Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen

Pain Clinical Trial

— APAPSubQ  

Official title:

Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen in Geriatrics and Palliative Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03635684
• Other study ID #: APAPSC2018
• Status: Completed
• Phase: Phase 2
• Start date: May 17, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2020
• Source: Saint-Joseph University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Subcutaneous perfusion is an underused technique, the effectiveness of which has been demonstrated. It is mainly used in Palliative Care and Geriatrics when a venous line is not available. It is a simple and comfortable technique that allows to administer solutes and / or medications continuously or discontinuously in the subcutaneous tissue.

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. It is sometimes accused of causing pain at the injection site; it seems that this is not the case if it is infused slowly, over 20 minutes to 30 minutes. There is no report of serious local effects.

The consultation palliative care team at Hôtel-Dieu de France (HDF) has used subcutaneous Acetaminophen infusions repeatedly without adverse effects since January 2014.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Drug Effect
• Drug Reaction
• Drug-Related Side Effects and Adverse Reactions
• Fever
• Pain

Intervention

Drug:
• Acetaminophen
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.

Locations

Country	Name	City	State
Lebanon	Hotel-Dieu de France	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Early effect on pain in conscious and cooperative patients	To evaluate if any early effect on pain is measurable, this outcome measures the pain scores at t30 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.	30 minutes
Secondary	Sustained effect on pain in conscious and cooperative patients	To evaluate if the effect on pain is sustained over time, this outcome measures the pain scores at t180 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.	180 minutes
Secondary	Early effect on pain in patients with verbal communication difficulties	To evaluate if any early effect on pain is measurable, this outcome measures the pain scores at t60 minutes and t180 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.	30 minutes
Secondary	Sustained effect on pain in patients with verbal communication difficulties	To evaluate if the effect on pain is sustained over time, this outcome measures the pain scores at t180 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.	180 minutes
Secondary	Early effect on fever	To evaluate if any early effect on fever is measurable, temperature is measured at t30 minutes.	30 minutes
Secondary	Sustained effect on fever	To evaluate if the effect on fever is sustained over time, temperature is measured at t180 minutes	180 minutes