Clinical trial · Interventional
Usefulness of Acetaminophen Associated With Strong Opioids for Acute Pain in Cancer Patients
Randomized Double-blind Controlled Study to Assess the Efficacy of Intravenous Acetaminophen Associated With Strong Opioids in the Management of Acute Pain in Adult Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Pain | — | UNRESOLVED | — |
| Cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetaminophen | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Acetaminophen
- description
- Acetaminophen 1 gr in 100 ml saline 0,9% iv 4 times a day
- interventionNames
- Drug: Acetaminophen
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 100 ml saline 0.9% iv 4 times a day
- interventionNames
- Drug: Placebo
Primary outcomes (3)
- measure
- Efficacy of acetaminophen by Verbal Numerical Rating Scale (VNRS)
- timeFrame
- 48 hours
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (36)
- RESULTvan den Beuken-van Everdingen MHJ, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. High prevalence of pain in patients with cancer in a large population-based study in The Netherlands. Pain. 2007 Dec 5;132(3):312-320. doi: 10.1016/j.pain.2007.08.022. Epub 2007 Oct 3. PMID 17916403
- RESULTTeunissen SC, Wesker W, Kruitwagen C, de Haes HC, Voest EE, de Graeff A. Symptom prevalence in patients with incurable cancer: a systematic review. J Pain Symptom Manage. 2007 Jul;34(1):94-104. doi: 10.1016/j.jpainsymman.2006.10.015. Epub 2007 May 23. PMID 17509812
- RESULTGoudas LC, Bloch R, Gialeli-Goudas M, Lau J, Carr DB. The epidemiology of cancer pain. Cancer Invest. 2005;23(2):182-90. PMID 15813511
- RESULTPortenoy RK, Ahmed E. Principles of opioid use in cancer pain. J Clin Oncol. 2014 Jun 1;32(16):1662-70. doi: 10.1200/JCO.2013.52.5188. Epub 2014 May 5. PMID 24799466
- RESULTJimenez de la Jara J, Bastias G, Ferreccio C, Moscoso C, Sagues S, Cid C, Bronstein E, Herrera C, Nervi B, Corvalan A, Velasquez EV, Gonzalez P, Castellon E, Bustamante E, Onate S, McNerney E, Sullivan R, Owen GI. A snapshot of cancer in Chile: analytical frameworks for developing a cancer policy. Biol Res. 2015 Jan 26;48(1):10. doi: 10.1186/0717-6287-48-10. PMID 25761441
- RESULTHui D, Bruera E. A personalized approach to assessing and managing pain in patients with cancer. J Clin Oncol. 2014 Jun 1;32(16):1640-6. doi: 10.1200/JCO.2013.52.2508. Epub 2014 May 5. PMID 24799495
- RESULTJohnston M, Pollard B, Hennessey P. Construct validation of the hospital anxiety and depression scale with clinical populations. J Psychosom Res. 2000 Jun;48(6):579-84. doi: 10.1016/s0022-3999(00)00102-1. PMID 11033377