An open label, pharmacokinetic and safety study of Combogesic® IV in pediatric patients with acute pain.

Conditions

Acute pain

Brief summary

The incidence of treatment-emergent adverse events associated with exposure to Combogesic® IV.

Detailed description

The time course of treatment-emergent adverse events, The incidence of treatment-related adverse events, The incidence of treatment-emergent adverse events of interest (cardiovascular, gastrointestinal, renal, hepatic, administration site conditions and bleeding-related events), Changes in vital sign measurements, Changes in clinical laboratory values, Patient’s global evaluation of the study drug, Define the pharmacokinetic parameters of Combogesic® IV including: Cmax, Tmax, t½, AUC(0-t), Extrapolated AUC(0-∞), Consumption of supplemental opioid medication in each 24-hour period as Morphine Milligram Equivalent (MME).

Related papers

No related papers found yet.

Interventions

DRUGParacetamol/Ibuprofen Vale 1000 mg/300 mg oldatos infúzió

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The incidence of treatment-emergent adverse events associated with exposure to Combogesic® IV.	—

Secondary

Measure	Time frame
The time course of treatment-emergent adverse events, The incidence of treatment-related adverse events, The incidence of treatment-emergent adverse events of interest (cardiovascular, gastrointestinal, renal, hepatic, administration site conditions and bleeding-related events), Changes in vital sign measurements, Changes in clinical laboratory values, Patient’s global evaluation of the study drug, Define the pharmacokinetic parameters of Combogesic® IV including: Cmax, Tmax, t½, AUC(0-t), Extrapolated AUC(0-∞), Consumption of supplemental opioid medication in each 24-hour period as Morphine Milligram Equivalent (MME).	—

Measure

Time frame

The time course of treatment-emergent adverse events, The incidence of treatment-related adverse events, The incidence of treatment-emergent adverse events of interest (cardiovascular, gastrointestinal, renal, hepatic, administration site conditions and bleeding-related events), Changes in vital sign measurements, Changes in clinical laboratory values, Patient’s global evaluation of the study drug, Define the pharmacokinetic parameters of Combogesic® IV including: Cmax, Tmax, t½, AUC(0-t), Extrapolated AUC(0-∞), Consumption of supplemental opioid medication in each 24-hour period as Morphine Milligram Equivalent (MME).

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Outcome results

None listed