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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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
- 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.
- 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
- Number of Participants With Complications and Adverse Events [ Time Frame: 30 days ]To describe adverse events, including infection, hypertension, and/or GI bleeding
- 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
- 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.
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
|United States, Texas|
|Texas Childrens Hospital|
|Houston, Texas, United States, 77030|