NCT04757675

S-ketamin Premedication in Pediatric EENT Surgery

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Emotions
• Separation Anxiety
• Pain, Procedural

Interventions

Type	Name	Description
DRUG	S-ketamine 0.3	0.3 μg/kg intravenous injection s-ketamin
DRUG	S-ketamine 0.5	0.5 μg/kg intravenous injection s-ketamin
DRUG	S-ketamine 2	2 μg/kg intranasal s-ketamin
DRUG	S-ketamine 1+Dexmedetomidine 1	1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine
DRUG	S-ketamine 0.5 +Dexmedetomidine 2	0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-09-01
• Completion: 2022-01-01
• First posted: 2021-02-17
• Last updated: 2022-04-27

Locations

1 site across 1 country: China