Comparison between Ibuprofen by mouth and Ketorolac by mouth to offer relief from trauma pain.
- Conditions
- Pain is present in 78% of overall accesses in pediatric emergency rooms and, in most cases, it is acute and secondary to musculoskeletal trauma. Fifthy percent of patients report moderate to severe pain.It is difficult to assess the pain in children and the data are scarce about the most appropriate pain-killer therapy for pediatric patients. The most commonly used drugs are non-steroidal anti-inflammatory drugs and acetaminophen.MedDRA version: 20.0Level: LLTClassification code 10033472Term: Pain of extremtiesSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2018-004057-25-IT
- Lead Sponsor
- IRCCS MATERNO INFANTILE BURLO GAROFOLO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria: All the following requirements must be met:
•Present moderate-severe pain (value> = 4 on the NRS scale)
•Pain must be due to a trauma that has occurred in the last 48 hours
•Trauma must occur at limbs
•Age between 8 and 18 years: from the age of 8, until the completion of the eighteen years of age.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Will be excluded from the study every patient that met at list one of the following 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:
•or Intellectual disability (IQ & lt; 70)
•or 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Comparing the pain reduction (NRS score) of ketorolac and ibuprofen after 60 minutes from the administration of the drug for the treatment of acute pain from osteoarticular trauma.;Secondary Objective: • Comparing the pain reduction (NRS score) of ketorolac and ibuprofen after 30, 90 and 120 minutes from the administration of the drug for the treatment of acute pain from osteoarticular trauma;<br>• Evaluation the number of patients requiring rescue painkillers in the two groups and the timing of their request;<br>• Assessment of the appearance of adverse effects in the two groups (such as headache, nausea, vomiting, somnolence, dyspepsia, abdominal pain, pruritus, dizziness and other reported symptoms).;Primary end point(s): Pain reduction assessed on the NRS scale 60 minutes after the administration of the drug.;Timepoint(s) of evaluation of this end point: 60 minutes
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Assess incidence of adverse effects in the two groups (such as headache, nausea, vomiting, somnolence, dyspepsia, abdominal pain, pruritus, dizziness and other reported symptoms); Pain reduction assessed on the NRS scale at times 30, 90 and 120 minutes; Evaluate the number of patients requiring rescue painkillers in the two groups and the timing of their request;Timepoint(s) of evaluation of this end point: 1 day; 30-90-120 minutes; 1 day