Ketorolac for Acute Vaso-Occlusive Crisis in Pediatric Sickle Cell Disease

August 28, 2024 updated by: Children's Blood and Cancer Center at Dell Children's Medical Center

Ketorolac Dosing for Acute Vaso-Occlusive Crisis in Pediatric Patients With Sickle Cell Disease

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 0.5 mg/kg/dose IV (<16yo max 15mg, >16yo max 30mg) x 1 dose.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Children's Blood and Cancer Center Hematology Outpatient clinic.

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pediatric patients with sickle cell disease (any genotype) who present to DCMC Emergency department or outpatient hematology clinic with acute pain.

Exclusion Criteria:

  • Patients receiving NSAID medication <6 hours from presentation
  • known kidney injury
  • sickle nephropathy
  • bleeding concerns
  • allergy to NSAID medication
  • chronic pain patient
  • hemodynamic instability as defined by the treating provider

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reduced dose Ketorolac Arm A
a reduced dose of Ketorolac, 15 mg/mL
Drug: Ketorolac

Randomized to a single dose of:

Arm A: 15 mg/mL (per mL) Arm B: 30 mg/mL (per mL)

Other Names:
  • Toradol
Active Comparator: Standard of care dose Ketorolac Arm B
standard of care dose of Ketorolac, 30mg/mL
Drug: Ketorolac

Randomized to a single dose of:

Arm A: 15 mg/mL (per mL) Arm B: 30 mg/mL (per mL)

Other Names:
  • Toradol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FACES Pain Scale-Revised(FPS-R)
Time Frame: Assessed before dose of pain medication and 30 minutes post-dose
Has a range from 0 to 10 possible. 0 to 3 mild pain, 4 to 6 moderate pain, 7 to 10 severe pain.
Assessed before dose of pain medication and 30 minutes post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Blood and Cancer Center at Dell Children's Medical Center

Investigators

  • Principal Investigator: Alicia Chang, MD, Director, Comprehensive Sickle Cell Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

February 15, 2028

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

August 28, 2024

First Posted (Actual)

August 30, 2024

Study Record Updates

Last Update Posted (Actual)

August 30, 2024

Last Update Submitted That Met QC Criteria

August 28, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chang_pain in SCD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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