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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00669175
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : July 21, 2011
Information provided by:
Children's Mercy Hospital Kansas City

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.

Condition or disease
Opioid Tolerance Pain

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
Estimated Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  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. [ Time Frame: Before, during, and after administration of naloxone ]

Secondary Outcome Measures :
  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. [ Time Frame: Collected and compared for the time period before, during, and for 5 days after naloxone infusion is administered ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00669175

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

Responsible Party: Eugenia Pallotto, Children's Mercy Hospital Identifier: NCT00669175     History of Changes
Other Study ID Numbers: 08 01-003
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: July 21, 2011
Last Verified: July 2011

Keywords provided by Children's Mercy Hospital Kansas City:

Additional relevant MeSH terms:
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents