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Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age

NCT01159262 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-08-13

Study results available
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Summary

The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to 24 hours in the neonatal intensive care unit (NICU), cardiac intensive care unit (CICU), or pediatric intensive care unit (PICU).

Conditions

  • Sedation

Interventions

DRUG

Midazolam

Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion

DRUG

Fentanyl/Morphine

Per package insert, N-PASS scores and investigator discretion.

DRUG

Dexmedetomidine

Sponsors & Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
44 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States
  • Guatemala

Study Locations

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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 NCT01159262 on ClinicalTrials.gov