Effects of Dexmedetomidine on the Postoperative Experience in Children

Study Overview
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Brief Summary
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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.

Official Title
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Pain, Fentanyl Consumption, and Delirium in Children After Scoliosis Surgery: Dexmedetomidine Versus Midazolam

Conditions
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Failed Moderate Sedation During Procedure

Intervention / Treatment
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* Drug: dexmedetomidine
* Drug: Midazolam
* Drug: fentanyl


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine, Midazolam<br>dexmedetomidine (group DEX); starting dose, 0.4 μg•kg-1•h-1,with intermittent fentanyl | Drug: dexmedetomidine<br> <br> Drug: fentanyl<br> <br> |
| Active Comparator: Midazolam<br>midazolam (group MDZ); starting dose, 0.1 mg•kg-1•h-1 | Drug: Midazolam<br> <br> Drug: fentanyl<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fentanyl consumption |  | 1 hour | 
| fentanyl consumption |  | 2 hours | 
| fentanyl consumption |  | 4 hours | 
| fentanyl consumption |  | 6 hours | 
| fentanyl consumption |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of delirium |  | 1, 2, 4 ,6 and 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scoliosis, sedation, children, fentanyl consumption, pain