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NCT00669175 · ClinicalTrials.gov registry record

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

A clinical trial of Pain and Opioid Tolerance, sponsored by Children's Mercy Hospital Kansas City.

Completed
Registry status
25
Enrollment target
1
Study location

NCT00669175 is a study of Pain and Opioid Tolerance that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 25 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00669175, a study of Pain and Opioid Tolerance, has completed, sponsored by Children's Mercy Hospital Kansas City.

COMPLETED
Registry status
25 participants
Enrollment target
1
Study location

Study 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 Studied

Study Locations (1)

Missouri

  • Children's Mercy Hospital - Kansas City

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2008-02
Est. Completion 2011-06

What the Registry Record Tells You About NCT00669175

The ClinicalTrials.gov registry entry for NCT00669175 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (92% lower). The listed sponsor is Children's Mercy Hospital Kansas City, which has 184 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 0 interventions.

NCT00669175 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.

Frequently Asked Questions

What is clinical trial NCT00669175 about?

NCT00669175 is a clinical study titled "Safety and Efficacy of a Low Dose Naloxone Infusion in NICU Patients". 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 d...

What is the current status of trial NCT00669175?

This trial is currently completed. The enrollment target is 25 participants. The study started on 2008-02. Estimated completion is 2011-06.

What conditions does trial NCT00669175 study?

This clinical trial studies the following conditions: Pain, Opioid Tolerance.

Who is sponsoring clinical trial NCT00669175?

This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00669175 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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