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Your journey
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More info
You can access this
clinical trial
if you have
Failed Moderate Sedation During Procedure
and you are
between 12 and 18
years old
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
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The 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.

Provided treatments

  • Drug: dexmedetomidine
  • Drug: Midazolam
  • Drug: fentanyl

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01748630. The sponsor of the trial is Inonu University and it is looking for 42 volunteers for the current phase.
Official trial title:
Pain, Fentanyl Consumption, and Delirium in Children After Scoliosis Surgery: Dexmedetomidine Versus Midazolam