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
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.
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 in decreased tolerance, less severe withdrawal symptoms, lower cumulative
doses of opiates, and fewer total days of opiates, all while maintaining adequate or
enhanced pain control and sedation. Establishing safety and efficacy data for this
potentially beneficial therapy is an important first step towards using this therapy to
decrease the risk of opioid tolerance and withdrawal in this population of infants.
- 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.
- 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