Paracetamol Discontinuation in the Elderly After Long-term Consumption

Study Overview
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Brief Summary
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To investigate if long-term treatment of paracetamol can be discontinued without no worsening on pain, health-related quality-of-life and level of function compared to continuing paracetamol treatment in patients aged 65 years or more.

Detailed Description
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Aim: To investigate if long-term treatment of paracetamol can be discontinued without worsening on pain, health-related quality-of-life and level of function compared to continuing paracetamol treatment in patients aged 65 years or more. Trial design: Patients are randomized to either arm 1: standard care (paracetamol continuation) or arm 2: experimental treatment (placebo). The investigation is double-blinded. Patients are screened and recruited from Department of respiratory medicine at Copenhagen University Hospital Bispebjerg. Patients with a daily consumption of 3 grams or more of prescribed paracetamol and who comply with the other eligibility criteria will be invited to participate in the trial and asked for written, informed consent. If given we collect data regarding the patient's medications, any medication changes during the intervention and followup, frailty (FRAIL Scale), self-reported history of falls, recent admissions, self-reported health-related quality of life (EQ-5D-5L), level of function tested by hand grib strength and sitting-rising test, and death. Data is collected at baseline and after 2 weeks when ending treatment intervention, and a 26 week follow-up.

Official Title
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Paracetamol Discontinuation in the Elderly After Long-term Consumption

Conditions
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Pain, Chronic, Pain, Medication, Pain, Discontinuation

Intervention / Treatment
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* Drug: Placebo
* Drug: Paracetamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 65 years or more Regular daily users of 3 to 4 grams of paracetamol for at least 6 months prior to enrollment Exclusion Criteria: Malignant pain cf. their medical records Patients using other regular analgesics cf. indication on prescription Patients receiving paracetamol tablets with modified release or sustained release Patients in warfarin treatment Patients with terminal illnesses, cf. their medical records. Patients receiving dosages dispensed by their pharmacy Mini-Mental State Examination (MMSE) score less than 25 Patients with or suspected to have COVID-19.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo replacement<br>Participants will discontinue the paracetamol treatment, and be administered 6 to 8 tablets of placebo per day | Drug: Placebo<br>* Patients who use regular paracetamol will now receive 6 to 8 tablets of placebo per day for 2 weeks<br>|
| Active Comparator: Usual care with paracetamol<br>Participants will continue the paracetamol treatment, and be administered 6 to 8 tablets of 500mg paracetamol per day | Drug: Paracetamol<br>* Patients who use regular paracetamol will now receive 6 to 8 tablets of 500 mg paracetamol per day for 2 weeks<br>* Other names: Acetaminophen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) pain during til last 24 hours | Comparison of changes in visual analog scale (VAS) pain intensity during the last 24 hours, from baseline value at week 2 between the control and intervention group. VAS is a 0-100 mm scale where 0 is no pain and 100 is worst pain | Change from baseline value at week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ5D-5L index | Comparison of changes in EQ5D-5L index from baseline values at week 2 between the control and intervention group. EQ-5D is an abbreviation for European Quality of life - 5 Dimensions and measures Quality of Life. The scale has five subcomponents with scores from 1 (best) to 5 (worst). The five subcomponents constitute a health state that is translated into an index value using the Danish Crosswalk Index Value Calculator from Euroqol's website. The index value is anchored at 0 = death and 1 = full health and the range in the Danish population is from -0.624 (worse than death) to 1.0 (full health). Higher values / increases in index value is better than lower values / decreases in index value. | Change from baseline value at week 2 | 
| Treatment failure. | Number of participants that initiate other regular analgesics or withdraw from the trial | Week 2 | 
| Grip strength | Functional level is measured by grib strength with a Hand Dynamometer | Change from baseline value at week 2 | 
| Sitting-rising test | Functional level is measured by a sitting-rising test | Change from baseline value at week 2 | 
| Sum of daily visual analog scale (VAS) pain | Collected from a trial diary. Visual analog scale (VAS) is a 0-100 mm scale where 0 is no pain and 100 is worst pain | Sum from baseline to week 2 | 
| Followup: Number of regular users (3 grams of paracetamol or more per day) since ending treatment period. | Did the intervention change the participants' paracetamol consumption after ending the treatment period. | week 26 | 
| Followup: Visual analog scale (VAS) pain during til last 24 hours | Comparison of changes from baseline and week 2 values at week 26 (post treatment period). Visual analog scale (VAS) is a 0-100 mm scale where 0 is no pain and 100 is worst pain | Week 26 | 
| Followup: EQ5D-5L index | Comparison of changes in EQ5D-5L index from baseline and week 2 values at week 26 (post treatment period) between the control and intervention group. EQ-5D is an abbreviation for European Quality of life - 5 Dimensions and measures Quality of Life. The scale has five subcomponents with scores from 1 (best) to 5 (worst). The five subcomponents constitute a health state that is translated into an index value using the Danish Crosswalk Index Value Calculator from Euroqol's website. The index value is anchored at 0 = death and 1 = full health and the range in the Danish population is from -0.624 (worse than death) to 1.0 (full health). Higher values / increases in index value is better than lower values / decreases in index value. | Week 26 | 
| Trial failure | Number of participants who initiated regular use of other analgesics and comparison of changes between the control and intervention group (post treatment period) | Week 26 |