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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-19

Study Completion Date

2021-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Acute Pain Due to Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

double dummy

Study Groups

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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.

Group Type EXPERIMENTAL

Ketorolac

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No