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The Efficacy and the Safety of Dexmedetomidine Sedation on the Pediatric Intensive Unit(PICU) Patients.

NCT02296073 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-11-21

No results posted yet for this study

Summary

To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to the pediatric intensive care unit after surgery.

Conditions

  • Failed Conscious Sedation During Procedure

Interventions

DRUG

Midazolam

midazolam 3～5μg/kg•min for maintenance of sedation.

DRUG

Dexmedetomidine

Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；

DRUG

Dexmedetomidine

Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；

DRUG

Dexmedetomidine

Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation；

DRUG

Fentanyl

Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia

OTHER

assessment

Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment.

Sponsors & Collaborators

  • Anhui Provincial Children's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2014-12-31
Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02296073 on ClinicalTrials.gov