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: 20.0 Level: LLT Classification code 10033472 T
Conditions
Interventions
Product Name: Ibuprofene
Product Code: [034102386]
Pharmaceutical Form: Oral suspension
INN or Proposed INN: ibuprofene
Current Sponsor code: NA
Concentration unit: mg/ml milligram(s)/millilitre
Conce
Sponsors
IRCCS MATERNO INFANTILE BURLO GAROFOLO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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; • Evaluation the number of patients requiring rescue painkillers in the two groups and the timing of their request; • 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Contacts
Public ContactUfficio Ricerca Clinica
IRCCS Burlo Garofolo
Outcome results
None listed