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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669175
• Other study ID #: 08 01-003
• Status: Completed
• Phase: N/A
• First received: April 24, 2008
• Last updated: July 19, 2011
• Start date: February 2008
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Opioid Tolerance
• Pain

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes