Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115336
Status:
TERMINATED
Last Update Posted:
2020-10-08
First Post:
2005-06-21
Brief Title:
Ketorolac Versus Ibuprofen to Treat Painful Episodes of Sickle Cell Disease
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Ketorolac Versus Ibuprofen for the Painful Crisis of Sickle Cell Disease - Southwestern Comprehensive Sickle Cell Center
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare ketorolac a potent non-steroidal anti-inflammatory drug NSAID with ibuprofen a commonly used NSAID for the treatment of the painful crisis of sickle cell disease SCD
Detailed Description:
BACKGROUND
SCD is a common disorder among African Americans and other minority groups It is characterized by chronic anemia and episodic vaso-occlusive crises The most common of these crises is the painful crisis Current treatment of the painful crisis includes rest hydration and analgesic medication Morphine is the most commonly prescribed analgesic medication for moderate to severe painful episodes but there are several side effects associated with its use including somnolence respiratory depression constipation dysphoria and pruritus Other analgesic medications including NSAIDs may improve pain control and decrease the need for morphine and other opioid drugs however more research is needed to confirm the benefits in individuals with SCD
DESIGN NARRATIVE
This study will enroll 120 children who will receive standard opioid and supportive therapy In addition to this care participants will be randomly assigned to receive one of the following 1 intravenous ketorolac and oral placebo or 2 intravenous placebo and oral ibuprofen Outcome assessments will include the duration of hospitalization for opioid therapy the degree of pain intensity and relief determined by validated pain scales and the utilization of opioid medications during hospitalization All participants will be monitored for potential adverse effects of the study medications by laboratory measurements and clinical assessments Additionally participants will self-report pain levels using the Oucher pain scale Participants will be monitored for the development of adverse events including gastrointestinal symptoms and deterioration of kidney function as determined by daily kidney function tests including BUN creatinine and hematuria
SCD is a common disorder among African Americans and other minority groups It is characterized by chronic anemia and episodic vaso-occlusive crises The most common of these crises is the painful crisis Current treatment of the painful crisis includes rest hydration and analgesic medication Morphine is the most commonly prescribed analgesic medication for moderate to severe painful episodes but there are several side effects associated with its use including somnolence respiratory depression constipation dysphoria and pruritus Other analgesic medications including NSAIDs may improve pain control and decrease the need for morphine and other opioid drugs however more research is needed to confirm the benefits in individuals with SCD
DESIGN NARRATIVE
This study will enroll 120 children who will receive standard opioid and supportive therapy In addition to this care participants will be randomly assigned to receive one of the following 1 intravenous ketorolac and oral placebo or 2 intravenous placebo and oral ibuprofen Outcome assessments will include the duration of hospitalization for opioid therapy the degree of pain intensity and relief determined by validated pain scales and the utilization of opioid medications during hospitalization All participants will be monitored for potential adverse effects of the study medications by laboratory measurements and clinical assessments Additionally participants will self-report pain levels using the Oucher pain scale Participants will be monitored for the development of adverse events including gastrointestinal symptoms and deterioration of kidney function as determined by daily kidney function tests including BUN creatinine and hematuria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U54HL070588 | NIH | None | httpsreporternihgovquickSearchU54HL070588 |