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S-ketamin Premedication in Pediatric EENT Surgery

Primary Purpose

Emotions, Separation Anxiety, Pain, Procedural

Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
S-ketamine 0.3
S-ketamine 0.5
S-ketamine 2
S-ketamine 1+Dexmedetomidine 1
S-ketamine 0.5 +Dexmedetomidine 2
Sponsored by
Eye & ENT Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emotions

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Eye and ENT Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

0.3 SK iv

0.5 SK iv

2 SK in

1 SK in + 1 DEX in

0.5 SK in + 2 DEX in

Arm Description

0.3 μg/kg intravenous injection s-ketamin

0.5 μg/kg intravenous injection s-ketamin

2 μg/kg intranasal s-ketamin

1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine

0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine

Outcomes

Primary Outcome Measures

The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety
The modified Yale Preoperative Anxiety Scale
A validated observational tool for assessing children's anxiety

Secondary Outcome Measures

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
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.

Full Information

First Posted
February 13, 2021
Last Updated
April 20, 2022
Sponsor
Eye & ENT Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04757675
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eye & ENT Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotions, Separation Anxiety, Pain, Procedural

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.3 SK iv
Arm Type
Experimental
Arm Description
0.3 μg/kg intravenous injection s-ketamin
Arm Title
0.5 SK iv
Arm Type
Experimental
Arm Description
0.5 μg/kg intravenous injection s-ketamin
Arm Title
2 SK in
Arm Type
Experimental
Arm Description
2 μg/kg intranasal s-ketamin
Arm Title
1 SK in + 1 DEX in
Arm Type
Experimental
Arm Description
1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine
Arm Title
0.5 SK in + 2 DEX in
Arm Type
Experimental
Arm Description
0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
S-ketamine 0.3
Other Intervention Name(s)
Jiangsu Hengrui Medicine Co.,Ltd.
Intervention Description
0.3 μg/kg intravenous injection s-ketamin
Intervention Type
Drug
Intervention Name(s)
S-ketamine 0.5
Other Intervention Name(s)
Jiangsu Hengrui Medicine Co.,Ltd.
Intervention Description
0.5 μg/kg intravenous injection s-ketamin
Intervention Type
Drug
Intervention Name(s)
S-ketamine 2
Other Intervention Name(s)
Jiangsu Hengrui Medicine Co.,Ltd.
Intervention Description
2 μg/kg intranasal s-ketamin
Intervention Type
Drug
Intervention Name(s)
S-ketamine 1+Dexmedetomidine 1
Other Intervention Name(s)
Jiangsu Hengrui Medicine Co.,Ltd.
Intervention Description
1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
S-ketamine 0.5 +Dexmedetomidine 2
Other Intervention Name(s)
Jiangsu Hengrui Medicine Co.,Ltd.
Intervention Description
0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine
Primary Outcome Measure Information:
Title
The modified Yale Preoperative Anxiety Scale
Description
A validated observational tool for assessing children's anxiety
Time Frame
1 min after premedication
Title
The modified Yale Preoperative Anxiety Scale
Description
A validated observational tool for assessing children's anxiety
Time Frame
5 min after premedication
Title
The modified Yale Preoperative Anxiety Scale
Description
A validated observational tool for assessing children's anxiety
Time Frame
10 min after premedication
Title
The modified Yale Preoperative Anxiety Scale
Description
A validated observational tool for assessing children's anxiety
Time Frame
20 min after premedication
Title
The modified Yale Preoperative Anxiety Scale
Description
A validated observational tool for assessing children's anxiety
Time Frame
30 min after premedication
Secondary Outcome Measure Information:
Title
Parental Separation Anxiety Scale (PSAS)
Description
= 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
Time Frame
30 min after premedication
Title
Emotional State Scale
Description
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.
Time Frame
15 min after premedication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Qiao, M.D.
Organizational Affiliation
Eye and ENT Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye and ENT Hospital of Fudan University
City
Shanghai
Country
China

12. IPD Sharing Statement

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S-ketamin Premedication in Pediatric EENT Surgery

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