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Effects of Dexmedetomidine on the Postoperative Experience in Children

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. Identifier: NCT01748630
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : December 12, 2012
Information provided by (Responsible Party):
Dr Mustafasaid, Inonu University

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.

Condition or disease Intervention/treatment Phase
Failed Moderate Sedation During Procedure Drug: dexmedetomidine Drug: Midazolam Drug: fentanyl Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
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
Study Start Date : February 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium Scoliosis

Arm Intervention/treatment
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

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

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

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

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

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.

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 identifier (NCT number): NCT01748630

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Inonu University Turgut Ozal Medical Center
Malatya, Turkey, 44280
Sponsors and Collaborators
Inonu University
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Responsible Party: Dr Mustafasaid, Assist. Prof., Inonu University Identifier: NCT01748630    
Other Study ID Numbers: TOTM_Anaesthesia_MSA1
First Posted: December 12, 2012    Key Record Dates
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:
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Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
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
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs