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Steroid Treatment for Sickle Cell Pain Crisis

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ClinicalTrials.gov Identifier: NCT00263562
Recruitment Status : Terminated (poor enrollment, availability of more effective medications)
First Posted : December 9, 2005
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Andrea Cruz, Baylor College of Medicine

Brief Summary:

The painful episode is the most common problem experienced by children with sickle cell disease. Although various treatments are available during painful episodes, the medication most commonly given for pain is a pain medication such as morphine. Fluids are also used. Even with these treatments, many children still have severe pain that is difficult to control. In addition to pain medications, there are other medications that may be useful. Methylprednisolone (solumedrol) and prednisone are a group of medications called steroids that may be helpful for painful episodes. These medications are known to lower the amount of inflammation (this means swelling, tenderness, and soreness) in the body. Because this medication may help with your pain, you are being asked to be a part of this study. These types of medications are used in other illnesses such as asthma, especially during times when the illness has gotten worse.

The main purpose of this study is to see if the methylprednisolone and prednisone will lower the amount of pain and the length of hospital stay.

In addition to the pain medication you will normally receive, you will be assigned to one of 2 groups: 1) the experimental group with the active form of the medicine, or 2) a comparison group without the active form of the medicine. In either group, you will still receive all of the treatments you would normally receive for a painful episode, including pain medicines and fluids. You and your doctors will not know what group you will be assigned.

If you decide to be a part of the study the following will happen:

For the first 5 days, you will be asked to: 1) describe your current pain (0=no pain to 10=a lot of pain), worst pain (0=no pain to 10=a lot of pain), least pain (0=no pain to 10=a lot of pain), and the amount of pain relief (0=no relief to 10=complete relief); 2) describe any signs or symptoms you feel, including filling out a pain scale form each day; 3) and take the medicines for 5 days, either at home or when in the hospital. Thirty days after the study, a study researcher will call and will ask questions about your pain, any painful episodes, and any medications you had. If you are discharged home sooner than 5 days after the start of the study, research staff will call you to ask you these questions, remind you to fill out your pain forms, and remind you to take your medicine. If you are discharged home, you will be given pain scales to fill out each day at home.


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Vaso-occlusive Crisis Drug: Steroid arm Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of High-dose Intravenous Methylprednisolone and Steroid Taper for Vaso-occlusive Crises in Sickle Cell Disease
Actual Study Start Date : December 1, 2005
Actual Primary Completion Date : June 13, 2008
Actual Study Completion Date : June 13, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Experimental: Steroid arm
Receipt of methyprednisolone pulse dose: 15mg/kg to a maximum of 1 gram; following this, the patients also received a steroid taper with oral prednisone:Day 2: Prednisone 2mg/kg PO BID Day 3: Prednisone 2mg/kg PO daily Day 4: Prednisone 1mg/kg PO daily Day 5: Prednisone 1mg/kg PO daily
Drug: Steroid arm
Day 1: Solumedrol 15 mg/kg (maximum 1 gram) Day 2: Prednisone 2mg/kg PO BID Day 3: Prednisone 2mg/kg PO daily Day 4: Prednisone 1mg/kg PO daily Day 5: Prednisone 1mg/kg PO daily
Other Name: Systemic corticosteroid receipt

Placebo Comparator: Comparison Group
Patients receiving usual care, with receipt of placebo (saline in lieu of intravenous methylprednisolone infusion or a number of placebo pills equivalent in number to what would have been received for the prednisone.
Other: Placebo
Patients received normal saline in lieu of intravenously-administered methylprednisolone and placebo pills equal in number to the steroid pills received in the steroid arm




Primary Outcome Measures :
  1. Pain Scores [ Time Frame: 30 days ]
    Severity of pain using a 10-point scale ranging from 1-10, with higher numbers corresponding to worsening pain.


Secondary Outcome Measures :
  1. Duration of Hospitalization [ Time Frame: Through hospitalization, up to 15 days ]
    Length of stay (from emergency department arrival to discharge from the inpatient unit), in days, through hospitalization, up to 15 days

  2. Number of Participants With Complications and Adverse Events [ Time Frame: 30 days ]
    To describe adverse events, including infection, hypertension, and/or GI bleeding

  3. Number of Participants With Recurrent Episodes of Pain Within 1 Month of Treatment [ Time Frame: 30 days ]
    Number of recurrent episodes of pain within 1 month of treatment

  4. Number of Days Analgesia Used [ Time Frame: Through hospitalization, up to 15 days ]
    # of days during which the child received parenterally-administered opioids through hospitalization, up to 15 days.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Sickle cell and acute pain Age 8 and up English or Spanish-speaking

Exclusion Criteria:

Fever greater than 101 Acute chest syndrome or pneumonia Other SS complications (sequestration, aplastic crisis) Other explanation for pain (chronic, AVN, surgical) History of GI bleeding, HTN, or hyperglycemia/DM


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263562


Locations
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United States, Texas
Texas Childrens Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
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Responsible Party: Andrea Cruz, Associate Professor, Pediatrics-Emergency Medicine, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00263562    
Other Study ID Numbers: H-17689
First Posted: December 9, 2005    Key Record Dates
Results First Posted: July 7, 2020
Last Update Posted: July 7, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Andrea Cruz, Baylor College of Medicine:
Sickle cell disease
vaso-occlusive crisis
steroid treatment
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn