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

Pain Clinical Trial

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Official title:

Choosing Opioid Management for Pain and Analyzing ACS Rates Equally

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380197
• Other study ID #: 09-076
• Status: Completed
• Phase: Phase 3
• First received: June 22, 2011
• Last updated: January 23, 2018
• Start date: May 26, 2010
• Est. completion date: October 18, 2016

Study information

• Verified date: January 2018
• Source: Children's Healthcare of Atlanta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 18, 2016
• Est. primary completion date: January 14, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 19 Years

Eligibility

Inclusion Criteria:

• Patients with sickle cell disease (SS, SC, SßThal) 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.

Related Conditions & MeSH terms

• Acute Chest Syndrome
• Anemia, Sickle Cell
• Pain
• Sickle Cell Disease

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta	Atlanta Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Chest Syndrome	Number of Participants with Acute Chest Syndrome or A new pulmonry infiltrate on Chest X-ray	3 days
Secondary	Number of Participants Who Experienced Pain Relief		2 days