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

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ClinicalTrials.gov Identifier: NCT04133623
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
IRCCS Burlo Garofolo

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 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.
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Pain reduction assessed on the NRS scale 60 minutes after the administration of the drug [ Time Frame: 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 :
  1. NRS 30 minutes after the administration of the drug [ Time Frame: 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.

  2. NRS at time 90 minutes after the administration of the drug [ Time Frame: 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.

  3. NRS at time 120 minutes after the administration of the drug [ Time Frame: 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.

  4. Patients who obtain a value of NRS <4 after 30 minutes from the administration of the drug. [ Time Frame: 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.

  5. Patients who obtain a value of NRS <4 after 60 minutes from the administration of the drug [ Time Frame: 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.

  6. Patients who obtain a value of NRS <4 after 90 minutes from the administration of the drug. [ Time Frame: 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.

  7. Patients who obtain a value of NRS <4 after 120 minutes from the administration of the drug. [ Time Frame: 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.

  8. Patients who obtain a reduction of NRS of more than 3 points after 30 minutes from the administration of the drug. [ Time Frame: NRS scale will be asked after 30 minutes from the administration of the drug. ]
    30 minutes after the administration of the drug.

  9. Patients who obtain a reduction of NRS of more than 3 points after 60 minutes from the administration of the drug. [ Time Frame: 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

  10. Patients who obtain a reduction of NRS of more than 3 points after 90 minutes from the administration of the drug. [ Time Frame: 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.

  11. Patients who obtain a reduction of NRS of more than 3 points after 120 minutes from the administration of the drug [ Time Frame: 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

  12. Adverse effects in the two groups [ Time Frame: 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).

  13. Emergency department outcome [ Time Frame: within 120 minutes from the administration of the drug ]

    Number of children that, following the emergency department visit, are:

    1. discharged at home
    2. temporary observed in the emergency department
    3. hospitalized



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133623


Contacts
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Contact: Cozzi Giorgio, MD PhD 040.3785.373 giorgio.cozzi@burlo.trieste.it
Contact: Ghirardo Sergio, MD PhD 040.3785.373 ghirardo.sergio@gmail.com

Locations
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Italy
Azienda Ospedaliera Santa Maria degli Angeli Not yet recruiting
Pordenone, Italy
Contact: Giuliana Morabito, MD         
Institute for Maternal and Child Health - IRCCS Burlo Garofolo- Not yet recruiting
Trieste, Italy, 34137
Contact: Cozzi Giorgio, MD PhD    +39040.3785.373    giorgio.cozzi@burlo.trieste.it   
Ospedale Santa Maria della Misericordia Not yet recruiting
Udine, Italy
Contact: Eva Passone, MD         
Sponsors and Collaborators
IRCCS Burlo Garofolo
Investigators
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Study Chair: Barbi Egidio, MD PhD Institute for Maternal and Child Health IRCCS Burlo Garofol

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Responsible Party: IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT04133623     History of Changes
Other Study ID Numbers: RC 21/18
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IRCCS Burlo Garofolo:
osteoarticular acute pain
ketorolac
ibuprofen
Additional relevant MeSH terms:
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Acute Pain
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Ibuprofen
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action