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

Stopped early · Phase 3

Conditions studied: Sickle Cell Disease

In brief

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.

Key facts

Study ID: NCT00999245
Run by: Carelon Research
People needed: 38
Starts: 2010-01-01
Expected to finish: 2010-06-01
Last updated by the study team: 2013-04-18

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Sickle Cell Disease: Hemoglobin diagnosis of SS (two copies of the hemoglobin S gene), SC (one copy of the hemoglobin S gene and one copy of the hemoglobin C gene), SD (one copy of the hemoglobin S gene and one copy of the hemoglobin D gene), or S-β thalassemia (β+ or β0)
Male or female age ≥ 10 years.
Typical vaso-occlusive pain that is not adequately controlled in an ambulatory or acute care setting and which is expected to require > 24 hours of hospital care.
Pain Intensity Visual Analog (10 cm scale) score ≥ 4.5 cm, measured immediately after obtaining informed consent.
Adults willing and able to give informed consent; parents willing and able to give permission for study participation by their children; minor subjects (ages 10-17) willing and able to provide assent.
Ability to read/write English.

You may not qualify if…

Medical Indication
Presence of significant liver disease (ALT > 3 times institutional upper limit of normal, or direct bilirubin > 0.8 mg/dl within preceding 3 months)
Presence of significant renal dysfunction (within preceding 3 months, creatinine ≥ 1.2 mg/dl for ages >18 yrs, or ages 10-18 yrs creatinine ≥ 1.0 mg/dl)
Oxygen saturation by pulse oximetry ≤ 92% on room air at study entry
Any other medical condition that renders the subject unable to or unlikely to complete the study or which would interfere with optimal participation in the study or which poses significant risk to the subject from study treatment including but not limited to:
Concurrent acute chest syndrome
Right upper quadrant pain
Symptomatic sleep apnea
Brain injury or doses of opioids that preclude potential subjects' capacity to give informed consent.
Known (documented) hypersensitivity/intolerance to morphine and/or hydromorphone.
Clinically significant opioid tolerance in the opinion of the investigator that precludes safe and/or effective dosing or requires, under current management, receiving the following long-acting oral opioids:
Methadone 40 mg/day
Sustained/Extended release oral morphine 120 mg /day
Oxycodone 80 mg/day
Known pregnancy or currently breastfeeding.
Poor venous access that in the investigator's judgment would preclude maintaining an IV throughout the admission.
Currently participating in another research study.
Previously randomized in the IMPROVE trial.
Pain management in emergency department or Day Hospital ≥ 12 hours prior to decision to admit for inpatient care.
Subject or physician preference for treatment with opioids other than morphine or hydromorphone.

Where it is running

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

Full record on ClinicalTrials.gov

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