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

NCT00669175 | Completed

• 1 other identifier: 08 01-003
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Tolerance; Pain

Keywords

Naloxone; Neonate; Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Before, during, and after administration of naloxone

Secondary Outcomes (1)

• 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.

  Collected and compared for the time period before, during, and for 5 days after naloxone infusion is administered

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eugenia K Pallotto, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 29, 2008
• Study Start: February 1, 2008
• Study Completion: June 1, 2011
• Last Updated: July 21, 2011

Record last verified: 2011-07

Locations

US (1)