NCT04779567

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

Completed Phase 4 Last updated 13 August 2021

What this trial tests

Phase 4 trial testing Acetaminophen in Acute Pain in 112 participants. Completed in 14 June 2021.

Timeline

10 June 2019

Primary endpoint
11 June 2021

14 June 2021

Quick facts

Lead sponsor	Pontificia Universidad Catolica de Chile
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	112
Start date	10 June 2019
Primary completion	11 June 2021
Estimated completion	14 June 2021
Sites	1 location across Chile

Drugs / interventions tested

• Acetaminophen (Paracetamol) — full drug profile →
• Placebo

Conditions studied

• Acute Pain — all drugs for Acute Pain →
• Cancer Pain — all drugs for Cancer Pain →

Sponsor

Pontificia Universidad Catolica de Chile — full company profile →

Who can join

18 and older, any sex, with Acute Pain or Cancer Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Randomized double-blind controlled trial to assess the efficacy of intravenous acetaminophen associated with strong opioids in the treatment of acute pain in adult cancer patients: study protocol.
   Leiva O, Castellano J, Letelier LM, Rojas L, et al · · 2022 · cited 3× · PMID 35794673 · DOI 10.1186/s13063-022-06442-2