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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
  Purpose

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
Opioid Tolerance
Pain

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Safety and Efficacy of a Low Dose Naloxone Infusion in NICU Patients

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: February 2008
Study Completion Date: June 2011
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.

  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669175

Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Eugenia K Pallotto, MD Children's Mercy Hospital
  More Information

No publications provided

Responsible Party: Eugenia Pallotto, Children's Mercy Hospital
ClinicalTrials.gov Identifier: NCT00669175     History of Changes
Other Study ID Numbers: 08 01-003
Study First Received: April 24, 2008
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Naloxone
Neonate
Pain

Additional relevant MeSH terms:
Naloxone
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014