Paracetamol Discontinuation in the Elderly After Long-term Consumption

Pain, Chronic Clinical Trial

— PARADISE  

Official title:

Paracetamol Discontinuation in the Elderly After Long-term Consumption

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04523740
• Other study ID #: 2019-000203-33
• Status: Recruiting
• Phase: N/A
• Start date: August 2020
• Est. completion date: December 2021

Study information

• Verified date: August 2020
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: Charlotte Vermehren, PhD
• Phone: +45 3863 5209
• Email: Charlotte.Vermehren[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic
• Pain, Discontinuation
• Pain, Medication

Intervention

Drug:
• Placebo
Patients who use regular paracetamol will now receive 6 to 8 tablets of placebo per day for 2 weeks
• Paracetamol
Patients who use regular paracetamol will now receive 6 to 8 tablets of 500 mg paracetamol per day for 2 weeks

Locations

Country	Name	City	State
Denmark	Department of clinical pharmacology	Copenhagen	Bispebjerg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Bispebjerg and Frederiksberg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Treatment failure.	Number of participants that initiate other regular analgesics or withdraw from the trial	Week 2
Secondary	Grip strength	Functional level is measured by grib strength with a Hand Dynamometer	Change from baseline value at week 2
Secondary	Sitting-rising test	Functional level is measured by a sitting-rising test	Change from baseline value at week 2
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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