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

Failed Conscious Sedation During Procedure Clinical Trial

Official title:

The Efficacy and the Safety of Dexmedetomidine Sedation on the PICU Patients-A Randomized, Controlled Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02296073
• Other study ID #: PICUDEX2014
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 17, 2014
• Last updated: November 19, 2014
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2014
• Source: Anhui Provincial Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 16 Years

Eligibility

Inclusion Criteria:

1. written informed consent;

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:

1. congenital heart disease, arrhythmias and heart failure;

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; -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Failed Conscious Sedation During Procedure

Intervention

Drug:
• 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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Provincial Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of time at target sedation score	assess the sedation level every 2 min using Ramsay score	up to 24 hours	No
Primary	the number of patients requiring the sedation remedy	the number of patients requiring the sedation remedy during the mechanical ventilation	up to 24 hours	No
Primary	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	No
Secondary	change of blood pressure	the change of blood pressure at 1 min?10 min?20 min?30 min?1 hours?2 hours?3 hours?4 hours?5 hours?6 hours?12 hours?18 hours?24 hours after the sedation drug used.	up to 24 hours.	Yes
Secondary	change of heart rate	the change of heart rate at 1 min?10 min?20 min?30 min?1 hours?2 hours?3 hours?4 hours?5 hours?6 hours?12 hours?18 hours?24 hours after the sedation drug used.	up to 24 hours	Yes
Secondary	change of respiratory rate	the change of respiratory rate at 1 min?10 min?20 min?30 min?1 hours?2 hours?3 hours?4 hours?5 hours?6 hours?12 hours?18 hours?24 hours after the sedation drug used.	up to 24 hours	Yes
Secondary	change of blood oxygen saturation	the change of blood oxygen saturation at 1 min?10 min?20 min?30 min?1 hours?2 hours?3 hours?4 hours?5 hours?6 hours?12 hours?18 hours?24 hours after the sedation drug used.	up to 24 hours	Yes
Secondary	extubation time	time from beginning of study drug used to extubation	up to 24 hours	Yes
Secondary	change of hepatic function	change of blood ALT?AST level at baseline and 24 hours after the sedation drug used.	up to 24 hours	Yes
Secondary	change of renal function	change of blood Cr?BUN level at baseline and 24 hours after the sedation drug used.	up to 24 hours	Yes
Secondary	the dosage of sedation and analgesia drug	the total dosage of sedation and analgesia drug during the sedation and analgesia period	up to 24 hours	No
Secondary	the number of patients requiring fentanyl analgesia in and after 6 hours from study drug used		up to 24 hours	No
Secondary	the dosage of fentanyl in and after 6 hours from study drug used		up to 24 hours	No