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NCT00999245 · ClinicalTrials.gov registry record · Phase 3
THE IMPROVE TRIAL: Improving Pain Management and Outcomes With Various Strategies of Patient-Controlled Analgesia (PCA)
A Phase 3 study, sponsored by Carelon Research.
- Terminated
- Registry status
- Phase 3
- Development phase
- 38
- Enrollment target
NCT00999245 is a Phase 3 study that was terminated before completion, run by Carelon Research. The registered enrollment target is 38 participants.
The verdict
NCT00999245, a Phase 3 study, was terminated before completion, sponsored by Carelon Research.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 38 participants
- Enrollment target
Study Summary
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.
Interventions
- OTHER High Demand / Low Infusion
- OTHER PCA Dosing Plan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2010-01 |
| Est. Completion | 2010-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00999245
The ClinicalTrials.gov registry entry for NCT00999245 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carelon Research, which has 50 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which High Demand / Low Infusion is the first listed.
NCT00999245 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00999245 about?
NCT00999245 is a clinical study titled "THE IMPROVE TRIAL: Improving Pain Management and Outcomes With Various Strategies of Patient-Controlled Analgesia (PCA)". 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 t...
What is the current status of trial NCT00999245?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 38 participants. The study started on 2010-01. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00999245?
The interventions under investigation include: High Demand / Low Infusion (OTHER), PCA Dosing Plan (OTHER).
Who is sponsoring clinical trial NCT00999245?
This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.
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