NCT04263844

Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention

Comparison of Efficacy of Premedication Between Dexmedetomidine and Midazolam Intranasal for the Prevention of Emergence Delirium in Children Undergoing Ophthalmic Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

Summary

This study is a double-blind clinical trial, in pediatric patients aged 1-12 years with physical status ASA (American Society of Anesthesiology) 1 and 2 who underwent eye surgery under general anesthesia using Sevoflurane inhalation agents, in investigator institution during February-May 2019.. There were 64 children obtained by consecutive sampling, who underwent eye surgery in investigator institution during February-May 2019. The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from Emergence Delirium (ED) events, recovery time, and post-premedication desaturation events. Data analysis using Chi Square test and Mann-Whitney test.

Detailed description

There were 64 children obtained by consecutive sampling, The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from ED events, recovery time, and post-premedication desaturation events.

Conditions

• Emergence Delirium

Interventions

Type	Name	Description
DRUG	Intranasal dexmedetomidine	subject will receive premedication with intranasal dexmedetomidine thirty minutes before induction
DRUG	Intranasal Midazolam	subject will receive premedication with intranasal midazolam thirty minutes before induction

Timeline

• Start date: 2019-01-10
• Primary completion: 2019-10-10
• Completion: 2019-10-10
• First posted: 2020-02-11
• Last updated: 2020-02-12

Locations

1 site across 1 country: Indonesia