Status:
TERMINATED
Inhaled Nitric Oxide for Pediatric Painful Sickle Crisis
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
FDA Office of Orphan Products Development
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
9-22 years
Phase:
PHASE2
Brief Summary
Randomized, double blind placebo controlled clinical trial to evaluate effectiveness and safety of inhaled nitric oxide for the treatment of sickle cell painful crisis in pediatric patients with sickl...
Detailed Description
The specific aim of this study is to evaluate the clinical effectiveness of inhaled nitric oxide (INO) for the treatment of acute vaso-occlusive pain crisis in pediatric patients with sickle cell dise...
Eligibility Criteria
Inclusion
- Hemoglobin SS, Hemoglobin Sß0thal or Hemoglobin SC documented by prior hemoglobin electrophoresis.
- Age 9 years or greater, age 22 years or less; pediatric age range, old enough to comply with mask and give reliable pain assessment score.
- Acute pain crisis defined as pain in abdomen, back and/or extremities that cannot be explained by a diagnosis other than sickle cell disease.
- Initial pain score at least 6 cm; to optimize the likelihood of observing a significant difference in change in pain score between INO treated and placebo groups. Based on data from our previous study, it is anticipated that patients will have an average pre-inhalation pain score of approximately 8 cm.
Exclusion
- \> 24 pain crises in the last 12 months. Patients with very frequent pain crisis may have biologic and/or psychosocial pathophysiology that differs from those with fewer pain crises.
- Pain crisis treated at a medical facility within the last 12 hours.
- Use of investigational drugs other than hydroxyurea within the last 30 days.
- Significant respiratory compromise (initial SaO2 \< 90%) and/or patients likely to have acute chest syndrome (chest pain and infiltrate) will be eliminated.
- Clinically significant acute or chronic cardiac dysfunction.
- Acute priapism.
- New focal neurologic symptoms.
- Concurrent documented or suspected bacterial or parvovirus infection.
- Temperature \> 38.4ºC. These patients may have concomitant infection.
- Transfusion within 30 days or chronic transfusion therapy.
- Pregnant female
- Cigarette smoker \> 1/2 ppd.
- Allergy to morphine
- \-
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00142051
Start Date
April 1 2005
End Date
August 1 2013
Last Update
February 23 2023
Active Locations (1)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115