Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579703
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Ketorolac for Acute Vaso-Occlusive Crisis in Pediatric Sickle Cell Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ketorolac Dosing for Acute Vaso-Occlusive Crisis in Pediatric Patients With Sickle Cell Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pediatric patients who present with acute vaso-occlusive pain crisis may have equivalent pain reduction scores at lower dosing of intravenous Ketorolac compared to standard dosing of 05 mgkgdose IV 16yo max 15mg 16yo max 30mg x 1 dose
Detailed Description:
Sickle Cell Disease is characterized by a point mutation that causes red cell polymerization and clinically results in pain events called vaso-occlusive crises VOC and end organ damage VOC is the most common reason for hospital admissions and ER visits in the SCD population Ketorolac is an NSAID class medication widely used for pain Ketorolac reversibly inhibits cyclooxygenase-1 and cyclooxygenase-2 and inhibits the formation of prostaglandins and thromboxane Specifically in the SCD pediatric population Ketorolac was shown to provide adequate pain relief without the need for additional IV analgesics in 50 of patients presenting to the emergency department with VOC Despite its potential benefits adverse effects from Ketorolac at standard dosing include gastrointestinal hemorrhage nephrotoxicity and drug-drug interactions some of which are dose-dependent Patients with SCD may be particularly vulnerable to acute kidney injury from nephrotoxic medications given the propensity for chronic kidney disease from ongoing anemia hemolysis and inflammation A retrospective review in hospitalized patients with SCD who received at least one dose of ketorolac found that higher doses of ketorolac was a risk factor for acute kidney injury In addition a case report on a pediatric patient with SCD showed irreversible renal failure and bleeding complications after administration of ketorolac despite adequate hydration The American Society of Hematology guidelines for management of acute and chronic pain in patients with sickle cell disease recommend a short course of NSAIDs in addition to opioids for acute pain management based on very low certainty of evidence
Several adult studies have suggested that the efficacy of ketorolac analgesia at 10mg is equivalent to higher doses 15mg-90mg for treatment of various pain syndromes in the ED setting post-operative and cancer pain However these studies excluded patients with SCD whose pain mechanism and pain thresholds may differ from these populations
The investigators propose a prospective randomized double blind clinical trial that will take place in the DCMC Emergency Department and Childrens Blood and Cancer Center Hematology Outpatient clinic
Several adult studies have suggested that the efficacy of ketorolac analgesia at 10mg is equivalent to higher doses 15mg-90mg for treatment of various pain syndromes in the ED setting post-operative and cancer pain However these studies excluded patients with SCD whose pain mechanism and pain thresholds may differ from these populations
The investigators propose a prospective randomized double blind clinical trial that will take place in the DCMC Emergency Department and Childrens Blood and Cancer Center Hematology Outpatient clinic
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