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

NCT06579703 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: Chang_pain in SCD
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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

Conditions

Sickle Cell Disease; Sickle Cell Crisis; Veno-occlusive Disease

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (2)

Reduced dose Ketorolac Arm A

EXPERIMENTAL

a reduced dose of Ketorolac, 15 mg/mL

Drug: Ketorolac

Standard of care dose Ketorolac Arm B

ACTIVE COMPARATOR

standard of care dose of Ketorolac, 30mg/mL

Drug: Ketorolac

Interventions

Ketorolac DRUG

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

Also known as: Toradol

Reduced dose Ketorolac Arm A; Standard of care dose Ketorolac Arm B

Eligibility Criteria

• Age: 1 Day - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Related Publications (9)

• Brandow AM, Carroll CP, Creary S, Edwards-Elliott R, Glassberg J, Hurley RW, Kutlar A, Seisa M, Stinson J, Strouse JJ, Yusuf F, Zempsky W, Lang E. American Society of Hematology 2020 guidelines for sickle cell disease: management of acute and chronic pain. Blood Adv. 2020 Jun 23;4(12):2656-2701. doi: 10.1182/bloodadvances.2020001851.

  PMID: 32559294 BACKGROUND

• Shapiro BS. The management of pain in sickle cell disease. Pediatr Clin North Am. 1989 Aug;36(4):1029-45. doi: 10.1016/s0031-3955(16)36735-9.

  PMID: 2666928 RESULT

• Jones SF, O'Donnell AM. Clinical pharmacology: traditional NSAIDs and Jones SF, O'Donnell AM. Clinical pharmacology: traditional NSAIDs and selective COX-2 inhibitors. In: Macintyre PE, Walker SM, Rowbotham DJ, et al, eds. Clinical Pain Management (Acute Pain). 2nd ed. London, England: Hodder & Stoughton Limited; 2008:79.

  RESULT

• Motov S, Yasavolian M, Likourezos A, Pushkar I, Hossain R, Drapkin J, Cohen V, Filk N, Smith A, Huang F, Rockoff B, Homel P, Fromm C. Comparison of Intravenous Ketorolac at Three Single-Dose Regimens for Treating Acute Pain in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2017 Aug;70(2):177-184. doi: 10.1016/j.annemergmed.2016.10.014. Epub 2016 Dec 16.

  PMID: 27993418 RESULT

• Staquet MJ. A double-blind study with placebo control of intramuscular ketorolac tromethamine in the treatment of cancer pain. J Clin Pharmacol. 1989 Nov;29(11):1031-6. doi: 10.1002/j.1552-4604.1989.tb03274.x.

  PMID: 2689472 RESULT

• Minotti V, Betti M, Ciccarese G, Fumi G, Tonato M, Del Favero A. A double-blind study comparing two single-dose regimens of ketorolac with diclofenac in pain due to cancer. Pharmacotherapy. 1998 May-Jun;18(3):504-8.

  PMID: 9620101 RESULT

• Brown CR, Moodie JE, Wild VM, Bynum LJ. Comparison of intravenous ketorolac tromethamine and morphine sulfate in the treatment of postoperative pain. Pharmacotherapy. 1990;10(6 ( Pt 2)):116S-121S.

  PMID: 2082307 RESULT

• Simckes AM, Chen SS, Osorio AV, Garola RE, Woods GM. Ketorolac-induced irreversible renal failure in sickle cell disease: a case report. Pediatr Nephrol. 1999 Jan;13(1):63-7. doi: 10.1007/s004670050565.

  PMID: 10100293 RESULT

• Baddam S, Aban I, Hilliard L, Howard T, Askenazi D, Lebensburger JD. Acute kidney injury during a pediatric sickle cell vaso-occlusive pain crisis. Pediatr Nephrol. 2017 Aug;32(8):1451-1456. doi: 10.1007/s00467-017-3623-6. Epub 2017 Feb 25.

  PMID: 28238158 RESULT

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises

Interventions

Ketorolac; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Alicia Chang, MD

  Director, Comprehensive Sickle Cell Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rhea Robinson, RN, BSN

CONTACT

512-628-1902; Rmrobinson@ascension.org

Ashley Sherrod, RN, BSN

CONTACT

512-628-1902; APSherrod@ascension.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator, subject, bedside nurse and provider assessing at the bedside will be blinded. There will be an unblinded personnel for dose preparation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized to 1 of 2 arms, parallel dosing

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 30, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): February 15, 2028
• Last Updated: August 30, 2024

Record last verified: 2024-08