The Efficacy and the Safety of Dexmedetomidine Sedation on the Pediatric Intensive Unit(PICU) Patients.
NCT ID: NCT02296073
Last Updated: 2014-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2014-12-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Midazolam
midazolam 3～5μg/kg•min for maintenance of sedation.
Midazolam
midazolam 3～5μg/kg•min for maintenance of sedation.
Fentanyl
Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia
assessment
Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment.
Dexmedetomidine1
Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
Dexmedetomidine
Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
Fentanyl
Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia
assessment
Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment.
Dexmedetomidine2
Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
Dexmedetomidine
Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
Fentanyl
Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia
assessment
Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment.
Dexmedetomiding3
Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation；
Dexmedetomidine
Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation；
Fentanyl
Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia
assessment
Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment.
Interventions
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Midazolam
midazolam 3～5μg/kg•min for maintenance of sedation.
Dexmedetomidine
Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
Dexmedetomidine
Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
Dexmedetomidine
Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation；
Fentanyl
Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia
assessment
Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. pediatric patients admitted to intensive care unit after general anesthesia;
3. expected mechanical ventilation time \>6 hours; （4）1 months to 16 years old; -
Exclusion Criteria
2. Alanine transaminase（ALT） and (or) Aspartate aminotransferase（AST） level is more than twice the upper limit of normal;
3. Creatinine and (or) Blood urea nitrogen（BUN） is more than the upper limit of normal;
4. central nervous system disease;
5. spinal analgesia or muscle relaxants is used during PICU;
6. the drug that affects the nerve conduction is used in one month;
7. allergy to the test drug or having other contraindications;
8. participated in other studies 30 days prior to admission of PICU; -
1 Month
16 Years
ALL
No
Sponsors
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Anhui Provincial Children's Hospital
OTHER
Responsible Party
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Yuanyuan Xu
Anesthesia Department
Other Identifiers
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PICUDEX2014
Identifier Type: -
Identifier Source: org_study_id