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

NCT02296073 | Unknown Phase 4

• 1 other identifier: PICUDEX2014
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Pediatric intensive care unit; Sedation; Dexmedetomidine; mechanical ventilation

Outcome Measures

Primary Outcomes (3)

• percentage of time at target sedation score

  assess the sedation level every 2 min using Ramsay score

  up to 24 hours

• the number of patients requiring the sedation remedy

  the number of patients requiring the sedation remedy during the mechanical ventilation

  up to 24 hours

• the dosage of midazolam that need for the sedation remedy

  the dosage of midazolam that need for sedation remedy during the mechanical ventilation

  up to 24 hours

Secondary Outcomes (10)

• change of blood pressure

  up to 24 hours.

• change of heart rate

  up to 24 hours

• change of respiratory rate

  up to 24 hours

• change of blood oxygen saturation

  up to 24 hours

• extubation time

  up to 24 hours

Study Arms (4)

Midazolam

EXPERIMENTAL

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

Drug: Midazolam; Drug: Fentanyl; Other: assessment

Dexmedetomidine1

EXPERIMENTAL

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

Drug: Dexmedetomidine; Drug: Fentanyl; Other: assessment

Dexmedetomidine2

EXPERIMENTAL

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

Drug: Dexmedetomidine; Drug: Fentanyl; Other: assessment

Dexmedetomiding3

EXPERIMENTAL

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

Drug: Dexmedetomidine; Drug: Fentanyl; Other: assessment

Interventions

Midazolam DRUG

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

Also known as: Liyuexi

Midazolam

Dexmedetomidine DRUG

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

Also known as: Yisi

Dexmedetomidine1

Fentanyl DRUG

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

Also known as: Fentai

Dexmedetomidine1; Dexmedetomidine2; Dexmedetomiding3; Midazolam

assessment OTHER

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

Dexmedetomidine1; Dexmedetomidine2; Dexmedetomiding3; Midazolam

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• written informed consent；
• pediatric patients admitted to intensive care unit after general anesthesia;
• expected mechanical ventilation time \>6 hours; （4）1 months to 16 years old; -

You may not qualify if:

• congenital heart disease, arrhythmias and heart failure;
• Alanine transaminase（ALT） and (or) Aspartate aminotransferase（AST） level is more than twice the upper limit of normal;
• Creatinine and (or) Blood urea nitrogen（BUN） is more than the upper limit of normal;
• central nervous system disease;
• spinal analgesia or muscle relaxants is used during PICU;
• the drug that affects the nerve conduction is used in one month;
• allergy to the test drug or having other contraindications;
• participated in other studies 30 days prior to admission of PICU; -

Sponsors & Collaborators

• Anhui Provincial Children's Hospital: lead

MeSH Terms

Interventions

Midazolam; Dexmedetomidine; Fentanyl; Restraint, Physical

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Piperidines; Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia Department

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 20, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: November 21, 2014

Record last verified: 2014-11