Comparison of Patient Controlled Analgesia (PCA) Versus Bolus Narcotic Therapy for the Treatment of Vaso-Occlusive Crisis (VOC)
Withdrawn before enrolling · Phase 2
Conditions studied: Sickle Cell Disease, Vaso-occlusive Crisis
In brief
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. The first way is what occurs now in the Emergency Acute Care Unit (EACU) where patients are given a single intravenous (iv) dose of a narcotic which is repeated by the nurse as needed to control the pain. The second way is to provide a single iv dose of narcotic and then allow the patient to push a button and receive one or more additional doses of narcotic when he/she thinks it is needed. Our hypothesis is that PCA will be a more effective way of controlling pain.
Key facts
- Study ID
- NCT00711698
- Run by
- Johns Hopkins University
- People needed
- 0
- Starts
- 2007-09-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2017-03-24
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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