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

Phase 3

Completed

• Conditions: Emergence Delirium
• Interventions: Drug: Dexmedetomidine; Drug: Midazolam oral solution; Drug: Oral saline; Drug: Nasal saline

• Registration Number: NCT03171740
• Lead Sponsor: Brasilia University Hospital

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-27
• Study First Submitted QC: 2017-05-30
• Study First Posted: 2017-05-31
• Study Start: 2017-06-01
• Primary Completion: 2017-12-01
• Study Completion: 2018-01-15
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-12
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

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Exclusion Criteria

• Protocol violation
• Need to transfer for ICU intubated

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	Children will receive 1mcg/kg intranasal dexmedetomidine and oral saline, 30 minutes before going to operation theater.
Dexmedetomidine	Oral saline	Children will receive 1mcg/kg intranasal dexmedetomidine and oral saline, 30 minutes before going to operation theater.
Midazolam oral solution	Midazolam oral solution	Children will receive 0,5mg/kg oral midazolam and intranasal saline, 30 minutes before going to operation theater.
Midazolam oral solution	Nasal saline	Children will receive 0,5mg/kg oral midazolam and intranasal saline, 30 minutes before going to operation theater.

Primary Outcome Measures

Name	Time	Method
Emergence agitation	15 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Bradycardia	2 hours	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.
Hypotension	2 hours	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.
Intraocular pressure	15-minutes	It will be measured in the first 15 minutes after the induction of general anesthesia using an ocular tonometer. It is measured in mmHg.
Respiratory depression	30 minutes	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).
Paradoxal agitation	30 minutes	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).

Trial Locations

Locations (1)

University Hospital of Brasilia University; 🇧🇷 Brasilia, Distrito Federal, Brazil