Back to resultsComparison of Patient Controlled Analgesia (PCA) Versus Bolus Narcotic Therapy for the Treatment of Vaso-Occlusive Crisis (VOC)
Primary Purpose
Sickle Cell Disease, Vaso-occlusive Crisis
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Patient controlled analgesia
nurse-administered intermittent IV bolus opioid therapy (NAIBOD)
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
In this arm patients will be randomized to receive a bolus of narcotic followed by PCA.
In this arm patients will be randomized to the current standard of care of bolus narcotic treatment.
Outcomes
Primary Outcome Measures
Decrease in admissions for those treated with a PCA in the ED v those that are given bolus narcotic dosing
Secondary Outcome Measures
Length of stay
Total narcotic used
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00711698
Brief Title
Comparison of Patient Controlled Analgesia (PCA) Versus Bolus Narcotic Therapy for the Treatment of Vaso-Occlusive Crisis (VOC)
Official Title
PCA for Pain Control in Adults With Sickle Cell Disease in the Emergency Department (ED) Decreases Admission Rates Over Standard Bolus Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
technical difficulties coordinating study
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
September 1, 2009 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Vaso-occlusive Crisis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
In this arm patients will be randomized to receive a bolus of narcotic followed by PCA.
Arm Title
2
Arm Type
Active Comparator
Arm Description
In this arm patients will be randomized to the current standard of care of bolus narcotic treatment.
Intervention Type
Procedure
Intervention Name(s)
Patient controlled analgesia
Intervention Description
Patients in this arm will be treated with a bolus of narcotic followed by PCA
Intervention Type
Drug
Intervention Name(s)
nurse-administered intermittent IV bolus opioid therapy (NAIBOD)
Intervention Description
In this arm patients will receive the current standard of care of IV bolus narcotic therapy
Primary Outcome Measure Information:
Title
Decrease in admissions for those treated with a PCA in the ED v those that are given bolus narcotic dosing
Time Frame
Measured at time of discharge from ED
Secondary Outcome Measure Information:
Title
Length of stay
Time Frame
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
Title
Total narcotic used
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Lanzkron, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Patient Controlled Analgesia (PCA) Versus Bolus Narcotic Therapy for the Treatment of Vaso-Occlusive Crisis (VOC)
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