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

NCT03171740 | Completed Phase 3

• 1 other identifier: VictorSoutoAnestesiologia2017
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Emergence Delirium; Emergence Agitation; premedication; dexmedetomidine; midazolam

Outcome Measures

Primary Outcomes (1)

• Emergence agitation

  Anesthesiologist provider's reported score on PAED (Paediatric Anesthesia Emergence Scale) during the first 15 minutes after the extubation. The PAED consists of four items. Each item is scored 0-4 yielding a total between 0 and 20.

  15 minutes

Secondary Outcomes (5)

• Bradycardia

  2 hours

• Hypotension

  2 hours

• Intraocular pressure

  15-minutes

• Respiratory depression

  30 minutes

• Paradoxal agitation

  30 minutes

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Children will receive 1mcg/kg intranasal dexmedetomidine and oral saline, 30 minutes before going to operation theater.

Drug: Dexmedetomidine; Drug: Oral saline

Midazolam oral solution

ACTIVE COMPARATOR

Children will receive 0,5mg/kg oral midazolam and intranasal saline, 30 minutes before going to operation theater.

Drug: Midazolam oral solution; Drug: Nasal saline

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

Dexmedetomidine

Midazolam oral solution DRUG

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

Midazolam oral solution

Oral saline DRUG

Oral saline, 0.25ml/kg

Also known as: 0.9% Saline solution

Dexmedetomidine

Nasal saline DRUG

Nasal saline 0.01ml/kg

Also known as: 0.9% Saline solution

Midazolam oral solution

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Scheduled for amygdalectomy
• American Society of Anesthesiologists Physical Status PI or PII
• Absence of congenital neuropathy
• Absence of cardiac pathology (any)
• Intolerance to one of the studied drugs.

You may not qualify if:

• Protocol violation
• Need to transfer for ICU intubated

Sponsors & Collaborators

• Brasilia University Hospital: lead

Study Sites (1)

University Hospital of Brasilia University

Brasília, Federal District, 7000000, Brazil

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Midazolam; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Gabriel MN Guimarães, MD

  University of Brasilia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will not know which group they will be allocated. The anesthesia care provider will not know which premedication the patient received because another professional, who is not from the research team, will provide it to the child. The investigator and outcome assessor will only know the allocated group latter by a code which will be revealed after the end of the analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of anesthesiology

Model Details: All participants will receive an intranasal and an oral drug. One group will receive oral midazolam and intranasal saline, the other will receive oral saline and intranasal dexmededomedine.

Study Record Dates

• First Submitted: May 27, 2017
• First Posted: May 31, 2017
• Study Start: June 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: January 15, 2018
• Last Updated: July 13, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)