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

Brasilia University Hospital22 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Emergence Delirium

Interventions

DexmedetomidineDRUG

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

Midazolam oral solutionDRUG

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

Oral salineDRUG

Oral saline, 0.25ml/kg

Eligibility

Sex: ALLMin age: 2 YearsMax age: 10 Years

Medical Language ↔ Plain English

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. Exclusion Criteria: * Protocol violation * Need to transfer for ICU intubated

Locations (1)

University Hospital of Brasilia University

Brasília, Federal District, Brazil

Outcomes

Primary Outcomes

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.

Time frame: 15 minutes

Secondary Outcomes

Bradycardia

It is defined as a heart rate lower than the expected for the age or a drop higher than 30% of the patient's lowest previous heart rate registered. It will be measured using pletysmography and ECG beat-by-beat during the surgery and it will be true if it occurs at least once.

Time frame: 2 hours

Hypotension

It is defined as a mean arterial pressure lower than the expected for the age or a drop higher than 30% of the patient's lowest previous mean arterial pressure registered. It will be measured using oscillatory method every 5 minutes during the surgery and it will be true if it occurs at least once.

Time frame: 2 hours

Intraocular pressure

It will be measured in the first 15 minutes after the induction of general anesthesia using an ocular tonometer. It is measured in mmHg.

Time frame: 15-minutes

Respiratory depression

Anesthesiologist provider's reported incidence respiratory depression in the child, before induction of general anesthesia. It will be true if the respiratory rate is slow for the age and the variable is dichotomic (true or false).

Time frame: 30 minutes

Paradoxal agitation

Anesthesiologist provider's reported incidence paradoxal agitation in the child, before induction of general anesthesia. The assessment subjective and the variable is dichotomic (true or false).

Data from ClinicalTrials.gov

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