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Randomized trial · measured other health measures

Trial in 334 intensive care patients on breathing machines: no clear change in delirium

Mekontso Dessap and colleagues · Intensive care medicine · 2025

Original title: Melatonin for prevention of delirium in patients receiving mechanical ventilation in the intensive care unit: a multiarm multistage adaptive randomized controlled clinical trial (DEMEL).

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What the study found

No difference

Delirium was 80/147 (54.4%) with low-dose melatonin vs 85/154 (55.2%) with placebo, risk ratio, 0.986 [95% CI 0.803 to 1.211]. Sleep quality and other secondary results were similar between groups.

The study at a glance

Type of study
Randomized trial
Who or what was studied
334 people · adults in intensive care on breathing machines
What was tested
Melatonin 0.3 mg or 3 mg each night vs placebo, up to 14 nights; main goal was delirium, sleep quality was a side measure
What it measured
Several kinds of outcomes
Daily amount
3 mg a day
How long
2 weeks
Trial registration
NCT03524937
Who has a stake
Company stake
Some authors report fees from medical device and drug firms; no melatonin maker named.
Journal
Intensive care medicine, 2025
Source
PubMed record 40608082. This page is based on the abstract only.

How much this study counts

  • ✓Randomized: people were put into groups by chance, so the groups start out alike.
  • ✓Compared with a placebo, a dummy treatment.
  • ✓Large: 334 people.
  • –Short: 2 weeks. Longer-term effects are unknown.
  • •Measured several kinds of outcomes.
  • –Company stake: Some authors report fees from medical device and drug firms; no melatonin maker named.
  • •Summarized from the PubMed abstract only. The full paper may hold details the abstract leaves out.

✓ Strength– Limit• Note

These points come from fixed rules about the type of study, its size and length, what it measured, and who has a stake. Every study on Digestery gets the same rules.

Where this study sits

Each dot is one on-topic paper on this question. Steps near the top answer the question more directly.

↑ Stronger evidence

  1. Trials in people: sleep onset and sleep quality

    8

    2 benefit, 2 mixed, 4 no difference

  2. Trials in people: other measures

    2

    1 benefit, 1 no difference

    ↑ This study is the ringed dot

  3. Trials in people: lab tests or safety

    0

    None among the papers we read.

  4. Population studies

    0

    None among the papers we read.

  5. Blood levels and genes

    0

    None among the papers we read.

↓ Weaker evidence

  • Points to benefit
  • Mixed
  • No difference
  • No direction
  • Points to harm

How it fits with the other research

The short answer to “Does melatonin help you sleep?”

A small effect, clearer in children.

Confidence: low. Based on 20 on-topic papers.

Read the full answer

Few other papers sit on the same step, so there is little to compare it with.

Other papers on the same step

See all 20 studies on this question

How this page was made

Label

First read of the abstract
Claude Sonnet
Independent second read
Claude Haiku
Differences settled
The reviewer corrected 1 field after reading the abstract. Claude Opus 5.5.
Headline
Claude Sonnet, from the checked study record. A script checked its numbers and wording.
Numbers
Checked against the abstract by a script
“How much this study counts”
Fixed rules, the same for every study
Source check by a person
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