Safety and Efficacy of a Low Dose Naloxone Infusion in NICU Patients

Completed

Conditions studied: Opioid Tolerance, Pain

In brief

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 time to get the same amount of pain control. When it is time to stop the medicine, the dose has to be decreased slowly so that the patient does not have withdrawal symptoms. Naloxone is a medicine that at high doses can reverse the effects of narcotics. At very small doses it may help prevent tolerance and lessen the severity of withdrawal symptoms. This could mean less narcotic pain medicine is needed over fewer days. The purpose of this research study is to see if giving naloxone to neonates who require narcotic infusions is safe and effective. Safety will be measured by the incidence of side effects. Efficacy will be measured by monitoring for changes in pain and sedation scores and need for more pain medicine.

Key facts

Study ID

NCT00669175

Run by

Children's Mercy Hospital Kansas City

People needed

25

Starts

2008-02-01

Expected to finish

2011-06-01

Last updated by the study team

2011-07-21

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Children's Mercy Hospital — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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