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

This study has been withdrawn prior to enrollment.
(technical difficulties coordinating study)
Information provided by (Responsible Party):
Johns Hopkins University Identifier:
First received: July 7, 2008
Last updated: March 22, 2017
Last verified: March 2017
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.

Condition Intervention Phase
Sickle Cell Disease
Vaso-occlusive Crisis
Procedure: Patient controlled analgesia
Drug: nurse-administered intermittent IV bolus opioid therapy (NAIBOD)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: PCA for Pain Control in Adults With Sickle Cell Disease in the Emergency Department (ED) Decreases Admission Rates Over Standard Bolus Therapy

Resource links provided by NLM:

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]
  • 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 ]

Enrollment: 0
Study Start Date: September 2007
Estimated Study Completion Date: September 1, 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
In this arm patients will be randomized to receive a bolus of narcotic followed by PCA.
Procedure: Patient controlled analgesia
Patients in this arm will be treated with a bolus of narcotic followed by PCA
Active Comparator: 2
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)
In this arm patients will receive the current standard of care of IV bolus narcotic therapy


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT00711698

United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Sophie Lanzkron, MD Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University Identifier: NCT00711698     History of Changes
Other Study ID Numbers: NA_00001163
Study First Received: July 7, 2008
Last Updated: March 22, 2017

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on April 28, 2017