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

Study Overview
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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.

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.

Official Title
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Premedication With Intranasal Dexmedetomidine or Midazolam for Prevention of Emergence Agitation in Children: Superiority Randomized Clinical Trial

Conditions
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Emergence Delirium

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Midazolam oral solution
* Drug: Oral saline
* Drug: Nasal saline


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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>Children will receive 1mcg/kg intranasal dexmedetomidine and oral saline, 30 minutes before going to operation theater. | Drug: Dexmedetomidine<br>* Intranasal dexmedetomidine, 1mcg/kg (it is a 100mcg/ml solution)<br>* Other names: Precedex;Drug: Oral saline<br>* Oral saline, 0.25ml/kg<br>* Other names: 0.9% Saline solution;|
| Active Comparator: Midazolam oral solution<br>Children will receive 0,5mg/kg oral midazolam and intranasal saline, 30 minutes before going to operation theater. | Drug: Midazolam oral solution<br>* Oral midazolam, 0.5mg/kg (its a 2mg/ml solution)<br>Drug: Nasal saline<br>* Nasal saline 0.01ml/kg<br>* Other names: 0.9% Saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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). | 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). | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergence Delirium, Emergence Agitation, premedication, dexmedetomidine, midazolam