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

NCT00711698 | Withdrawn Phase 2

• 1 other identifier: NA_00001163
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Vaso-occlusive Crisis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

In this arm patients will be randomized to receive a bolus of narcotic followed by PCA.

Procedure: Patient controlled analgesia

2

ACTIVE COMPARATOR

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)

Interventions

Patient controlled analgesia PROCEDURE

Patients in this arm will be treated with a bolus of narcotic followed by PCA

1

nurse-administered intermittent IV bolus opioid therapy (NAIBOD) DRUG

In this arm patients will receive the current standard of care of IV bolus narcotic therapy

2

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented sickle cell disease
• Signed consent in outpatient clinic or during a prior hospitalization
• + 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Sophie Lanzkron, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 9, 2008
• Study Start: September 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 24, 2017

Record last verified: 2017-03

Locations

US (1)