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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04263844

Enrollment

Registered

2020-02-11

Start date

2019-01-10

Completion date

2019-10-10

Last updated

2020-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium

Keywords

emergence, delirium, dexmedetomidine, midazolam, pediatric

Brief 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.

Interventions

DRUGIntranasal dexmedetomidine

subject will receive premedication with intranasal dexmedetomidine thirty minutes before induction

DRUGIntranasal Midazolam

subject will receive premedication with intranasal midazolam thirty minutes before induction

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Years to 12 Years

Healthy volunteers

Inclusion criteria

* children undergoing ophthalmologic surgery with general anesthesia * children aged 1 - 12 years old * physical status ASA 1-2 * signing informed consent

Exclusion criteria

* children undergoing emergency surgery * children with PICU nursing after surgery * children with psychological and neurological condition * children with allergic history to dexmedetomidine and midazolam * children with history of malignant hyperthermia or family history of malignant hyperthermia * children with possibility of difficult intubation and ventilation

Design outcomes

Primary

Measure	Time frame	Description
incidence of emergence delirium thirty minutes after surgery	30 minutes	PAED score was measured

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026