Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01380197 · ClinicalTrials.gov registry record · Phase 3

Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally

A Phase 3 study, sponsored by Children's Healthcare of Atlanta.

Completed
Registry status
Phase 3
Development phase
40
Enrollment target

NCT01380197 is a Phase 3 study that has completed, run by Children's Healthcare of Atlanta. The registered enrollment target is 40 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01380197, a Phase 3 study, has completed, sponsored by Children's Healthcare of Atlanta.

COMPLETED
Registry status
Phase 3
Development phase
40 participants
Enrollment target

Study Summary

The pathophysiology of sickle cell disease (SCD) manifestations, are complex with interactions of intracellular hemoglobin, membrane and endothelial activation but the hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful episodes are thought to result from ischemia caused when small blood vessels are occluded by misshapen, inflexible erythrocytes. Painful episodes are the most common cause of hospitalization, morbidity, and impairment for SCD patients. There is no therapy that completely prevents or directly aborts painful events for all patients. Consequently, treatment for acute VOC is primarily supportive using hydration and medicinal pain control. Every pain medication has the potential to relieve pain but is associated with significant limitations and side effects. The primary hypothesis to be tested in this double blind, randomized controlled trial is that Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer episodes of acute chest syndrome. The investigators also expect subjects will report fewer side effects from respiratory depression, abdominal distention from reduced peristalsis, reduced histamine release causing pruritis and still be provided adequate pain control. Further hypotheses to be tested is ability to recruit patient participants while being treated in the Emergency Department and that continuous infusion of Nalbuphine with accompanying patient controlled analgesia (PCA) is safe and effective in controlling pain, requiring less total opiates consumption, while decreasing length of hospitalization.

Interventions

  • DRUG Morphine
  • DRUG Nubain

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2010-05-26
Est. Completion 2016-10-18
Phase Phase 3

Sponsor

Children's Healthcare of Atlanta

80 total trials

What the Registry Record Tells You About NCT01380197

The ClinicalTrials.gov registry entry for NCT01380197 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Healthcare of Atlanta, which has 80 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Morphine is the first listed.

NCT01380197 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01380197 about?

NCT01380197 is a clinical study titled "Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally". The pathophysiology of sickle cell disease (SCD) manifestations, are complex with interactions of intracellular hemoglobin, membrane and endothelial activation but the hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful episodes are thought to result from ischemia cau...

What is the current status of trial NCT01380197?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2010-05-26. Estimated completion is 2016-10-18.

What interventions are being tested in trial NCT01380197?

The interventions under investigation include: Morphine (DRUG), Nubain (DRUG).

Who is sponsoring clinical trial NCT01380197?

This trial is sponsored by Children's Healthcare of Atlanta, which has 80 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.