Randomized double-blind controlled trial to assess the efcacy of intravenous acetaminophen associated with strong opioids in the treatment of acute pain in adult cancer patients: study protocol

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dc.article.number548
dc.contributor.authorLeiva, Ofelia
dc.contributor.authorCastellano, Joel
dc.contributor.authorLetelier Saavedra, Luz María
dc.contributor.authorRojas Orellana, Luis
dc.contributor.authorViviani García, Paola
dc.contributor.authorGonzález Candia, Antonio Felipe
dc.contributor.authorPérez Cruz, Pedro
dc.date.accessioned2022-08-09T14:59:01Z
dc.date.available2022-08-09T14:59:01Z
dc.date.issued2022
dc.date.updated2022-07-10T00:03:15Z
dc.description.abstractBackground: Cancer pain is one of the most frequent and relevant symptoms in cancer patients and impacts on patient’s quality of life. International and local standards recommend as an initial strategy the use of an analgesic scheme composed of strong opioids associated with adjuvants such as acetaminophen, based upon the assumption that combining drugs could have a better analgesic effect, could allow lowering opioid dosing, and could prevent the occurrence of adverse effects of opioids. However, there is uncertainty about the impact of acetaminophen as an adjuvant in patients who use strong opioids for moderate to severe pain management in cancer patients. The aim of this study is to assess the efficacy and safety of intravenous acetaminophen associated with strong opioids in hospitalized adult cancer patients who have moderate to severe cancer-related pain. Methods: We will perform a randomized double-blinded controlled study comparing intravenous acetaminophen 1 g 4 times a day versus placebo for 48 h as an adjuvant to strong opioids. We will assess pain intensity as a primary outcome, using the verbal numerical rating scale (VNRS, I0 to 10 scale with higher scores meaning higher pain intensity), and we will compare the mean difference in pain intensity between baseline and 48 h among the placebo and intervention groups. We estimate that a decrease of 1 point in the VNRS would be clinically significant. Assuming a standard deviation in pain intensity of 1.7 points, an alpha of 0.025, and a power of 0.8, we estimate a sample size of 112 patients, with 56 patients in each arm. Secondary outcomes include the difference in total opioid use between baseline and at 48 h among the groups, and adverse effects such as drowsiness, constipation, nausea, and vomiting would be evaluated. Discussion: The randomized, double-blind, placebo-controlled design is the best strategy to assess the efficacy of acetaminophen as an adjuvant in adult cancer patients with moderate to severe pain who are receiving strong opioids. We expect to contribute to national and international guidelines with these results.
dc.format.extent11 páginas
dc.fuente.origenAutoarchivo
dc.identifier.citationTrials. 2022 Jul 06;23(1):548
dc.identifier.doi10.1186/s13063-022-06442-2
dc.identifier.urihttps://doi.org/10.1186/s13063-022-06442-2
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/64505
dc.information.autorucEscuela de medicina ; Leiva, Ofelia ; 0000-0001-8136-3505 ; 167303
dc.information.autorucEscuela de medicina ; Castellano, Joel ; 0000-0001-9051-6892 ; 1020225
dc.information.autorucEscuela de medicina ; Letelier Saavedra, Luz María ; S/I ; 52245
dc.information.autorucEscuela de medicina ; Rojas Orellana, Luis ; S/I ; 135613
dc.information.autorucEscuela de medicina ; Viviani García, Paola ; S/I ; 729
dc.information.autorucEscuela de medicina ; González Candia, Antonio Felipe ; S/I ; 149421
dc.information.autorucEscuela de medicina ; Pérez Cruz, Pedro ; S/I ; 4140
dc.language.isoen
dc.nota.accesoContenido completo
dc.pagina.final11
dc.pagina.inicio1
dc.revistaTrials
dc.rightsacceso abierto
dc.rights.holderThe Author(s)
dc.subjectAcetaminophenes_ES
dc.subjectOpioidses_ES
dc.subjectCancer paines_ES
dc.subjectInpatientses_ES
dc.subject.ddc610
dc.subject.deweyMedicina y saludes_ES
dc.titleRandomized double-blind controlled trial to assess the efcacy of intravenous acetaminophen associated with strong opioids in the treatment of acute pain in adult cancer patients: study protocoles_ES
dc.typeartículo
dc.volumen23
sipa.codpersvinculados167303
sipa.codpersvinculados1020225
sipa.codpersvinculados52245
sipa.codpersvinculados135613
sipa.codpersvinculados729
sipa.codpersvinculados49421
sipa.codpersvinculados4140
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