Status:

COMPLETED

S-ketamin Premedication in Pediatric EENT Surgery

Lead Sponsor:

Eye & ENT Hospital of Fudan University

Conditions:

Emotions

Separation Anxiety

Eligibility:

All Genders

2-12 years

Phase:

EARLY_PHASE1

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 intranas...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

March 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2022

Estimated Enrollment :

320 Patients enrolled

Trial Details

Trial ID

NCT04757675

Start Date

March 1 2021

End Date

January 1 2022

Last Update

April 27 2022

Active Locations (1)

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1

Eye and ENT Hospital of Fudan University

Shanghai, China