Skip to main content
OpenTrials
Completed

NCT Number: NCT04757675

S-ketamin Premedication in Pediatric EENT Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Eye and ENT Hospital of Fudan University

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

S-ketamine 0.3

Drug

0.3 μg/kg intravenous injection s-ketamin

Other names: Jiangsu Hengrui Medicine Co.,Ltd.

S-ketamine 0.5

Drug

0.5 μg/kg intravenous injection s-ketamin

Other names: Jiangsu Hengrui Medicine Co.,Ltd.

S-ketamine 2

Drug

2 μg/kg intranasal s-ketamin

Other names: Jiangsu Hengrui Medicine Co.,Ltd.

S-ketamine 1+Dexmedetomidine 1

Drug

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

Other names: Jiangsu Hengrui Medicine Co.,Ltd.

S-ketamine 0.5 +Dexmedetomidine 2

Drug

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

Other names: Jiangsu Hengrui Medicine Co.,Ltd.

Primary outcomes

  1. The modified Yale Preoperative Anxiety Scale

    Time frame: 1 min after premedication

    A validated observational tool for assessing children's anxiety

  2. The modified Yale Preoperative Anxiety Scale

    Time frame: 5 min after premedication

    A validated observational tool for assessing children's anxiety

  3. The modified Yale Preoperative Anxiety Scale

    Time frame: 10 min after premedication

    A validated observational tool for assessing children's anxiety

  4. The modified Yale Preoperative Anxiety Scale

    Time frame: 20 min after premedication

    A validated observational tool for assessing children's anxiety

  5. The modified Yale Preoperative Anxiety Scale

    Time frame: 30 min after premedication

    A validated observational tool for assessing children's anxiety

Secondary outcomes

  1. Parental Separation Anxiety Scale (PSAS)

    Time frame: 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
  2. Emotional State Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 17, 2021
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.