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

NCT04133623 | Completed Phase 3

• 1 other identifier: RC 21/18
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 3

Brief Summary

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)

Conditions

Acute Pain Due to Trauma

Keywords

osteoarticular acute pain; ketorolac; ibuprofen

Outcome Measures

Primary Outcomes (1)

• Pain reduction assessed on the NRS scale 60 minutes after the administration of the drug

  NRS scale will be asked after 60 minutes from the administration of the drug. To evaluate the NRS scale the patient is asked to express how much pain he feels through a number ranging from 0 to 10 in which 10 is the maximum pain. This is one of the most used methods in pain assessment. The difference will be calculated from the baseline.

  60 minutes after the administration of the drug

Secondary Outcomes (13)

• NRS 30 minutes after the administration of the drug

  30 minutes after the administration of the drug

• NRS at time 90 minutes after the administration of the drug

  90 minutes after the administration of the drug

• NRS at time 120 minutes after the administration of the drug

  120 minutes after the administration of the drug

• Patients who obtain a value of NRS <4 after 30 minutes from the administration of the drug.

  30 minutes after the administration of the drug

• Patients who obtain a value of NRS <4 after 60 minutes from the administration of the drug

  60 minutes after the administration of the drug.

Study Arms (2)

Ketorolac

EXPERIMENTAL

Administration of ketorolac 0.5 mg/kg up to 10 mg, one single dose at the enrollment. This group will receive also a placebo indistinguishable from the ibuprofen.

Drug: Ketorolac

Ibuprofen

ACTIVE COMPARATOR

Administration of ibuprofen 10 mg/kg up to 600 mg, one single dose at the enrollment. This group will receive also a placebo indistinguishable from the ketorolac.

Drug: Ibuprofen

Interventions

Ketorolac DRUG

Administration of ketorolac 0.5 mg/kg up to 10 mg, one single dose at the enrollment. This group will receive also a placebo indistinguishable from the ibuprofen.

Ketorolac

Ibuprofen DRUG

Administration of ibuprofen 10 mg/kg up to 600 mg, one single dose at the enrollment. This group will receive also a placebo indistinguishable from the ketorolac.

Ibuprofen

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 8 and 18 years
• Moderate to severe pain (value\>= 4 on the Numerical Rating scale / NRS)
• Pain due to a trauma at limbs that has occurred in the last 48 hours

You may not qualify if:

• Administration of any analgesic in the previous 8 hours.
• Allergy known to one of the active ingredients
• Known hepatopathy or nephropathy
• Suspicion of violence by others
• Chronic use of painkillers
• Inability to report pain due to the presence of: intellectual disability (IQ \<70); moderate-severe hearing loss; communication limitations such as patient mutism; unable to write; inability to speak Italian
• Chronic neurological or metabolic diseases,
• Positive history for ease of bleeding, coagulation disorder or
• thrombocytopenia
• A history of gastritis or esophagitis in the last 30 days
• Multiple trauma
• Vascular-vascular deficit
• State of pregnancy

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (3)

Azienda Ospedaliera Santa Maria degli Angeli

Pordenone, Italy

Location

Institute for Maternal and Child Health - IRCCS Burlo Garofolo-

Trieste, 34137, Italy

Location

Ospedale Santa Maria della Misericordia

Udine, Italy

Location

Related Publications (1)

• Ghirardo S, Trevisan M, Ronfani L, Zanon D, Maestro A, Barbieri F, De Nardi L, Amaddeo A, Barbi E, Cozzi G. Oral ibuprofen versus oral ketorolac for children with moderate and severe acute traumatic pain: a randomized comparative study. Eur J Pediatr. 2023 Feb;182(2):929-935. doi: 10.1007/s00431-022-04759-3. Epub 2022 Dec 17.

  PMID: 36526794 DERIVED

MeSH Terms

Interventions

Ketorolac; Ibuprofen

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Barbi Egidio, MD PhD

  Institute for Maternal and Child Health IRCCS Burlo Garofol

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double dummy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 21, 2019
• Study Start: November 19, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: January 6, 2022

Record last verified: 2022-01

Locations

IT (3)