Oral Ibuprofene versus oral kethorolac for children with musculoskeletal injury: a double blind randomized controlled study.

INTERVENTION: 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 Concentration type: equal Concentration number: 40‐ Pharmaceutical form of the placebo: Oral suspension Route of administration of the placebo: Oral use Product Name: Ketorolac Product Code: [027253069] Pharmaceutical Form: Oral drops, solution INN or Proposed INN: Ketorolac Current Sponsor code: NA Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2‐ Pharmaceutical form of the placebo: Oral drops, solution Route of administration of the placebo: Oral use CONDITION: 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 Term: Pain of extremties System Organ Class: 100000004859 Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: 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. Primary end point(s): Pain reduction assessed on the NRS scale 60 minutes after the administration of the drug. 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). Timepoint(s) of evaluation of this end point: 60 minutes SECONDARY OUTCOME: 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 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