‘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