Status:
COMPLETED
Safety and Efficacy of a Low Dose Naloxone Infusion in NICU Patients
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Opioid Tolerance
Pain
Eligibility:
All Genders
1-30 years
Brief Summary
When narcotic pain medicine, like fentanyl or morphine, is given to adults and children for several days, they often develop a tolerance to the medicine. This means they may need higher doses over tim...
Detailed Description
This is a prospective, non-randomized, single center, open label dose escalation study. We hypothesize that critically ill patients in the NICU may benefit from a low dose naloxone infusion resulting ...
Eligibility Criteria
Inclusion
- Neonates \> 36 0/7 weeks estimated gestational age
- Less than 30 days of life
- Requiring admission to to the Neonatal Intensive Care Unit
- Requiring continuous infusions of fentanyl or morphine analgesia
- Anticipated to require opioid infusions for at least four days
- Patients must be enrolled within 120 hours of initiating opioid infusions
- All patients will also require mechanical ventilation prior to study entry.
Exclusion
- Preterm infants \< 36 weeks gestation
- Neonates with major neurologic anomalies, seizures
- Opioid infusion administration for \> 120 hours prior to study entry
- Patients requiring ECMO support prior to study entry
- Neonates born to mothers who are known to be opioid dependent
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00669175
Start Date
February 1 2008
End Date
June 1 2011
Last Update
July 21 2011
Active Locations (1)
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1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108