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

NCT01380197 | Completed Phase 3 Results

• 1 other identifier: 09-076
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Sickle Cell Disease

Keywords

pain; sickle cell; nubain; morphine; acute chest; side effects

Outcome Measures

Primary Outcomes (1)

• Acute Chest Syndrome

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

  3 days

Secondary Outcomes (1)

• Number of Participants Who Experienced Pain Relief

  2 days

Study Arms (2)

Randomizing particiipants to Morphine

ACTIVE COMPARATOR

Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis

Drug: Morphine

Randomization to Nubain

ACTIVE COMPARATOR

Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients

Drug: Nubain

Interventions

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).

Randomizing particiipants to Morphine

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).

Randomization to Nubain

Eligibility Criteria

• Age: 6 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Healthcare of Atlanta: lead
• Atlanta Clinical and Translational Science Institute: collaborator

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

Pain; Anemia, Sickle Cell

Interventions

Morphine; Nalbuphine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Iris Buchanan
• Organization: Morehouse School of Medicine

ibuchanan@msm.edu

404-398-9578

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Iris Buchanan MD

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 27, 2011
• Study Start: May 26, 2010
• Primary Completion: January 14, 2014
• Study Completion: October 18, 2016
• Last Updated: February 20, 2018
• Results First Posted: February 16, 2015

Record last verified: 2018-01

Locations

US (1)