Usefulness of Acetaminophen Associated With Strong Opioids for Acute Pain in Cancer Patients

NCT04779567 | Completed Phase 4 DMC

• 1 other identifier: 180328004
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer pain is one of the most frequent and relevant symptoms in cancer patients and has a great impact on a patient's quality of life. International and local standards recommend as an initial strategy, the use of an analgesic scheme composed of strong opioids (morphine, methadone or fentanyl) associated with adjuvants such as paracetamol, based upon the assumption that the use of combined analgesics could have a better analgesic effect, could allow the use of lower dose of opioids and that also could prevent the occurrence of adverse effects of opioids. However, there is uncertainty about the impact of paracetamol as an adjuvant in patients who use strong opioids for pain management in cancer patients with moderate to severe pain. To clarify this question, this study aims to evaluate the efficacy and safety of intravenous paracetamol associated with strong opioids in hospitalized cancer patients who have pain associated with cancer of moderate to severe intensity, (4 or more), older than 18 years. Randomized double-blinded controlled study comparing intravenous acetaminophen 1 gr 4 times a day versus placebo for 48 hours as an adjuvant to strong opioids. We will assess pain intensity as a primary outcome validated assessments that estimate Verbal Numerical Rating Scale (VNRS) analogous verbal pain from 0 to 10, and de visual Analog Scale (VAS). We estimated that a decrease of 1 point on the verbal numerical scale would be statistically significant. In addition, the investigators will calculate the amount of total opioid dose in 24 hours and then perform the intervention. As a secondary outcome, adverse effects such as drowsiness, constipation, nausea and vomiting would be evaluated

Conditions

Acute Pain; Cancer Pain

Outcome Measures

Primary Outcomes (3)

• Efficacy of acetaminophen by Verbal Numerical Rating Scale (VNRS)

  The primary outcome of this study will be the difference in pain intensity between baseline (T=0) and 48 hours (T=2) using the Verbal Numerical Rating Scale (VNRS) reported by the patient to assess the effects of the intervention in pain intensity. We will compare the difference in pain intensity between the groups. The VNRS is a tool in which the patient is asked to score the mean intensity of pain during the last 24 hours in a scale from 0 to 10 with 0 meaning no pain at all and 10 meaning the worst possible pain.

  48 hours

• Efficacy of acetaminophen by Visual Analog scale (VAS), in a scale from 0 to 10 with 0 meaning no pain at all and 10 meaning the worst possible pain.

  The VAS uses a right triangle drawn on a paper, with a base of 10 cm wide and a height of 1cm on the right, in which its ends are delimited by a mark that expresses "without pain" on the left side and" worst pain I have ever felt" on the right side. The patient is asked to mark a vertical line crossing the horizontal line indicating the intensity of the pain. On the reverse, there is a superimposed line, with a graduation of 1 cm wide, which allows the data collector to identify the position in which the line marked by the patient is located. This indicates patients´ pain intensity score assigned by the patient on a scale from 0 to 10. We will also estimate the difference in pain intensity between baseline and 48 hours using the VAS and compare the magnitude of the difference between the arms.

  48 hours

• Efficacy of acetaminophen by total morphine equivalent daily dose (MEDD)

  MEDD at 48 hours. The MEDD represents the total dose of opioids used within the last 24 hours converted into an equivalent dose of parenteral morphine, following standard equianalgesic conversion tables

  48 Hours

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  T1: 24 hours and T2: 48 Hours

Study Arms (2)

Acetaminophen

EXPERIMENTAL

Acetaminophen 1 gr in 100 ml saline 0,9% iv 4 times a day

Drug: Acetaminophen

Placebo

PLACEBO COMPARATOR

100 ml saline 0.9% iv 4 times a day

Drug: Placebo

Interventions

Acetaminophen DRUG

Acetaminophen 1 gr iv 4 times a day

Acetaminophen

Placebo DRUG

100 ml saline 0.9% iv 4 times a day

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer patients hospitalized at UC Christus Clinical Hospital of any ethnicity or nationality.
• With acute pain\> or = a 4 in Verbal Numerical Rating Scale (VNRS)
• They can be patients who are virgins to opioids or previous users of weak or strong opioids.
• They may have somatic, visceral or neuropathic pain
• They may be users of NSAIDs or corticosteroids

You may not qualify if:

• Patients who refuse to enter the study
• Patients who don´t speak Spanish a mother language
• Patients who present a qualitative or quantitative awareness commitment that prevents the assessment of pain.
• Patients with acute liver failure or chronic liver damage Child C.
• Patients allergic or hypersensitive to paracetamol.
• Patients with a prognosis of life less than 72 hours (evaluated according to clinical criteria)

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Universidad Catolica de Chile

Santiago, 8330024, Chile

Location

Related Publications (36)

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Related Links

• Health Ministry
• Cancer pain relief. With a Guide to opioid availability
• Palliative care guideline

MeSH Terms

Conditions

Acute Pain; Cancer Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ofelia Leiva, MD

  Universidad Católica de Chile

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: matching placebo. prepared by pharmacist
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, Single center parallel-group, randomized double-blinded controlled study

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: March 3, 2021
• Study Start: June 10, 2019
• Primary Completion: June 11, 2021
• Study Completion: June 14, 2021
• Last Updated: August 13, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: We are unable to make the data available in a public repository or uploaded as supplementary information because this is not permitted by our organisation's research governance policy and Ethics committee regulations. Anonymised data can be made available to researchers who meet the conditions of the ethics approval and research governance policy that applies to this study. Researchers may request anonymized data access by contacting Universidad Católica's School of Medicine Research Office (DIDEMUC) at didemuc@med.puc.cl.

Locations

CL (1)