Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally (COMPARE)
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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 |
- Acute Chest Syndrome [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]A new pulmonry infiltrate on Chest X-ray
- 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 |
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| United States, Georgia | |
| Children's Healthcare of Atlanta | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: Iris Buchanan, MD 404-398-9578 ibuchanan@msm.edu | |
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 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 Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics Narcotic Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013