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

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.

Study Overview

• Status: Unknown
• Conditions: Pain, Chronic; Pain, Medication; Pain, Discontinuation
• Intervention / Treatment: Drug: Placebo; Drug: Paracetamol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Bispebjerg
    • Copenhagen, Bispebjerg, Denmark, 2400
      • Recruiting
      • Department of Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg
• Investigators: Principal Investigator: Jon T Andersen, MD, PhD, Department of Clinical Pharmacology

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 21, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 2019-000203-33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No