Evidence map›Paper›PMID 26887587›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2016

A randomised, double-blind controlled trial of intranasal midazolam for the palliation of dyspnoea in patients with life-limiting disease.

Janet Hardy, Clare Randall, Eve Pinkerton, Christopher Flatley, Kristen Gibbons, Simon Allan

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 4 pooled it
4.3field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 4 syntheses or guidelines pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Observational
  6. Midazolam: an essential palliative care drug.Palliative care and social practice · 2020
    Review
  7. Fentanyl treatment for end-of-life dyspnoea relief in advanced cancer patients.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2019
    Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Janet HardyDepartment of Palliative and Supportive Care, Mater Health Services and Mater Research Institue - University of Queensland, South Brisbane, QLD, Australia. janet.hardy@mater.org.au.
Clare RandallArohanui Hospice, Palmerston North, New Zealand.
Eve PinkertonDepartment of Palliative and Supportive Care, Mater Health Services and Mater Research Institue - University of Queensland, South Brisbane, QLD, Australia.
Christopher FlatleyMater Research Office, Mater Research Institute - University of Queensland, South Brisbane, QLD, Australia.
Kristen GibbonsMater Research Office, Mater Research Institute - University of Queensland, South Brisbane, QLD, Australia.
Simon AllanArohanui Hospice, Palmerston North, New Zealand.
Mater Health Services · AUMater Research · AUUniversity of Queensland · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAnxiety is a major component of breathlessness and is often palliated with benzodiazepines. Midazolam is a short-acting water-soluble benzodiazepine with a rapid onset of action and short half-life. Intranasal midazolam had been shown to be of marked clinical benefit in an uncontrolled pilot study for the control of dyspnoea. A blinded randomised controlled study was therefore undertaken across four Australasian palliative care services.

methodsAll participants received six numbered study nasal spray (SNS) bottles, three of which contained midazolam and three placebo. They were instructed to use one SNS bottle on each day they were breathless, for 6 days within 2 weeks. Dyspnoea scores were recorded before and at set time intervals following the first use of each SNS bottle.

resultsAcross all SNS bottles, the maximum change of 2.1 on an 11-point numerical rating scale was seen at 60 min. There was no difference in dyspnoea score between the two arms. Approximately 50 % of participants in each arm had a positive response (i.e. ≥2 point change in dyspnoea score from baseline). Anxiety scores at baseline were low. The most common adverse event was local nasal reactions.

conclusionIntranasal midazolam had no clinical benefit over intranasal placebo for the control of dyspnoea. The low level of anxiety at baseline and dose of active drug delivered may have been important factors. Many participants found the SNS bottles to be a challenging mode of drug delivery. This study confirms the importance of placebo-controlled trials for defining best clinical practise.

Indexed as

Administration, IntranasalAgedAnxietyDouble-Blind MethodDrug Delivery SystemsDyspneaFemaleHumansHypnotics and SedativesMaleMidazolamMiddle AgedPilot ProjectsHypnotics and SedativesMidazolamAnxietyDyspnoeaIntranasalMidazolam

Identifiers

PMID26887587
OpenAlexW2283531954

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.