‘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(Ngan Kee 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
Results212 enrolled
206 randomized
Group AM n = 102
Primary outcome data
n = 90
Group F n = 104
Primary outcome data
n = 85
6 excluded
Results: Pain-related Sleep Disruption
p = 0.40
Results: Sleep Disruption
Results: Causes of Sleep Disruption
23%
49%
6%
22%
Group AM
Results: Analgesia Efficacy
Group AM
Group F p
VRS Day 1* 2 (0-8) 3 (0-8) 0.003
VRS Day 2* 1 (0-8) 2 (0-7) 0.13
Dose increase (%)
5 13 0.054
Ketamine added (%)
2 14 0.001
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