Evidence map›Paper›PMID 34649849›Full record

ArticleBMJ open2021

Design and reporting characteristics of clinical trials investigating sedation practices in the paediatric intensive care unit: a scoping review by SCEPTER (Sedation Consortium on Endpoints and Procedures for Treatment, Education and Research).

Jennifer Jooyoung Lee, Jerri C Price, Jennifer Gewandter, Bethea A Kleykamp, Katherine V Biagas, Maryam Y Naim, Denham Ward, Robert H Dworkin, Lena S Sun

Abstract readScoping Review
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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

9 authors.

Jennifer Jooyoung LeeAnesthesiology, Columbia University Irving Medical Center, New York, New York, USA.ORCID 0000-0001-5456-1688
Jerri C PriceAnesthesiology, Columbia University Irving Medical Center, New York, New York, USA.
Jennifer GewandterAnesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, New York, USA.
Bethea A KleykampAnesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, New York, USA.
Katherine V BiagasPediatrics, Stony Brook University Renaissance School of Medicine, Stony Brook, New York, USA.
Maryam Y NaimAnesthesiology, Critical Care and Pediatrics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.ORCID 0000-0002-9127-0043
Denham WardAnesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, New York, USA.
Robert H DworkinAnesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, New York, USA.
Lena S SunAnesthesiology and Pediatrics, Columbia University Irving Medical Center, New York, New York, USA lss4@cumc.columbia.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo conduct a scoping review of sedation clinical trials in the paediatric intensive care setting and summarise key methodological elements.

designScoping review. DATA SOURCES: PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature and grey references including ClinicalTrials.gov from database inception to 3 August 2021. STUDY SELECTION: All human trials in the English language related to sedation in paediatric critically ill patients were included. After title and abstract screening, full-text review was performed. 29 trials were eligible for final analysis. DATA EXTRACTION: A coding manual was developed and pretested. Trial characteristics were double extracted.

resultsThe majority of trials were single centre (22/29, 75.9%), parallel group superiority (17/29, 58.6%), double-blinded (18/29, 62.1%) and conducted in an academic setting (29/29, 100.0%). Trial enrolment (≥90% planned sample size) was achieved in 65.5% of trials (19/29), and retention (≥90% enrolled subjects) in 72.4% of trials (21/29). Protocol violations were reported in nine trials (31.0%). The most commonly studied cohorts were mechanically ventilated patients (28/29, 96.6%) and postsurgical patients (11/29, 37.9%) with inclusion criteria for age ranging from 0±0.5 to 15.0±7.3 years (median±IQR). The median age of enrolled patients was 1.7 years (IQR=4.4 years). Patients excluded from trials were those with neurological impairment (21/29, 72.4%), complex disease (20/29, 69.0%) or receipt of neuromuscular blockade (10/29, 34.5%). Trials evaluated drugs/protocols for sedation management (20/29, 69.0%), weaning (3/29, 10.3%), daily interruption (3/29, 10.3%) or protocolisation (3/29, 10.3%). Primary outcome measures were heterogeneous, as were assessment instruments and follow-up durations.

conclusionsThere is substantial heterogeneity in methodological approach in clinical trials evaluating sedation in critically ill paediatric patients. These results provide a basis for the design of future clinical trials to improve the quality of trial data and aid in the development of sedation-related clinical guidelines.

Indexed as

AnesthesiaRespiration, ArtificialChildChild, PreschoolCritical IllnessHumansInfantInfant, NewbornIntensive Care UnitsIntensive Care Units, PediatricLength of Stayclinical trialspaediatric intensive & critical careprotocols & guidelinesstatistics & research methods

Identifiers

PMID34649849
PMCPMC8522672

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.