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

Acute Pain Due to Trauma Clinical Trial

— IbuKet  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04133623
• Other study ID #: RC 21/18
• Status: Completed
• Phase: Phase 3
• Start date: November 19, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: January 2022
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Acute Pain Due to Trauma
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Santa Maria degli Angeli	Pordenone
Italy	Institute for Maternal and Child Health - IRCCS Burlo Garofolo-	Trieste
Italy	Ospedale Santa Maria della Misericordia	Udine

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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