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

Sponsor

IRCCS Burlo Garofolo (Other)

Overall Status

Completed

CT.gov ID

NCT04133623

Collaborator

(none)

212

Enrollment

Locations

Arms

22.4

Actual Duration (Months)

70.7

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Acute Pain Due to Trauma	Drug: Ketorolac Drug: Ibuprofen	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

212 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

double dummy

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 19, 2019

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

NRS 30 minutes after 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. 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.
NRS at time 90 minutes after the administration of the drug [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.
NRS at time 120 minutes after the administration of the drug [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.
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]
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.
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.]
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.
Patients who obtain a value of NRS <4 after 90 minutes from the administration of the drug. [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.
Patients who obtain a value of NRS <4 after 120 minutes from the administration of the drug. [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.
Patients who obtain a reduction of NRS of more than 3 points after 30 minutes from the administration of the drug. [NRS scale will be asked after 30 minutes from the administration of the drug.]
30 minutes after 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. [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
Patients who obtain a reduction of NRS of more than 3 points after 90 minutes from the administration of the drug. [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.
Patients who obtain a reduction of NRS of more than 3 points after 120 minutes from the administration of the drug [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
Adverse effects in the two groups [within 120 minutes from the administration of the drug]
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).
Emergency department outcome [within 120 minutes from the administration of the drug]
Number of children that, following the emergency department visit, are: discharged at home temporary observed in the emergency department hospitalized

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Azienda Ospedaliera Santa Maria degli Angeli	Pordenone	Italy
2	Institute for Maternal and Child Health - IRCCS Burlo Garofolo-	Trieste	Italy	34137
3	Ospedale Santa Maria della Misericordia	Udine	Italy