S-ketamin Premedication in Pediatric EENT Surgery

Emotions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04757675
• Other study ID #: Premedication s-ketamin
• Status: Completed
• Phase: Early Phase 1
• Start date: March 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: April 2022
• Source: Eye & ENT Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: January 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety, Separation
• Emotions
• Pain, Procedural
• Separation Anxiety

Intervention

Drug:
• S-ketamine 0.3
0.3 µg/kg intravenous injection s-ketamin
• S-ketamine 0.5
0.5 µg/kg intravenous injection s-ketamin
• S-ketamine 2
2 µg/kg intranasal s-ketamin
• S-ketamine 1+Dexmedetomidine 1
1 µg/kg intranasal s-ketamin + 1 µg/kg intranasal dexmedetomidine
• S-ketamine 0.5 +Dexmedetomidine 2
0.5 µg/kg intranasal s-ketamin + 2 µg/kg intranasal dexmedetomidine

Locations

Country	Name	City	State
China	Eye and ENT Hospital of Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The modified Yale Preoperative Anxiety Scale	A validated observational tool for assessing children's anxiety	1 min after premedication
Primary	The modified Yale Preoperative Anxiety Scale	A validated observational tool for assessing children's anxiety	5 min after premedication
Primary	The modified Yale Preoperative Anxiety Scale	A validated observational tool for assessing children's anxiety	10 min after premedication
Primary	The modified Yale Preoperative Anxiety Scale	A validated observational tool for assessing children's anxiety	20 min after premedication
Primary	The modified Yale Preoperative Anxiety Scale	A validated observational tool for assessing children's anxiety	30 min after premedication
Secondary	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	30 min after premedication
Secondary	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.	15 min after premedication