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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This study has been withdrawn prior to enrollment.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)
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00711698
First received: July 7, 2008
Last updated: August 4, 2009
Last verified: August 2009
  Purpose

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: NAIBOD
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PCA for Pain Control in Adults With Sickle Cell Disease in the 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2007
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: NAIBOD
In this arm patients will receive the current standard of care of IV bolus narcotic therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711698

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

No publications provided

Responsible Party: Sophie Lanzkron, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00711698     History of Changes
Other Study ID Numbers: NA_00001163
Study First Received: July 7, 2008
Last Updated: August 4, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Narcotics
Analgesics
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014