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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-01-15

Brief Summary

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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.

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Detailed Description

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Children will be randomized to receive, either midazolam (0.5mg/kg) or dexmedetomidine (1mcg/kg), as anesthetic premedication. Emergence agitation will be assessed by PAED scale.

Conditions

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Emergence Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Oral saline

Intervention Type DRUG

Oral saline, 0.25ml/kg

Midazolam oral solution

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

Group Type ACTIVE_COMPARATOR

Midazolam oral solution

Intervention Type DRUG

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

Nasal saline

Intervention Type DRUG

Nasal saline 0.01ml/kg

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Midazolam oral solution

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

Intervention Type DRUG

Oral saline

Oral saline, 0.25ml/kg

Intervention Type DRUG

Nasal saline

Nasal saline 0.01ml/kg

Intervention Type DRUG

Other Intervention Names

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Precedex 0.9% Saline solution 0.9% Saline solution

Eligibility Criteria

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Inclusion Criteria

* 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.