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Completed

NCT Number: NCT04133623

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

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)

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Key information

Conditions

Acute Pain Due to Trauma

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Azienda Ospedaliera Santa Maria degli Angeli, Pordenone, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac

Drug

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

Drug

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 outcomes

  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 outcomes

  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:

    • discharged at home
    • temporary observed in the emergency department
    • hospitalized

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

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

Acronym: IbuKet

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 21, 2019
Registry last updated
Jan 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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