NCT00669175

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 1 Day – 30 Days
• Healthy volunteers: Not accepted

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 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.

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 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.

Conditions

• Opioid Tolerance
• Pain

Timeline

• Start date: 2008-02-01
• Completion: 2011-06-01
• First posted: 2008-04-29
• Last updated: 2011-07-21

Locations

1 site across 1 country: United States