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

IRCCS Burlo Garofolo

Status and phase: Completed; Phase 3

Conditions: Acute Pain Due to Trauma

Treatments: Drug: Ketorolac; Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT04133623

RC 21/18

Details and patient eligibility

About

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)

Enrollment: 212 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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212 participants in 2 patient groups

Ketorolac

Experimental group

Description:

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.

Treatment:

Drug: Ketorolac

Ibuprofen

Active Comparator group

Description:

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.

Treatment:

Drug: Ibuprofen