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

Sponsor

Johns Hopkins University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00711698

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

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

Study Start Date :

Sep 1, 2007

Anticipated Primary Completion Date :

Sep 1, 2009

Anticipated Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Hospital	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator: Sophie Lanzkron, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT00711698

Other Study ID Numbers:

NA_00001163

First Posted:

Jul 9, 2008

Last Update Posted:

Mar 24, 2017

Last Verified:

Mar 1, 2017

Additional relevant MeSH terms:

Anemia, Sickle Cell

Analgesics, Opioid

Study Results

No Results Posted as of Mar 24, 2017