Safety and Efficacy of a Low Dose Naloxone Infusion in NICU Patients
|ClinicalTrials.gov Identifier: NCT00669175|
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : July 21, 2011
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.
|Condition or disease|
|Opioid Tolerance Pain|
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||Safety and Efficacy of a Low Dose Naloxone Infusion in NICU Patients|
|Study Start Date :||February 2008|
|Actual Study Completion Date :||June 2011|
- The primary outcome variable will be a change in N-PASS scores. N-PASS scores will be compared before, during, and after administration of naloxone. [ Time Frame: Before, during, and after administration of naloxone ]
- The secondary outcome variable will be any changes in dosing of opioids within four hours of initiating or increasing naloxone infusion. Vital signs will be recorded per NICU protocol and closely monitored for changes. [ Time Frame: Collected and compared for the time period before, during, and for 5 days after naloxone infusion is administered ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669175
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Eugenia K Pallotto, MD||Children's Mercy Hospital|