PainPhase 2APAPSubQNCT03635684
Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen
A Phase 2 study testing Acetaminophen in people with Pain and Fever, run by Saint-Joseph University at 1 site in Lebanon.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Fever, Drug Effect
- What is being tested?
- Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteLebanon
- Study dates
- 17 May 2018to 1 Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen in Geriatrics and Palliative Care
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.
Read the detailed 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.
- Conditions
- Pain, Fever, Drug Effect, Drug Reaction
- Being tested
- Acetaminophen
- Keywords
- Acetaminophen, Palliative Care, Infusions, Subcutaneous, Treatment Outcome, Geriatrics, Gerontology
- Medical subject headings
- Pain, Fever, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Perfalgan, Paracetamol Macopharma
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.
| Study group | Role | What they receive |
|---|---|---|
| SC Acetaminophen | Experimental | Palliative Care or Geriatric Patients who receive subcutaneous Acetaminophen for pain or fever relief Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 60 minutes
Appearance of local side effects
Any local side effect is reported, including:
- edema,
- induration,
- erythema,
- tenderness,
- warmth,
- abcess,
- necrosis
Measured: 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
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.
Measured: 30 minutes
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.
Measured: 180 minutes
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.
Measured: 30 minutes
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.
Measured: 180 minutes
Early effect on fever
To evaluate if any early effect on fever is measurable, temperature is measured at t30 minutes.
Measured: 30 minutes
Sustained effect on fever
To evaluate if the effect on fever is sustained over time, temperature is measured at t180 minutes
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start17 May 2018
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe El Khoury, Saint-Joseph University
- Investigators
- Joe El Khoury, MD, Principal investigator, Hotel-Dieu de France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635684
- Sponsor's protocol ID
- APAPSC2018
- Acronym
- APAPSubQ
- Status last verified
- Jun 2020
- First submitted
- 18 May 2018
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen in Geriatrics and Palliative Care
- ClinicalTrials.gov ID
- NCT03635684
- Acronym / sponsor ID
- APAPSubQ / APAPSC2018
- Conditions
- Pain, Fever, Drug Effect, Drug Reaction
- Keywords
- Acetaminophen, Palliative Care, Infusions, Subcutaneous, Treatment Outcome, Geriatrics, Gerontology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 17 May 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SC Acetaminophen | Experimental | Drug: AcetaminophenPalliative Care or Geriatric Patients who receive subcutaneous Acetaminophen for pain or fever relief |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetaminophenAlso: Perfalgan, Paracetamol MacopharmaSubcutaneous 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. | Drug | SC Acetaminophen |
Primary outcome
Change in Numerical Rating Scale pain scores for conscious and cooperative patients
Time frame: 60 minutes
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.
Change on Algoplus Pain Scale for patients with verbal communication difficulties
Time frame: 60 minutes
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.
Change in temperature measurement
Time frame: 60 minutes
Decrease in temperature measurement. A Minimal Clinically Important Difference (MCID) of 0.5 degrees Celsius is set to define efficacy.
Appearance of local side effects
Time frame: at the time of perfusion, after 30 minutes, 60 minutes and 180 minutes, and one day after line removal
Any local side effect is reported, including: * edema, * induration, * erythema, * tenderness, * warmth, * abcess, * necrosis
6 secondary outcomes
Early effect on pain in conscious and cooperative patients
Time frame: 30 minutes
Sustained effect on pain in conscious and cooperative patients
Time frame: 180 minutes
Early effect on pain in patients with verbal communication difficulties
Time frame: 30 minutes
Sustained effect on pain in patients with verbal communication difficulties
Time frame: 180 minutes
Early effect on fever
Time frame: 30 minutes
Sustained effect on fever
Time frame: 180 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe El Khoury, MD principal investigator
Hotel-Dieu de France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetaminophen in people with Pain and Fever, run by Saint-Joseph University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numerical Rating Scale pain scores for conscious and cooperative patients (time frame: 60 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.