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Completed

NCT Number: NCT01748630

Effects of Dexmedetomidine on the Postoperative Experience in Children

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Inonu University Turgut Ozal Medical Center

Malatya, 44280, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

midazolam

Drug

Fentanyl

Drug

Primary outcomes

  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 outcomes

  1. incidence of delirium

    Time frame: 1, 2, 4 ,6 and 24 hours

Other outcomes

  1. heart rate

    Time frame: 1, 2, 4 ,6 and 24 hours

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 12, 2012
Registry last updated
Dec 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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