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Pilot study of the pharmacokinetic profile of paracetamol subcutaneously versus intravenously in patients in a palliative situation

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518795-31-00
Acronym
17-245
Enrollment
12
Registered
2024-10-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients (> 18 years of age) undergoing palliative care (defined by the WHO as active, comprehensive care given to patients whose condition does not respond to curative treatment) of their disease, able to communicate, and with a functional central venous line with reflux, presenting spontaneous pain with a numerical scale greater than 3 or paracetamol as part of their usual treatment.

Brief summary

- Measurement of paracetamolemia to determine AUC0-t, AUC0-, Cmax , Vd and t1/2 for each mode of administration for the same patient, and generation of pharmacokinetic curves.

Detailed description

- Pain assessment using a digital scale, - Skin monitoring and tolerance assessment throughout administration and protocol completion (D0 to D30), - Safety criterion: systematic collection of adverse events of any grade (CTCAE scale) from the signing of consent to D30 (minimum follow-up period for drug research).

Interventions

DRUGsolution pour perfusion

Sponsors

Centre Hospitalier Universitaire De Caen Normandie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
- Measurement of paracetamolemia to determine AUC0-t, AUC0-, Cmax , Vd and t1/2 for each mode of administration for the same patient, and generation of pharmacokinetic curves.

Secondary

MeasureTime frame
- Pain assessment using a digital scale, - Skin monitoring and tolerance assessment throughout administration and protocol completion (D0 to D30), - Safety criterion: systematic collection of adverse events of any grade (CTCAE scale) from the signing of consent to D30 (minimum follow-up period for drug research).

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026