan University	Shanghai		China

Sponsors and Collaborators

Eye & ENT Hospital of Fudan University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hui Qiao, Clinical Anesthesiologist, Eye & ENT Hospital of Fudan University

ClinicalTrials.gov Identifier:

NCT04757675

Other Study ID Numbers:

Premedication s-ketamin

First Posted:

Feb 17, 2021

Last Update Posted:

Apr 27, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2022