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

• Status: Withdrawn
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Analgesics, Opioid; Narcotics

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 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