We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01380197
First Posted: June 27, 2011
Last Update Posted: September 16, 2016
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.
Collaborator:
Atlanta Clinical and Translational Science Institute
Information provided by (Responsible Party):
Saadia Khizer, Children's Healthcare of Atlanta
  Purpose

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.


Condition Intervention Phase
Pain Sickle Cell Disease Drug: Morphine Drug: Nubain Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Choosing Opioid Management for Pain and Analyzing ACS Rates Equally

Resource links provided by NLM:


Further study details as provided by Saadia Khizer, Children's Healthcare of Atlanta:

Primary Outcome Measures:
  • Acute Chest Syndrome [ Time Frame: 3 days ]
    A new pulmonry infiltrate on Chest X-ray


Secondary Outcome Measures:
  • Pain Relief [ Time Frame: 2 days ]

Enrollment: 40
Study Start Date: May 2010
Estimated Study Completion Date: January 2018
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Randomizing particiipants to Morphine
Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis
Drug: Morphine

Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.

Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).

Active Comparator: Randomization to Nubain
Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients
Drug: Nubain

Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.

Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).


  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with sickle cell disease (SS, SC, SβThal) who are hospitalized for acute painful episodes
  • 6 years old and < 19 years old
  • Normal baseline chest radiograph
  • Normal renal and hepatic function within the previous 12 months

Exclusion Criteria:

  • Previous patient participation in this clinical trial
  • Any patient on chronic transfusion Any patient with pulmonary infiltrate on chest radiograph on admission
  • Any patient with DSM diagnosis, excluding those with Attention Deficit Disorder, on or off treatment
  • Any patient with documented allergy to either study drug
  • Any patient with known evidence of an underlying disease that would interfere with evaluation of a therapeutic response such as:

    • Hepatic dysfunction (3x ALT),
    • Renal dysfunction (Cr > 1 children/adolescents, Cr >2 adults),
    • Pulmonary Hypertension (TRJ >3.0),
    • Cardiac dysfunction.
    • Any patient with symptoms of an acute stroke.
    • Any patient known or suspected to be pregnant.
    • Any patient with priapism
    • The patient or guardian who will not give consent or assent to be randomized.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01380197


Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Children's Healthcare of Atlanta
Atlanta Clinical and Translational Science Institute
  More Information

Responsible Party: Saadia Khizer, Iris Buchanan MD, Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT01380197     History of Changes
Other Study ID Numbers: 09-076
First Submitted: June 22, 2011
First Posted: June 27, 2011
Results First Submitted: February 2, 2015
Results First Posted: February 16, 2015
Last Update Posted: September 16, 2016
Last Verified: August 2016

Keywords provided by Saadia Khizer, Children's Healthcare of Atlanta:
pain
sickle cell
nubain
morphine
acute chest
side effects

Additional relevant MeSH terms:
Anemia, Sickle Cell
Acute Chest Syndrome
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Morphine
Nalbuphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists