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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2009 by Children's Healthcare of Atlanta
Sponsor:
Collaborator:
Atlanta Clinical and Translational Science Institute
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT01380197
First received: June 22, 2011
Last updated: March 14, 2012
Last verified: September 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Children's Healthcare of Atlanta:

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


Secondary Outcome Measures:
  • Pain relief [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: May 2010
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   6 Years to 19 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380197

Locations
United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30303
Contact: Iris Buchanan, MD    404-398-9578    ibuchanan@msm.edu   
Sponsors and Collaborators
Children's Healthcare of Atlanta
Atlanta Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Iris Buchanan, MD, MSc., Morehouse School of Medicine
ClinicalTrials.gov Identifier: NCT01380197     History of Changes
Other Study ID Numbers: 09-076
Study First Received: June 22, 2011
Last Updated: March 14, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014