Pain, Chronic, Pain, Discontinuation, Pain, Medication
Conditions
Brief summary
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
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.
Interventions
DRUGPlacebo
Patients who use regular paracetamol will now receive 6 to 8 tablets of placebo per day for 2 weeks
DRUGParacetamol
Patients who use regular paracetamol will now receive 6 to 8 tablets of 500 mg paracetamol per day for 2 weeks
Sponsors
University Hospital Bispebjerg and Frederiksberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale (VAS) pain during til last 24 hours | Change from baseline value at week 2 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment failure. | Week 2 | Number of participants that initiate other regular analgesics or withdraw from the trial |
| Grip strength | Change from baseline value at week 2 | Functional level is measured by grib strength with a Hand Dynamometer |
| Sitting-rising test | Change from baseline value at week 2 | Functional level is measured by a sitting-rising test |
| Sum of daily visual analog scale (VAS) pain | Sum from baseline to week 2 | 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 |
| EQ5D-5L index | Change from baseline value at week 2 | 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. |
| Followup: Visual analog scale (VAS) pain during til last 24 hours | Week 26 | 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 |
| Followup: EQ5D-5L index | Week 26 | 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. |
| Trial failure | Week 26 | Number of participants who initiated regular use of other analgesics and comparison of changes between the control and intervention group (post treatment period) |
| Followup: Number of regular users (3 grams of paracetamol or more per day) since ending treatment period. | week 26 | Did the intervention change the participants' paracetamol consumption after ending the treatment period. |
Countries
Denmark
Contacts
Primary ContactCharlotte Vermehren, PhD
Backup ContactLykke I Kaas Oldenburg
Outcome results
None listed