NCT04757675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Mar 2021

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

February 13, 2021

Last Update Submit

April 20, 2022

Conditions

EmotionsSeparation AnxietyPain, Procedural

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

  • Parental Separation Anxiety Scale (PSAS)

    30 min after premedication

  • Emotional State Scale

    15 min after premedication

Study Arms (5)

0.3 SK iv

EXPERIMENTAL

0.3 μg/kg intravenous injection s-ketamin

Drug: S-ketamine 0.3

0.5 SK iv

EXPERIMENTAL

0.5 μg/kg intravenous injection s-ketamin

Drug: S-ketamine 0.5

2 SK in

EXPERIMENTAL

2 μg/kg intranasal s-ketamin

Drug: S-ketamine 2

1 SK in + 1 DEX in

EXPERIMENTAL

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

Drug: S-ketamine 1+Dexmedetomidine 1

0.5 SK in + 2 DEX in

EXPERIMENTAL

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

Drug: S-ketamine 0.5 +Dexmedetomidine 2

Interventions

S-ketamine 0.3DRUG

0.3 μg/kg intravenous injection s-ketamin

Also known as: Jiangsu Hengrui Medicine Co.,Ltd.
0.3 SK iv
S-ketamine 0.5DRUG

0.5 μg/kg intravenous injection s-ketamin

Also known as: Jiangsu Hengrui Medicine Co.,Ltd.
0.5 SK iv
S-ketamine 2DRUG

2 μg/kg intranasal s-ketamin

Also known as: Jiangsu Hengrui Medicine Co.,Ltd.
2 SK in
S-ketamine 1+Dexmedetomidine 1DRUG

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

Also known as: Jiangsu Hengrui Medicine Co.,Ltd.
1 SK in + 1 DEX in
S-ketamine 0.5 +Dexmedetomidine 2DRUG

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

Also known as: Jiangsu Hengrui Medicine Co.,Ltd.
0.5 SK in + 2 DEX in

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye and ENT Hospital of Fudan University

Shanghai, China

Location

Related Publications (1)

  • Qiao H, Zhuang Y, Lv P, Ye Z, Lu Y, Jia J. Intranasal esketamine versus esketamine-dexmedetomidine combination for premedication in pediatric patients undergoing strabismus surgery: a randomized controlled trial. Transl Pediatr. 2024 Aug 31;13(8):1327-1335. doi: 10.21037/tp-24-45. Epub 2024 Aug 28.

    PMID: 39263280DERIVED

MeSH Terms

Conditions

Anxiety, SeparationPain, Procedural

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersNeurodevelopmental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hui Qiao, M.D.

    Eye and ENT Hospital of Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Anesthesiologist

Study Record Dates

First Submitted

February 13, 2021

First Posted

February 17, 2021

Study Start

March 1, 2021

Primary Completion

September 1, 2021

Study Completion

January 1, 2022

Last Updated

April 27, 2022

Record last verified: 2022-04

Locations

CN(1)