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

Brasilia University Hospital

Status and phase: Completed; Phase 3

Conditions: Emergence Delirium

Treatments: Drug: Dexmedetomidine; Drug: Midazolam oral solution; Drug: Nasal saline; Drug: Oral saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03171740

VictorSoutoAnestesiologia2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups

Dexmedetomidine

Active Comparator group

Description:

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

Treatment:

Drug: Oral saline

Drug: Dexmedetomidine

Midazolam oral solution

Active Comparator group

Description:

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

Treatment:

Drug: Midazolam oral solution

Drug: Nasal saline