Current Industry and Federal Contracts

Improving Pain Management and Outcomes with Various Strategies of Patient-
Controlled Analgesia (PCA) (IMPROVE Trial)
Principal Investigator: Victor R. Gordeuk, MD
Clinical Coordinator: Sharmin Diaz and Kevin Cole

For more information on this study, Please visit the official ClinicalTrials.gov page.

Purpose:

Patient-Controlled Analgesia (PCA) means that the patient is in control of his/her pain medicine. In this study two (2) different treatment plans of Patient-Controlled Analgesia will be used to treat people with sickle cell disease who are admitted to the hospital for a pain crisis. The purpose of this study is to find out if one plan is better than the other in controlling sickle cell pain.

If you are eligible for the study, you will be assigned by chance (like flipping a coin) to either get a higher continuous amount of the pain medicine with a smaller amount for pain as you need it, OR to get a smaller continuous amount of pain medicine with a larger amount of pain medicine as you need it. You or your study doctor can not choose which plan you receive, and you will not be told which one you have been assigned to. The doctors and nurses taking care of you will know which plan you are assigned to so they can safely and effectively take care of your pain. Some members of the study team will not know which plan you are on.

We will give you morphine sulfate or hydromorphone (dilaudid) for your pain. These medicines are approved by the Food and Drug Administration (FDA) and have been used for a long time to relieve pain. If you have been treated for pain before with hydromorphone (dilaudid) and you prefer it to morphine, then you may choose to get it during the study. If you have not received hydromorphone (dilaudid) before or you do not have a preference then you will be given morphine for pain.

The pain medicine will be given through the IV in your arm. You will receive morphine or hydromorphone continuously through the IV and will also be able to use the PCA machine to give yourself extra pain medicine as you need it for pain. You will need to push a button to give yourself extra medicine for pain. The amount of pain medicine you get on these plans is based on how much you weigh.

Primary Objective:

To determine whether, in sickle cell patients 10 years or older hospitalized for severe vaso-occlusive pain, there is a difference in time to first occurrence of a large improvement in daily average pain intensity between a High Demand/Low Infusion (HDLI) dosing schedule vs. Low Demand/High Infusion (LDHI) dosing schedule for parenteral opioid.

Secondary Efficacy Objectives:

To compare the HDLI and LDHI treatment groups with respect to:

  1. Total volume of parenteral opioid delivered
  2. Other measures of opioid use during hospitalization
  3. Length of hospital stay (LOS)
  4. Activity and sleep parameters by actigraphy
  5. Activity levels and functional limitations, measured daily
  6. Global patient satisfaction
  7. Rates of patient requests for an alternative pain relief strategy or to exit the study.