A pilot, parallel-group, blinded, placebo-controlled, randomiseD, pRagmatic clinical trial investigating the Effect of temazepAM on objective and subjective measures of sleep in critically ill patients (the DREAM trial).

OBJECTIVE

Patients in the intensive care unit (ICU) suffer from disturbed sleep and pharmacological sleep aids are frequently prescribed despite limited data on their efficacy. The objective of this study was to assess the effect of a single nocturnal dose of the benzodiazepine temazepam on sleep duration and quality in ICU patients.

DESIGN

Prospective, single-centre, blinded, placebo-controlled, parallel-group, randomised clinical trial.

SETTING

A tertiary ICU in Australia.

PARTICIPANTS

Adult ICU patients whose treating clinician considered that a pharmacological sleep aid was indicated.

INTERVENTIONS: A single weight- and age-adjusted dose of temazepam (10-30 mg) or a matching placebo was administered enterally at 21:00 h.

MAIN OUTCOME MEASURES: The primary outcome was total sleep time between 21:00 and 07:00 h by hourly structured nurse assessment. Secondary outcomes included the evaluation of sleep quality, independently determined by the bedside nurse and patient using the Richards-Campbell Sleep Questionnaire.

RESULTS

Between October 2020 and May 2024, 56 patients received temazepam (n = 28) or placebo (n = 28). The mean (standard deviation) total sleep time with temazepam was 349 (120) vs. placebo 291 (124) minutes; difference = 57 min (95% confidence intervals: -11 to 130); p = 0.10. No differences in total Richards-Campbell Sleep Questionnaire sleep quality were observed when assessed by the nurse (57 (17) vs. 49 (23), p = 0.15) or by the patient (50 (28) vs. 51 (23), p = 0.70).

CONCLUSION

A single dose of temazepam was not observed to improve the duration or quality of nocturnal sleep for patients in the ICU.

TRIAL REGISTRATION: Retrospectively registered with the Australian and New Zealand Clinical Trials Registry on 11th June 2021 (ACTRN 12621000742875).