Status:
TERMINATED
THE IMPROVE TRIAL: Improving Pain Management and Outcomes With Various Strategies of Patient-Controlled Analgesia (PCA)
Lead Sponsor:
Carelon Research
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
10+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
The following things will be done for the study: 1. Each day you are in the hospital someone from the study team who does not know your treatment assignment will come in 3 times during the day to ask...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00999245
Start Date
January 1 2010
End Date
June 1 2010
Last Update
April 18 2013
Active Locations (28)
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1
Children's Hospital and Research Center
Oakland, California, United States
2
Yale-New Haven Medical Center,
New Haven, Connecticut, United States
3
A.I. duPont Hospital for Children
Wilmington, Delaware, United States
4
Children's National Medical Center
Washington D.C., District of Columbia, United States