Clinical trial NCT04523740: Paracetamol Discontinuation in the Elderly After Long-term Consumption
Official title: Paracetamol Discontinuation in the Elderly After Long-term Consumption
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Chronic
Pain, Medication
Pain, Discontinuation
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 98
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual analog scale (VAS) pain during til last 24 hours
timeFrame: Change from baseline value at week 2
Secondary outcomes:
measure: EQ5D-5L index
timeFrame: Change from baseline value at week 2
measure: Treatment failure.
timeFrame: Week 2
measure: Grip strength
timeFrame: Change from baseline value at week 2
measure: Sitting-rising test
timeFrame: Change from baseline value at week 2
measure: Sum of daily visual analog scale (VAS) pain
timeFrame: Sum from baseline to week 2
measure: Followup: Number of regular users (3 grams of paracetamol or more per day) since ending treatment period.
timeFrame: week 26
measure: Followup: Visual analog scale (VAS) pain during til last 24 hours
timeFrame: Week 26
measure: Followup: EQ5D-5L index
timeFrame: Week 26
measure: Trial failure
timeFrame: Week 26
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of clinical pharmacology
state: Bispebjerg
Study officials:
affiliation: Department of Clinical Pharmacology
name: Jon T Andersen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: