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Premedication With Intranasal Dexmedetomidine or Midazolam for Prevention of Emergence Agitation in Children

NCT03171740 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-07-13

No results posted yet for this study

Summary

Study where children will receive one premedication, either intranasal dexmedetomidine or oral midazolam, to reduce agitation on emergence of anesthesia. The hypothesis is that dexmedetomidine is superior but previous studies lack quality.

Conditions

  • Emergence Delirium

Interventions

DRUG

Dexmedetomidine

Intranasal dexmedetomidine, 1mcg/kg (it is a 100mcg/ml solution)

DRUG

Midazolam oral solution

Oral midazolam, 0.5mg/kg (its a 2mg/ml solution)

DRUG

Oral saline

Oral saline, 0.25ml/kg

DRUG

Nasal saline

Nasal saline 0.01ml/kg

Sponsors & Collaborators

  • Brasilia University Hospital

    lead OTHER

Principal Investigators

  • Gabriel MN Guimarães, MD · University of Brasilia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2017-12-01
Completion
2018-01-15

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03171740 on ClinicalTrials.gov