Tolerance and Efficiency of Paracetamol Subcutaneous Injection

NCT ID: NCT02884609

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2018-07-31

Brief Summary

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The purpose of this study is to evaluate the tolerance and the efficiency of subcutaneous administration of Paracetamol for patients in palliative care.

Detailed Description

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Subcutaneous administration is the most commonly used way for palliative care and geriatric service. A lot of drugs are recommended with subcutaneous administration, but their use is performed out of the Marketing Authorization, and fewer data exist about this practice in literature. Paracetamol is a grade 1 analgesic not currently recommended for subcutaneous injection, because of the lack of validated references. However this kind of administration is usually performed for Paracetamol in the French palliative care services related with its advantages for patients, as analgesic or antipyretic. The assumption of the study is that the use of paracetamol subcutaneously is possible with a good tolerance for hospitalized patients in palliative care service.

Conditions

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Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* older than 18 years old
* indication of paracetamol by subcutaneous injection, as an analgesic or an antipyretic

Exclusion Criteria

* opposition to gather data patient
* subcutaneous administration of paracetamol during the last week before the inclusion of the patient
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benoît LEHEUP, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Metz-Thionville

Locations

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CHR Metz-Thionville

Metz, , France

Site Status

GH Diaconesses Croix Saint Simon

Paris, , France

Site Status

Countries

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France

References

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Leheup BF, Ducousso S, Picard S, Alluin R, Goetz C. Subcutaneous administration of paracetamol-Good local tolerability in palliative care patients: An observational study. Palliat Med. 2018 Jul;32(7):1216-1221. doi: 10.1177/0269216318772472. Epub 2018 May 8.

Reference Type DERIVED
PMID: 29737243 (View on PubMed)

Other Identifiers

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2014-02Obs-CHRMT

Identifier Type: -

Identifier Source: org_study_id

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