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

NCT06579703 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2024-08-30

No results posted yet for this study

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

Conditions

Interventions

DRUG

Ketorolac

Randomized to a single dose of: Arm A: 15 mg/mL (per mL) Arm B: 30 mg/mL (per mL)

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Alicia Chang, MD · Director, Comprehensive Sickle Cell Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2027-07-01
Completion
2028-02-15
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06579703 on ClinicalTrials.gov