Paracetamol Discontinuation in the Elderly After Long-term Consumption (PARADISE)

University Hospital Bispebjerg and Frederiksberg

Status: Unknown

Conditions: Pain, Discontinuation; Pain, Chronic; Pain, Medication

Treatments: Drug: Placebo; Drug: Paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT04523740

2019-000203-33

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

98 participants in 2 patient groups

Placebo replacement

Experimental group

Description:

Participants will discontinue the paracetamol treatment, and be administered 6 to 8 tablets of placebo per day

Treatment:

Drug: Placebo

Usual care with paracetamol

Active Comparator group

Description:

Participants will continue the paracetamol treatment, and be administered 6 to 8 tablets of 500mg paracetamol per day

Treatment:

Drug: Paracetamol