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

Emergence Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03171740
• Other study ID #: VictorSoutoAnestesiologia2017
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2017
• Est. completion date: January 15, 2018

Study information

• Verified date: July 2018
• Source: Brasilia University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 15, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Psychomotor Agitation

Intervention

Drug:
• Dexmedetomidine
Intranasal dexmedetomidine, 1mcg/kg (it is a 100mcg/ml solution)
• Midazolam oral solution
Oral midazolam, 0.5mg/kg (its a 2mg/ml solution)
• Oral saline
Oral saline, 0.25ml/kg
• Nasal saline
Nasal saline 0.01ml/kg

Locations

Country	Name	City	State
Brazil	University Hospital of Brasilia University	Brasilia	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Brasilia University Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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