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Clinical trialNCT00999245TerminatedPhase 3Interventional

THE IMPROVE TRIAL: Improving Pain Management and Outcomes With Various Strategies of Patient-Controlled Analgesia (PCA)

SponsorCarelon ResearchEnrollment38Sickle Cell Disease
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

28 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Children'S Hospital and Research Center

    Oakland, California, United States

  • Yale-New Haven Medical Center,

    New Haven, Connecticut, United States

  • A.I. Dupont Hospital for Children

    Wilmington, Delaware, United States

  • Children'S National Medical Center

    Washington D.C., District of Columbia, United States

  • Howard University Hospital

    Washington D.C., District of Columbia, United States

  • Emory University School of Medicine

    Atlanta, Georgia, United States

  • Medical College of Georgia

    Augusta, Georgia, United States

  • Children'S Memorial Hospital

    Chicago, Illinois, United States

  • University of Illinois Sickle Cell Center

    Chicago, Illinois, United States

  • Kosair Children'S Hospital

    Louisville, Kentucky, United States

  • Children'S Hospital at Sinai

    Baltimore, Maryland, United States

  • Johns Hopkins

    Baltimore, Maryland, United States

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, United States

  • Boston Medical Center

    Boston, Massachusetts, United States

  • Children'S Hospital Boston

    Boston, Massachusetts, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, United States

  • Interfaith Medical Center

    Brooklyn, New York, United States

  • New York Methodist Hospital

    Brooklyn, New York, United States

  • the University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, United States

  • Duke University Medical Center

    Durham, North Carolina, United States

  • Cincinnati Children'S Hospital Medical Center

    Cincinnati, Ohio, United States

  • Nationwide Children'S Hospital

    Columbus, Ohio, United States

  • Ohio State University

    Columbus, Ohio, United States

  • Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

  • St. Christopher'S Hospital for Children

    Philadelphia, Pennsylvania, United States

  • Children'S Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, United States

  • Texas Children'S Hospital

    Houston, Texas, United States

  • Virginia Commonwealth University Health Systems

    Richmond, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jan 2010
Primary completion
30 Jun 2010
Completion
30 Jun 2010
Last update posted
18 Apr 2013
Registered enrollment
38
Registry id
NCT00999245

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.