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Terminated Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00999245

Public ClinicalTrials.gov record NCT00999245. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 2:46 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00999245
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Carelon Research
Other
Enrollment
38 participants

Conditions and interventions

Eligibility (public fields only)

Age range
10 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2009
Primary completion
May 31, 2010
Completion
May 31, 2010
Last update posted
Apr 17, 2013

2010

United States locations

U.S. sites
28
U.S. states
16
U.S. cities
21
Facility City State ZIP Site status
Children's Hospital and Research Center Oakland California
Yale-New Haven Medical Center, New Haven Connecticut
A.I. duPont Hospital for Children Wilmington Delaware
Children's National Medical Center Washington D.C. District of Columbia
Howard University Hospital Washington D.C. District of Columbia
Emory University School of Medicine Atlanta Georgia
Medical College of Georgia Augusta Georgia
Children's Memorial Hospital Chicago Illinois
University of Illinois Sickle Cell Center Chicago Illinois
Kosair Children's Hospital Louisville Kentucky
Children's Hospital at Sinai Baltimore Maryland
Johns Hopkins Baltimore Maryland
National Institutes of Health Clinical Center Bethesda Maryland
Boston Medical Center Boston Massachusetts
Children's Hospital Boston Boston Massachusetts
University of Mississippi Medical Center Jackson Mississippi
Interfaith Medical Center Brooklyn New York
New York Methodist Hospital Brooklyn New York
The University of North Carolina at Chapel Hill Chapel Hill North Carolina
Duke University Medical Center Durham North Carolina
Cincinnati Children's Hospital Medical Center Cincinnati Ohio
Nationwide Children's Hospital Columbus Ohio
Ohio State University Columbus Ohio
Children's Hospital of Philadelphia Philadelphia Pennsylvania
St. Christopher's Hospital for Children Philadelphia Pennsylvania
Children's Hospital of Pittsburgh Pittsburgh Pennsylvania
Texas Children's Hospital Houston Texas
Virginia Commonwealth University Health Systems Richmond Virginia

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00999245, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 17, 2013 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00999245 live on ClinicalTrials.gov.

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