Comparison of Patient Controlled Analgesia (PCA) Versus Bolus Narcotic Therapy for the Treatment of Vaso-Occlusive Crisis (VOC)

Study Overview
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Brief Summary
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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.

Official Title
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PCA for Pain Control in Adults With Sickle Cell Disease in the Emergency Department (ED) Decreases Admission Rates Over Standard Bolus Therapy

Conditions
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Sickle Cell Disease, Vaso-occlusive Crisis

Intervention / Treatment
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* Procedure: Patient controlled analgesia
* Drug: nurse-administered intermittent IV bolus opioid therapy (NAIBOD)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>In this arm patients will be randomized to receive a bolus of narcotic followed by PCA. | Procedure: Patient controlled analgesia<br>* Patients in this arm will be treated with a bolus of narcotic followed by PCA<br>|
| Active Comparator: 2<br>In this arm patients will be randomized to the current standard of care of bolus narcotic treatment. | Drug: nurse-administered intermittent IV bolus opioid therapy (NAIBOD)<br>* In this arm patients will receive the current standard of care of IV bolus narcotic therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |