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Effects of Dexmedetomidine on the Postoperative Experience in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01748630
First Posted: December 12, 2012
Last Update Posted: December 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr Mustafasaid, Inonu University
  Purpose

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.


Condition Intervention Phase
Failed Moderate Sedation During Procedure Drug: dexmedetomidine Drug: Midazolam Drug: fentanyl Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pain, Fentanyl Consumption, and Delirium in Children After Scoliosis Surgery: Dexmedetomidine Versus Midazolam

Resource links provided by NLM:


Further study details as provided by Dr Mustafasaid, Inonu University:

Primary Outcome Measures:
  • fentanyl consumption [ Time Frame: 1 hour ]
  • fentanyl consumption [ Time Frame: 2 hours ]
  • fentanyl consumption [ Time Frame: 4 hours ]
  • fentanyl consumption [ Time Frame: 6 hours ]
  • fentanyl consumption [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • incidence of delirium [ Time Frame: 1, 2, 4 ,6 and 24 hours ]

Other Outcome Measures:
  • heart rate [ Time Frame: 1, 2, 4 ,6 and 24 hours ]

Enrollment: 42
Study Start Date: February 2012
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexmedetomidine, Midazolam
dexmedetomidine (group DEX); starting dose, 0.4 μg•kg-1•h-1,with intermittent fentanyl
Drug: dexmedetomidine Drug: fentanyl
Active Comparator: Midazolam
midazolam (group MDZ); starting dose, 0.1 mg•kg-1•h-1
Drug: Midazolam Drug: fentanyl

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748630


Locations
Turkey
Inonu University Turgut Ozal Medical Center
Malatya, Turkey, 44280
Sponsors and Collaborators
Inonu University
  More Information

Responsible Party: Dr Mustafasaid, Assist. Prof., Inonu University
ClinicalTrials.gov Identifier: NCT01748630     History of Changes
Other Study ID Numbers: TOTM_Anaesthesia_MSA1
First Submitted: November 30, 2012
First Posted: December 12, 2012
Last Update Posted: December 12, 2012
Last Verified: December 2012

Keywords provided by Dr Mustafasaid, Inonu University:
scoliosis, sedation, children, fentanyl consumption, pain

Additional relevant MeSH terms:
Dexmedetomidine
Midazolam
Fentanyl
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents