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

Johns Hopkins University

Status and phase: Withdrawn; Phase 2

Conditions: Vaso-occlusive Crisis; Sickle Cell Disease

Treatments: Procedure: Patient controlled analgesia; Drug: nurse-administered intermittent IV bolus opioid therapy (NAIBOD)

Study type: Interventional

Funder types: Other

Identifiers

NCT00711698

NA_00001163

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

Procedure: Patient controlled analgesia

2

Active Comparator group

Description:

In this arm patients will be randomized to the current standard of care of bolus narcotic treatment.

Treatment:

Drug: nurse-administered intermittent IV bolus opioid therapy (NAIBOD)