Status:
WITHDRAWN
Comparison of Patient Controlled Analgesia (PCA) Versus Bolus Narcotic Therapy for the Treatment of Vaso-Occlusive Crisis (VOC)
Lead Sponsor:
Johns Hopkins University
Conditions:
Sickle Cell Disease
Vaso-occlusive Crisis
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
This research is being done to find out the best way to give narcotics for pain relief in adults with sickle cell disease and painful crisis. This study is a comparison of two ways of giving narcotics...
Eligibility Criteria
Inclusion
- Documented sickle cell disease
- Signed consent in outpatient clinic or during a prior hospitalization
- 18+ years of age
- Seen in the ED with sickle cell pain crisis - this will be based on patients chief complaint that they are in a VOC.
- Requires IV administration of narcotics (has failed oral narcotic therapy at home)
- Must be 2 weeks since their last randomization on this study.
Exclusion
- Contraindication to the use of IV narcotics
- Hypotension with systolic blood pressure (SBP) ≤ 90
- Respiratory rate ≤9
- Altered mental status
- Patient unable to understand how to use the PCA device
- Patient unwilling to use PCA device
- Pulse oximeter reading of ≤ 94% on room air
- Patient is allergic to IV morphine \& hydromorphone \& fentanyl.
- Patient is allergic to oral hydromorphone \& morphine \& oxycodone
- Patient has been randomized on this study 3 times before
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00711698
Start Date
September 1 2007
End Date
September 1 2009
Last Update
March 24 2017
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205