search
Back to results

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

Primary Purpose

Emergence Delirium

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Dexmedetomidine
Midazolam oral solution
Oral saline
Nasal saline
Sponsored by
Brasilia University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Delirium focused on measuring Emergence Delirium, Emergence Agitation, premedication, dexmedetomidine, midazolam

Eligibility Criteria

2 Years - 10 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • University Hospital of Brasilia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dexmedetomidine

Midazolam oral solution

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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).
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).

Full Information

First Posted
May 27, 2017
Last Updated
July 12, 2018
Sponsor
Brasilia University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03171740
Brief Title
Premedication With Intranasal Dexmedetomidine or Midazolam for Prevention of Emergence Agitation in Children
Official Title
Premedication With Intranasal Dexmedetomidine or Midazolam for Prevention of Emergence Agitation in Children: Superiority Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
January 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brasilia University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Delirium
Keywords
Emergence Delirium, Emergence Agitation, premedication, dexmedetomidine, midazolam

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participants will not know which group they will be allocated. The anesthesia care provider will not know which premedication the patient received because another professional, who is not from the research team, will provide it to the child. The investigator and outcome assessor will only know the allocated group latter by a code which will be revealed after the end of the analysis.
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
Children will receive 1mcg/kg intranasal dexmedetomidine and oral saline, 30 minutes before going to operation theater.
Arm Title
Midazolam oral solution
Arm Type
Active Comparator
Arm Description
Children will receive 0,5mg/kg oral midazolam and intranasal saline, 30 minutes before going to operation theater.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Intranasal dexmedetomidine, 1mcg/kg (it is a 100mcg/ml solution)
Intervention Type
Drug
Intervention Name(s)
Midazolam oral solution
Intervention Description
Oral midazolam, 0.5mg/kg (its a 2mg/ml solution)
Intervention Type
Drug
Intervention Name(s)
Oral saline
Other Intervention Name(s)
0.9% Saline solution
Intervention Description
Oral saline, 0.25ml/kg
Intervention Type
Drug
Intervention Name(s)
Nasal saline
Other Intervention Name(s)
0.9% Saline solution
Intervention Description
Nasal saline 0.01ml/kg
Primary Outcome Measure Information:
Title
Emergence agitation
Description
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 Outcome Measure Information:
Title
Bradycardia
Description
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
Title
Hypotension
Description
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
Title
Intraocular pressure
Description
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
Title
Respiratory depression
Description
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
Title
Paradoxal agitation
Description
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).
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel MN Guimarães, MD
Organizational Affiliation
University of Brasilia
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of Brasilia University
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
7000000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Plan to share the database used for analysis, without any variable that may help to identify individuals (such as name, register), to facilitate meta-analysis and re-analysis.

Learn more about this trial

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

We'll reach out to this number within 24 hrs