Sickle Cell Disease, Vaso-occlusive Crisis
Conditions
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. 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.
Interventions
PROCEDUREPatient controlled analgesia
Patients in this arm will be treated with a bolus of narcotic followed by PCA
DRUGnurse-administered intermittent IV bolus opioid therapy (NAIBOD)
In this arm patients will receive the current standard of care of IV bolus narcotic therapy
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
United States
Outcome results
None listed