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

Phase 2

Withdrawn

• Conditions: Vaso-occlusive Crisis; Sickle Cell Disease
• Interventions: Procedure: Patient controlled analgesia; Drug: nurse-administered intermittent IV bolus opioid therapy (NAIBOD)

• Registration Number: NCT00711698
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-08
• Study First Posted: 2008-07-09
• Primary Completion: 2009-09
• Study Completion: 2009-09-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Patient controlled analgesia	In this arm patients will be randomized to receive a bolus of narcotic followed by PCA.
2	nurse-administered intermittent IV bolus opioid therapy (NAIBOD)	In this arm patients will be randomized to the current standard of care of bolus narcotic treatment.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States