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NCT Number: NCT01380197

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 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.

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Key information

Conditions

Pain Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sickle Cell Disease Signs and Symptoms

Age range

6 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30303, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Morphine

Drug

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).

Nubain

Drug

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).

Primary outcomes

  1. Acute Chest Syndrome

    Time frame: 3 days

    Number of Participants with Acute Chest Syndrome or A new pulmonry infiltrate on Chest X-ray

Secondary outcomes

  1. Number of Participants Who Experienced Pain Relief

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Children's Healthcare of Atlanta

Other

Collaborators

  • Atlanta Clinical and Translational Science Institute

Registry information

Official study title

Choosing Opioid Management for Pain and Analyzing ACS Rates Equally

Acronym: COMPARE

Important dates

Study start
2010
Primary completion
2014
Study completion
2016
First posted
Jun 27, 2011
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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