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

Sickle Cell Disease Clinical Trial

Official title:

PCA for Pain Control in Adults With Sickle Cell Disease in the Emergency Department (ED) Decreases Admission Rates Over Standard Bolus Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00711698
• Other study ID #: NA_00001163
• Status: Withdrawn
• Phase: Phase 2
• First received: July 7, 2008
• Last updated: March 22, 2017
• Start date: September 2007
• Est. completion date: September 1, 2009

Study information

• Verified date: March 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease
• Vaso-occlusive Crisis

Intervention

Procedure:
• Patient controlled analgesia
Patients in this arm will be treated with a bolus of narcotic followed by PCA

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

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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