NCT04133623 (IbuKet) is a Phase 3 clinical trial of Ketorolac in Acute Pain Due to Trauma, sponsored by IRCCS Burlo Garofolo.

Who is sponsoring NCT04133623?

NCT04133623 is sponsored by IRCCS Burlo Garofolo.

What drugs are being tested in NCT04133623?

Interventions in NCT04133623: Ketorolac, Ibuprofen.

What condition does NCT04133623 study?

NCT04133623 studies Acute Pain Due to Trauma.

Is NCT04133623 still recruiting?

NCT04133623 is currently completed. Last updated 6 January 2022.

Last reviewed 2022-01-06 · How we verify

NCT04133623: IbuKet

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma

Completed Phase 3 Last updated 6 January 2022

What this trial tests

Phase 3 trial testing Ketorolac in Acute Pain Due to Trauma in 212 participants. Completed in 30 September 2021.

Timeline

19 November 2019

Primary endpoint
30 September 2021

30 September 2021

Quick facts

Lead sponsor	IRCCS Burlo Garofolo
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	212
Start date	19 November 2019
Primary completion	30 September 2021
Estimated completion	30 September 2021
Sites	3 locations across Italy

Drugs / interventions tested

Ketorolac (KETOROLAC) — full drug profile →
Ibuprofen (ibuprofen) — full drug profile →

Conditions studied

Acute Pain Due to Trauma — all drugs for Acute Pain Due to Trauma →

Sponsor

IRCCS Burlo Garofolo — full company profile →

Who can join

Adults 8 to 18, any sex, with Acute Pain Due to Trauma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pain is the leading cause of access to the paediatric emergency department (ED) and present in up to 78% of cases. Acute osteoarticular traumatic pain is often treated inadequately, and there is little data about the best treatment for children. The ibuprofen and ketorolac are respectively the most used and one of the most powerful NSAIDs. In literature, there is no direct comparison between those two medications. The objective of the study depends on the level of pain: * in severe traumatic acute pain (\>=7 points): to evaluate if ketorolac is superior to ibuprofen in the treatment of pain (n=130 children, 65 allocated to ketorolac and 65 to ibuprofen) * in moderate traumatic acute pain (\<7 points): to evaluate if ibuprofen is not inferior to ketorolac in the treatment of pain (n=120 children, 60 allocated to ketorolac and 60 to ibuprofen)

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Oral ibuprofen versus oral ketorolac for children with moderate and severe acute traumatic pain: a randomized comparative study.
Ghirardo S, Trevisan M, Ronfani L, Zanon D, et al · · 2023 · cited 7× · PMID 36526794 · DOI 10.1007/s00431-022-04759-3
Oral ibuprofen versus oral ketorolac for children with moderate and severe acute traumatic pain: a randomized comparative study
Ghirardo S, Trevisan M, Ronfani L, Zanon D, et al · · 2022 · DOI 10.21203/rs.3.rs-2005837/v1

Verify or expand the search:

Other trials of Ketorolac

Trials testing the same drug.

NCT07487246 — Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement · Phase 2 · not yet recruiting
NCT07430085 — Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA · Phase 4 · not yet recruiting
NCT06994442 — Optimizing Pain Treatment in Children On Mechanical Ventilation · Phase 3 · recruiting
NCT06968806 — Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection · Phase 3 · recruiting
NCT06973785 — Non-Narcotic Pain Control After ACL Reconstruction · Phase 3 · recruiting

Other IRCCS Burlo Garofolo trials

Trials by the same sponsor.

NCT06895278 — Articular Damage in Patients With Juvenile Idiopathic Arthritis After Transition to Adult Care · not yet recruiting
NCT05821569 — Cerebral Synchronization Between Mothers and Their Newborns During Breastfeeding · unknown
NCT06310421 — Spinal Muscular Atrophy Neonatal Screening Program · recruiting
NCT05806372 — Biomarkers of CVD Dysfunction in Hypertensive Disorders of Pregnancy · unknown
NCT06324578 — Prevalence of Pre-clinical Sjögren Disease and Other Immune Disturbances in Subjects With Autoimmune Thyroiditis Disease · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04133623 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by IRCCS Burlo Garofolo
Last refreshed: 6 January 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04133623.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing