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Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children

U

Ullevaal University Hospital

Status and phase

Unknown
Phase 3

Conditions

Sedation

Treatments

Drug: dexmedetomidine
Drug: Midazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT01091818
dexmedetmidazchildintsed

Details and patient eligibility

About

Dexmedetomidine will be tested against midazolam in a prospective, randomized, double-blind study of intensive care children, age 2-17 years.

The investigators' primary hypothesis is that time from end of medication to extubation will be shorter with dexmedetomidine sedation.

Enrollment

40 estimated patients

Sex

All

Ages

2 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • informed consent from parents
  • age between 2 and 18 years
  • anticipated need of respirator treatment for more than 24 hrs
  • included in study within 48 hrs of admission to intensive care unit (ICU)

Exclusion criteria

  • severe, unstable circulatory failure
  • severe intracranial or spinal trauma with circulatory instability
  • sever bradycardia or atrioventricular (A-V) block
  • liver failure
  • less than 50% chance of anticipated survival
  • known allergy to study drugs

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups

midazolam
Active Comparator group
Treatment:
Drug: Midazolam
dexmedetomidin
Experimental group
Treatment:
Drug: dexmedetomidine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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