Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen

NCT03635684 | Completed Phase 2

• 1 other identifier: APAPSC2018
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Subcutaneous perfusion is an underused technique, the effectiveness of which has been demonstrated. A number of drugs of different therapeutic classes, including morphine, have a good level of scientific evidence for use by this route. Subcutaneous Acetaminophen injection is being used in some medical centers, mainly in Europe, despite the lack of definite evidence on its efficacy. This study aims to quantify the degree of effectiveness of subcutaneous Acetaminophen infusions for pain or fever in Geriatrics and Palliative Care, as well as determining its safety.

Conditions

Pain; Fever; Drug Effect; Drug Reaction

Keywords

Acetaminophen; Palliative Care; Infusions, Subcutaneous; Treatment Outcome; Geriatrics; Gerontology

Outcome Measures

Primary Outcomes (4)

• Change in Numerical Rating Scale pain scores for conscious and cooperative patients

  This outcome measures the decrease in pain scores between t0 (right before acetaminophen administration) and t60 minutes using the Numerical Rating Scale in conscious and cooperative patients, where 10/10 is the worst imaginable pain and 0/10 is no pain at all. A Minimal Clinically Important Difference (MCID) of 2/10 is set to define efficacy.

  60 minutes

• Change on Algoplus Pain Scale for patients with verbal communication difficulties

  This outcome measures the decrease in pain scores between t0 (right before acetaminophen administration) and t60 minutes using Algoplus Scale, a behavioural rating scale for acute pain for patients with verbal communication difficulties. A score of 2 or above diagnoses pain with 87% sensitivity and 80% specificity. The scale evaluates facial expressions, look, complaints, body position and atypical behaviours of patients with verbal communication difficulties. Each item marked "yes" is awarded one point and the total across all the items gives a total score out of 5. Efficacy is defined as a decrease of the score to less than 2/5.

  60 minutes

• Change in temperature measurement

  Decrease in temperature measurement. A Minimal Clinically Important Difference (MCID) of 0.5 degrees Celsius is set to define efficacy.

  60 minutes

• Appearance of local side effects

  Any local side effect is reported, including: * edema, * induration, * erythema, * tenderness, * warmth, * abcess, * necrosis

  at the time of perfusion, after 30 minutes, 60 minutes and 180 minutes, and one day after line removal

Secondary Outcomes (6)

• Early effect on pain in conscious and cooperative patients

  30 minutes

• Sustained effect on pain in conscious and cooperative patients

  180 minutes

• Early effect on pain in patients with verbal communication difficulties

  30 minutes

• Sustained effect on pain in patients with verbal communication difficulties

  180 minutes

• Early effect on fever

  30 minutes

Study Arms (1)

SC Acetaminophen

EXPERIMENTAL

Palliative Care or Geriatric Patients who receive subcutaneous Acetaminophen for pain or fever relief

Drug: Acetaminophen

Interventions

Acetaminophen DRUG

Subcutaneous infusion of Acetaminophen over 20 to 30 minutes, with evaluation of: * local side effects; * pain and/or fever; at time of infusion, after 30 minutes, 60 minutes and 180 minutes.

Also known as: Perfalgan, Paracetamol Macopharma

SC Acetaminophen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients seen by the Palliative Care Consultation Team, patients admitted in the Palliative Care Unit, or Geriatric patients (patients aged 65 and older) in participating centers in Lebanon
• Presence of pain or fever necessitating the administration of Paracetamol
• Absence of an Intravenous Line

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Hotel-Dieu de France

Beirut, Lebanon

Location

MeSH Terms

Conditions

Pain; Fever; Drug-Related Side Effects and Adverse Reactions

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Joe El Khoury, MD

  Hotel-Dieu de France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: August 17, 2018
• Study Start: May 17, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)