Usefulness of Acetaminophen Associated With Strong Opioids for Acute Pain in Cancer Patients
Status:
Completed
Trial end date:
2021-06-14
Target enrollment:
Participant gender:
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