Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment

Pain Clinical Trial

Official title:

Procedural Pain in Palliative Care: Prevalence, Intensity and Treatment. A Prospective, Cross-sectional, Multicenter, National Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02437929
• Other study ID #: PCPP02
• Status: Completed
• Phase: N/A
• First received: April 30, 2015
• Last updated: July 11, 2016
• Start date: June 2015
• Est. completion date: April 2016

Study information

• Verified date: December 2015
• Source: Antea Associazione
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Observational

Clinical Trial Summary

This study aims to assess self reported procedural pain compared with background pain and evaluate pain intensity differences across six standard procedures. Besides, rescue and preventive treatments used to control procedural pain will be examined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1079
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients receiving the procedures included in this study as a part of their standard care

• Patients that have expressed their consent to participate to the study by signing the informed consent document

Exclusion Criteria:

• Very serious or unstable clinical conditions with a Karnofsky Performance Status Index (KPS) < 20

• Presence of neurological or psychiatric conditions, due to the original disease or concomitant diseases, interfering with the patient's level of consciousness or with judgment, such as to compromise compliance with the study protocol;

• Not adequately controlled background pain (average NRS in the last 24 hours is > 4)

• Emergency procedures or procedures performed during night time (from 8 p.m. until 8 a.m)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breakthrough Pain
• Cancer
• Pain
• Pain Due to Certain Specified Procedures
• Terminal Disease

Intervention

Procedure:
• Mobilization

• Positioning

• Personal Hygiene Care

• Bladder catheterization

• Wound care

• Subcutaneous drugs administration

Locations

Country	Name	City	State
Italy	San Marco hospice	Latina

Sponsors (1)

Lead Sponsor	Collaborator
Antea Associazione

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	11 Points - Numerical Rating Scale (NRS); change in baseline pain intensity during the procedure (of 3 points NRS or higher)	Self reported pain intensity 10 minutes before the procedure, during the procedure (measured immediately after that the procedure is performed), 10 minutes after the procedure. Each item is scored 0-10 (0 = no pain; 10 = worst possible pain).	Participants will be followed 10 minutes before the procedure, for the duration of the procedure and ten minutes after, an expected average of 1 hour	No