Sickle Cell Disease Clinical Trial
Official title:
PCA for Pain Control in Adults With Sickle Cell Disease in the Emergency Department (ED) Decreases Admission Rates Over Standard Bolus Therapy
Verified date | March 2017 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 1, 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decrease in admissions for those treated with a PCA in the ED v those that are given bolus narcotic dosing | Measured at time of discharge from ED | ||
Secondary | Length of stay | Endpoints will be the time at which the decision for discharge from the EACU or transfer from the EACU to inpatient admission to the hospital is made | ||
Secondary | Total narcotic used | Endpoints will be the time at which the decision for discharge from the EACU or transfer from the EACU to inpatient admission to the hospital is made |
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