Boaz Gedaliahu Samolsky Dekel1, Marco Tomasi2, Alessio Vasarri3, Alberto Gori2, Marco Adversi4, Anna Castagnoli4, GianFranco Di Nino1, Rita Maria Melotti1. 1. Department of Medical and Surgery Sciences, University of Bologna, Bologna, Italy; Azienda Ospedaliera-Universitaria di Bologna Policlinico S. Orsola-Malpighi, Bologna, Italy; Post Graduate School of Anesthesia and Intensive Care, University of Bologna, Bologna, Italy. 2. Post Graduate School of Anesthesia and Intensive Care, University of Bologna, Bologna, Italy. 3. Department of Medical and Surgery Sciences, University of Bologna, Bologna, Italy. 4. Department of Medical and Surgery Sciences, University of Bologna, Bologna, Italy; Azienda Ospedaliera-Universitaria di Bologna Policlinico S. Orsola-Malpighi, Bologna, Italy.
Abstract
OBJECTIVES: Opioid titration is the first challenging stage for rapid control of moderate/severe cancer pain. Evidence shows that sustained-release formulations may be used for opioid titration. We set a pilot assessment of the efficacy and tolerability of our in-house protocol (continuous and on demand opioids [CoDem]) of the association of sustained-release oxycodone and immediate-release morphine as rescue dose for opioid titration/rotation in opioid-naïve (NAOP, n = 13), tolerant to weak (WOP, n = 20), or strong opioids (STOP, n = 44) in-patients with moderate/severe cancer pain. METHODS: Observational and retrospective analysis of cancer in-patients treated for ≥7 days with the CoDem protocol. OUTCOME MEASURES: Pain intensity (patients self-reported pain with numerical rating scale [NRS] under static [NRSs] and dynamic [NRSd] conditions), amount of drug consumption, opioid adverse effects, and patient satisfaction. EFFICACY ENDPOINTS: In more than 50 percent of the patients and in <72 hours, steady NRSs and NRSd score reduction of at least two points, NRSs ≤ 3 and NRSd ≤4; and mean daily morphine consumption < mean of one rescue dose and t1:t6 ratio of mean oxycodone daily dose < 1:2. RESULTS: Endpoints were reached within 24 hours both within the sample and subgroups. Only NAOP patients reached NRSd ≤ 4 endpoint within 48 hours. Against moderate and transient adverse effects, most patients (84.4 percent) found pain treatment to be good or excellent. CONCLUSIONS: The CoDem protocol was shown to be effective and reasonably tolerated for titration for moderate/severe cancer pain relief in both opioid-naïve or opioid-tolerant cancer in-patients. This pilot assessment warrants prospective and comparative studies with larger samples for more generalized results.
OBJECTIVES: Opioid titration is the first challenging stage for rapid control of moderate/severe cancer pain. Evidence shows that sustained-release formulations may be used for opioid titration. We set a pilot assessment of the efficacy and tolerability of our in-house protocol (continuous and on demand opioids [CoDem]) of the association of sustained-release oxycodone and immediate-release morphine as rescue dose for opioid titration/rotation in opioid-naïve (NAOP, n = 13), tolerant to weak (WOP, n = 20), or strong opioids (STOP, n = 44) in-patients with moderate/severe cancer pain. METHODS: Observational and retrospective analysis of cancer in-patients treated for ≥7 days with the CoDem protocol. OUTCOME MEASURES: Pain intensity (patients self-reported pain with numerical rating scale [NRS] under static [NRSs] and dynamic [NRSd] conditions), amount of drug consumption, opioid adverse effects, and patient satisfaction. EFFICACY ENDPOINTS: In more than 50 percent of the patients and in <72 hours, steady NRSs and NRSd score reduction of at least two points, NRSs ≤ 3 and NRSd ≤4; and mean daily morphine consumption < mean of one rescue dose and t1:t6 ratio of mean oxycodone daily dose < 1:2. RESULTS: Endpoints were reached within 24 hours both within the sample and subgroups. Only NAOPpatients reached NRSd ≤ 4 endpoint within 48 hours. Against moderate and transient adverse effects, most patients (84.4 percent) found pain treatment to be good or excellent. CONCLUSIONS: The CoDem protocol was shown to be effective and reasonably tolerated for titration for moderate/severe cancer pain relief in both opioid-naïve or opioid-tolerant cancer in-patients. This pilot assessment warrants prospective and comparative studies with larger samples for more generalized results.