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‘ DREAMFAST ’ A Double-blind Randomized Evaluation of Alfentanil and Morphine versus Fentanyl: Analgesia and Sleep Trial. A Lee, E O ’ Loughlin, LJ Roberts. Background. Patients using PCA fentanyl report awakening due to pain. Background. Patients using PCA fentanyl report awakening
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‘DREAMFAST’A Double-blind Randomized Evaluation of Alfentanil and Morphine versus Fentanyl: Analgesia and Sleep Trial A Lee, E O’Loughlin, LJ Roberts
Background • Patients using PCA fentanyl report awakening due to pain
Background • Patients using PCA fentanyl report awakening due to pain • Alfentanil and morphine combination • PACU: shorter time to patient comfort than morphine (Ludbrook et al 2001) • PCA: more rapid onset than morphine (NganKee et al 1999)
Hypothesis • Primary aim • To determine that an alfentanil/morphine combination used in PCA reduces pain-related sleep disturbance when compared to fentanyl PCA • Secondary aims • Safety and efficacy of alfentanil/morphine PCA • Sleep in the postoperative period
Methods • Double blind, randomized trial • Group AM: alfentanil 75mcg/morphine 1mg • Group F: fentanyl 20mcg • Pilot study: 88 patients per group required • Adult ASA 1-3 patients • Exclusion criteria • Randomization • Anaesthesia
Methods • Daily Pain Team review • Rescue protocol • First-line: 50% dose increase • Second-line: addition of ketamine infusion • Data collection 2nd post-operative morning • St Mary’s Hospital Sleep Questionnaire • PCA data: VAS, rescue analgesia, PONV, itch • Statistical analysis • Intention to treat • t-tests, Wilcoxon Rank Sum tests
Results: Analgesia Efficacy VRS = Verbal Rating Scale; * median (range)
Results: Side Effects • No cases of significant sedation or respiratory depression in either group • Group AM • Had a lower incidence of nausea and vomiting (18% vs. 35%, p=0.015) • Reported more itch (35% vs. 19%, p=0.017)
Discussion • Alfentanil/morphine did not reduce pain-related awakenings by 50% • Alfentanil/morphine may provide more effective analgesia than fentanyl • Limitations • Powered to detect a 50% or greater reduction in sleep disruption • Sleep disruption is subjective • Reliance on retrospective recall • Trial protocol reflects realistic postoperative management
Conclusions • Postoperative sleep disruption is common and multifactorial • The alfentanil/morphine combination in PCA did not reduce pain-related awakenings by more than 50% • The alfentanil/morphine combination in PCA was associated with better analgesia