Tolerance and Efficiency of Paracetamol Subcutaneous Inje... | NCT02884609

Studies
Tolerance and Efficiency of Paracetamol Subcutaneous Injection

NCT02884609

Sponsor

Centre Hospitalier Régional Metz-Thionville

Status

Completed

Last Update Posted

Apr 16, 2019Actual

Enrollment

160Actual

Phase

Not provided

Conditions

Pain

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Jul 2018Actual

Completion Date

Jul 2018Actual

First Submitted Date

Aug 26, 2016

First Submission Date that Met QC Criteria

Aug 26, 2016

First Posted Date

Aug 31, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2019

Last Update Posted Date

Apr 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of the severe or not adverse effects on the injection site		8 days

Secondary Outcomes

Measure	Description	Time Frame
as antipyretic, a feedback of tympanic temperature below 38°C during the two hours after injection		8 days
as analgesic, the decrease of pain (decrease of 30 in the numerical scale score, or a Algo+ scale score lower than 2/5)		8 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients hospitalized in palliative care service with an indication of Paracetamol by subcutaneous injection

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benoît LEHEUP, MD	CHR Metz-Thionville	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHR Metz-Thionville		Metz		57087	France
GH Diaconesses Croix Saint Simon

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29737243	Derived	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.

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms