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Effects of Dexmedetomidine on the Postoperative Experience in Children

Primary Purpose

Failed Moderate Sedation During Procedure

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
dexmedetomidine
Midazolam
fentanyl
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failed Moderate Sedation During Procedure focused on measuring scoliosis, sedation, children, fentanyl consumption, pain

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

admittance to the ICU and a requirement of mechanical ventilation with an endotracheal tube.

Exclusion Criteria:

Patients who had a history of allergies to midazolam and/or dexmedetomidine; delirium, developmental delay, or mental retardation, as reported by parents; an American Society of Anesthesiologists classification greater than III; any known previous reactions to anesthesia; or a history of asthma or an anticipated difficult airway and concomitant disease (neuromuscular scoliosis or neurodegenerative disease) were excluded from the study.

Sites / Locations

  • Inonu University Turgut Ozal Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dexmedetomidine, Midazolam

Midazolam

Arm Description

dexmedetomidine (group DEX); starting dose, 0.4 μg•kg-1•h-1,with intermittent fentanyl

midazolam (group MDZ); starting dose, 0.1 mg•kg-1•h-1

Outcomes

Primary Outcome Measures

fentanyl consumption
fentanyl consumption
fentanyl consumption
fentanyl consumption
fentanyl consumption

Secondary Outcome Measures

incidence of delirium

Full Information

First Posted
November 30, 2012
Last Updated
December 11, 2012
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT01748630
Brief Title
Effects of Dexmedetomidine on the Postoperative Experience in Children
Official Title
Pain, Fentanyl Consumption, and Delirium in Children After Scoliosis Surgery: Dexmedetomidine Versus Midazolam
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: The study aim was to compare the efficacy of dexmedetomidine versus midazolam for sedation during the early postoperative period in children who underwent scoliosis surgery. Methods: We performed a prospective, randomized trial in an intensive care unit (ICU) in a tertiary care center. In this study, 42 patients (American Society of Anesthesiology physical status I and II) who underwent scoliosis surgery were divided into 2 groups according to sedation protocols: group DEX (n = 22) and group MDZ (n = 20). Children (12-18 years) requiring mechanical ventilation underwent a continuous infusion of either dexmedetomidine (group DEX; starting dose, 0.4 μg•kg-1•h-1) or midazolam (group MDZ; starting dose, 0.1 mg•kg-1•h-1) with intermittent fentanyl, as needed. The efficacy of sedation was assessed using the Richmond Agitation Sedation Scale (RASS). Quality of pain relief was measured using the Numeric Visual Analog Scale (NVAS). During the arousal assessment, delirium was determined in patients in the RASS range of -2 to +1 using the Confusion Assessment Method for the ICU (CAM-ICU). Fentanyl consumption, incidence of delirium, NVAS scores, and hemodynamics were recorded postoperatively at 2, 4, 6, and 24 h in the ICU.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Moderate Sedation During Procedure
Keywords
scoliosis, sedation, children, fentanyl consumption, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine, Midazolam
Arm Type
Active Comparator
Arm Description
dexmedetomidine (group DEX); starting dose, 0.4 μg•kg-1•h-1,with intermittent fentanyl
Arm Title
Midazolam
Arm Type
Active Comparator
Arm Description
midazolam (group MDZ); starting dose, 0.1 mg•kg-1•h-1
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Type
Drug
Intervention Name(s)
fentanyl
Primary Outcome Measure Information:
Title
fentanyl consumption
Time Frame
1 hour
Title
fentanyl consumption
Time Frame
2 hours
Title
fentanyl consumption
Time Frame
4 hours
Title
fentanyl consumption
Time Frame
6 hours
Title
fentanyl consumption
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
incidence of delirium
Time Frame
1, 2, 4 ,6 and 24 hours
Other Pre-specified Outcome Measures:
Title
heart rate
Time Frame
1, 2, 4 ,6 and 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: admittance to the ICU and a requirement of mechanical ventilation with an endotracheal tube. Exclusion Criteria: Patients who had a history of allergies to midazolam and/or dexmedetomidine; delirium, developmental delay, or mental retardation, as reported by parents; an American Society of Anesthesiologists classification greater than III; any known previous reactions to anesthesia; or a history of asthma or an anticipated difficult airway and concomitant disease (neuromuscular scoliosis or neurodegenerative disease) were excluded from the study.
Facility Information:
Facility Name
Inonu University Turgut Ozal Medical Center
City
Malatya
ZIP/Postal Code
44280
Country
Turkey

12. IPD Sharing Statement

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Effects of Dexmedetomidine on the Postoperative Experience in Children

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