E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
Il dolore è presente nel 78% degli accessi complessivi in pronto soccorso pediatrico e, nella maggior parte dei casi, è acuto e secondario ad un trauma muscoloscheletrico; circa la metà dei pazienti riporta un dolore da moderato a grave. Risulta difficile valutare il dolore nel bambino e i dati sono scarsi su quale sia la terapia antidolorifica più adatta per i pazienti pediatrici, i farmaci più comunemente impiegati sono gli antinfiammatori non steroidei FANS e il paracetamolo. |
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E.1.1.1 | Medical condition in easily understood language |
Treatment in emergency department of acute musculoskeletal pain secondary to trauma in children |
Trattamento in pronto soccorso del dolore acuto da trauma muscolo scheletrico nei bambini |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033472 |
E.1.2 | Term | Pain of extremties |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Confrontare l’efficacia in termini di riduzione del dolore (punteggio NRS) di ketorolac e ibuprofene dopo 60 minuti dalla somministrazione del farmaco per il trattamento del dolore acuto da trauma osteoarticolare. |
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E.2.2 | Secondary objectives of the trial |
• 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). |
• Confrontare l’efficacia in termini di riduzione del dolore (punteggio NRS) di ketorolac e ibuprofene dopo 30, 90 e 120 minuti dalla somministrazione del farmaco per ill trattamento del dolore acuto da trauma osteoarticolare; • Valutare il numero di pazienti che richiedono l’antidolorifico rescue nei due gruppi e le tempistiche della sua richiesta; • Valutare la comparsa di effetti avversi nei due gruppi (quali cefalea, nausea, vomito, sonnolenza, dispepsia, dolore addominale, prurito, vertigini e altri sintomi segnalati). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
Tutti i seguenti requisiti dovranno essere soddisfatti: • Presentare un dolore moderato-grave (valore >=4 su scala NRS) • Il dolore deve essere riconducibile ad un trauma avvenuto nelle ultime 48 ore • Trauma agli arti • Età compresa tra 8 e 18 anni: dal compimento degli 8 anni, fino al compimento del diciottesimo anno di età. |
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E.4 | Principal 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 |
Il paziente verrà escluso qualora fossero presenti uno o più dei seguenti criteri: • Assunzione di qualsiasi analgesico nelle 8 ore precedenti. • Allergia nota ad uno dei principi attivi • Epatopatia o nefropatia note • Sospetto di violenza altrui • Uso cronico di antidolorifici • Incapacità di riferire il dolore per la presenza di: o Disabilità intellettiva (QI < 70) o Ipoacusia moderata-severa o Limitazioni comunicative quali mutismo in paziente o Incapace di scrivere. o Incapacità di parlare italiano • Malattie croniche neurologica o metabolica, • Anamnesi positiva per facilità di sanguinamento, disturbo della coagulazione o piastrinopenia • Anamnesi positiva per gastrite o esofagite negli ultimi 30 giorni • Trauma multiplo • Deficit vascolo-nervosi • Stato di gravidanza |
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E.5 End points |
E.5.1 | Primary end point(s) |
Pain reduction assessed on the NRS scale 60 minutes after the administration of the drug. |
Esito primario: • Riduzione del dolore valutato con scala NRS al tempo 60 minuti. Per valutare il dolore tramite scala NRS si chiede al paziente di esprimere quanto dolore prova al momento tramite un numero che va da 0 a 10 in cui 10 è il massimo del dolore. Questa è una delle metodiche più impiegate in letteratura per la valutazione del dolore. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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 |
• Valutare la comparsa di effetti avversi nei due gruppi (quali cefalea, nausea, vomito, sonnolenza, dispepsia, dolore addominale, prurito, vertigini e altri sintomi segnalati); • Riduzione del dolore valutato con scala NRS ai tempi 30, 90 e 120 minuti; • Valutare il numero di pazienti che richiedono l’antidolorifico rescue nei due gruppi e le tempistiche della sua richiesta; |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 day; 30-90-120 minutes; 1 day |
1 giorno; 30-90-120 minuti; 1 giorno |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
double dummy |
double dummy |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |