Phase 3
N=40
Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally
Pain · Sickle Cell Disease
Bottom Line
View on ClinicalTrials.gov: NCT01380197 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Acute Chest Syndrome — 2; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Morphine (Drug); Nubain (Drug)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- Children's Healthcare of Atlanta
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Chest Syndrome |
2; 1 | — |
| SECONDARY Number of Participants Who Experienced Pain Relief |
2; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients with sickle cell disease (SS, SC, SβThal) who are hospitalized for acute painful episodes
- 6 years old and 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.
Data sourced from ClinicalTrials.gov (NCT01380197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.