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

ConditionsSickle Cell Disease Sickle Cell Crisis Veno-occlusive Disease

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age1-21

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

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients receiving NSAID medication <6 hours from presentation

known kidney injury

sickle nephropathy

bleeding concerns

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

102 Participants

are divided into 2 treatment groups

Group A: Reduced dose Ketorolac Arm AExperimental treatment 1 intervention

Group B: Standard of care dose Ketorolac Arm BActive comparator 1 intervention

Trial outcomes

Primary outcomes

FACES Pain Scale-Revised(FPS-R)

Has a range from 0 to 10 possible. 0 to 3 mild pain, 4 to 6 moderate pain, 7 to 10 severe pain.

Time frame

Assessed before dose of pain medication and 30 minutes post-dose

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: