Safety and Efficacy of a Low Dose Naloxone Infusion in NICU Patients
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ClinicalTrials.gov Identifier: NCT00669175 |
Recruitment Status
:
Completed
First Posted
: April 29, 2008
Last Update Posted
: July 21, 2011
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Tracking Information | ||||
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First Submitted Date | April 24, 2008 | |||
First Posted Date | April 29, 2008 | |||
Last Update Posted Date | July 21, 2011 | |||
Study Start Date | February 2008 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures |
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 ] | |||
Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT00669175 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
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 ] | |||
Original Secondary Outcome Measures | Same as current | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Safety and Efficacy of a Low Dose Naloxone Infusion in NICU Patients | |||
Official Title | Safety and Efficacy of a Low Dose Naloxone Infusion in NICU Patients | |||
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 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. |
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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. | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | Neonates admitted to the NICU within the first five days of life with an anticipated need for opiate infusion for at least four days | |||
Condition |
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Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Estimated Enrollment |
25 | |||
Original Estimated Enrollment | Same as current | |||
Actual Study Completion Date | June 2011 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | up to 30 Days (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00669175 | |||
Other Study ID Numbers | 08 01-003 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Eugenia Pallotto, Children's Mercy Hospital | |||
Study Sponsor | Children's Mercy Hospital Kansas City | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Children's Mercy Hospital Kansas City | |||
Verification Date | July 2011 |