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

This study has been completed.

Sponsor:

Information provided by:

Children's Mercy Hospital Kansas City

ClinicalTrials.gov Identifier:

NCT00669175

First received: April 24, 2008

Last updated: July 19, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 24, 2008

Last Updated Date

July 19, 2011

Start Date ^ICMJE

February 2008

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00669175 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

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 ^ICMJE

Opioid Tolerance
Pain

Intervention ^ICMJE

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.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2011

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

up to 30 Days (Child)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00669175

Other Study ID Numbers ^ICMJE

08 01-003

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Eugenia Pallotto, Children's Mercy Hospital

Study Sponsor ^ICMJE

Children's Mercy Hospital Kansas City

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Eugenia K Pallotto, MD

Children's Mercy Hospital

PRS Account

Children's Mercy Hospital Kansas City

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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