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

Ibuprofen Versus Ketorolac by Mouth in the Treatment of Acute Pain From Osteoarticular Trauma: a Randomized Double-blind Controlled Study.

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)

Study Overview

• Status: Completed
• Conditions: Acute Pain Due to Trauma
• Intervention / Treatment: Drug: Ketorolac; Drug: Ibuprofen

• Study Type: Interventional
• Enrollment (Actual): 212
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Pordenone, Italy
    • Azienda Ospedaliera Santa Maria Degli Angeli
  • Trieste, Italy, 34137
    • Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
  • Udine, Italy
    • Ospedale Santa Maria della Misericordia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketorolac; 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; 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.
Active Comparator: Ibuprofen; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS 30 minutes after the administration of the drug	NRS scale will be asked after 30 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.	30 minutes after the administration of the drug
NRS at time 90 minutes after the administration of the drug	NRS scale will be asked after 90 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.	90 minutes after the administration of the drug
NRS at time 120 minutes after the administration of the drug	NRS scale will be asked after 120 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.	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.	NRS scale will be asked after 30 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.	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	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.	60 minutes after the administration of the drug.
Patients who obtain a value of NRS <4 after 90 minutes from the administration of the drug.	NRS scale will be asked after 90 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.	90 minutes after the administration of the drug
Patients who obtain a value of NRS <4 after 120 minutes from the administration of the drug.	NRS scale will be asked after 120 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.	120 minutes after the administration of the drug.
Patients who obtain a reduction of NRS of more than 3 points after 30 minutes from the administration of the drug.	30 minutes after the administration of the drug.	NRS scale will be asked after 30 minutes from the administration of the drug.
Patients who obtain a reduction of NRS of more than 3 points after 60 minutes from 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	60 minutes after the administration of the drug.
Patients who obtain a reduction of NRS of more than 3 points after 90 minutes from the administration of the drug.	NRS scale will be asked after 90 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.	90 minutes after the administration of the drug.
Patients who obtain a reduction of NRS of more than 3 points after 120 minutes from the administration of the drug	NRS scale will be asked after 120 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	120 minutes after the administration of the drug.
Adverse effects in the two groups	By the medical or nursing staff patients will be evaluated after administration of the drug (headache, nausea, vomiting, somnolence, dyspepsia, abdominal pain, pruritus, dizziness and other reported symptoms).	within 120 minutes from the administration of the drug
Emergency department outcome	Number of children that, following the emergency department visit, are: discharged at home; temporary observed in the emergency department; hospitalized	within 120 minutes from the administration of the drug

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Chair: Barbi Egidio, MD PhD, Institute for Maternal and Child Health IRCCS Burlo Garofol

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2019
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): January 6, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: ibuprofen; ketorolac; osteoarticular acute pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac; Ibuprofen
• Other Study ID Numbers: RC 21/18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No