Evidence map›Paper›PMID 38439043›Full record

Trial reportScandinavian journal of trauma, resuscitation and emergency medicine2024

A randomized double-blind trial of intranasal dexmedetomidine versus intranasal esketamine for procedural sedation and analgesia in young children.

Anna Nikula, Stefan Lundeberg, Malin Ryd Rinder, Mitja Lääperi, Katri Sandholm, Maaret Castrén, Lisa Kurland

Open access · goldAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Scandinavian journal of trauma, resuscitation and emergency medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
5.1field-weighted citation impact, top 5% 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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Observational
  6. Review
  7. Review
  8. Article
  9. Article
  10. A wrong conclusion.Scandinavian journal of trauma, resuscitation and emergency medicine · 2024
    Article
  11. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 2 countries.

Anna NikulaDepartment of Emergency Medicine and Services, Helsinki University, P.O. Box 4, 00014, Helsinki, Finland. anna.nikula@helsinki.fi.ORCID http://orcid.org/0009-0007-0263-8728
Stefan LundebergDepartment of Pediatric Anesthesia and Intensive Care, Astrid Lindgren Children's Hospital, Karolinska University Hospital, 171 76, Stockholm, Sweden.
Malin Ryd RinderDepartment of Emergency Care for Children, Astrid Lindgren Children's Hospital, Karolinska University Hospital, 171 76, Stockholm, Sweden.
Mitja LääperiLääperi Statistical Consulting, Espoo, Finland.
Katri SandholmDepartment of Emergency Care for Children, Astrid Lindgren Children's Hospital, Karolinska University Hospital, 171 76, Stockholm, Sweden.
Maaret CastrénDepartment of Emergency Medicine and Services, Helsinki University and Helsinki University Hospital, P.O. Box 4, 00014, Helsinki, Finland.
Lisa KurlandDepartment of Medical Sciences, Örebro University, 701 82, Örebro, Sweden.
Karolinska University Hospital · SEHelsinki University Hospital · FIÖrebro University · SEUniversity of Helsinki · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProcedural sedation and analgesia are commonly used in the Emergency Departments. Despite this common need, there is still a lack of options for adequate and safe analgesia and sedation in children. The objective of this study was to evaluate whether intranasal dexmedetomidine could provide more effective analgesia and sedation during a procedure than intranasal esketamine.

methodsThis was a double-blind equally randomized (1:1) superiority trial of 30 children aged 1-3 years presenting to the Emergency Department with a laceration or a burn and requiring procedural sedation and analgesia. Patients were randomized to receive 2.0 mcg/kg intranasal dexmedetomidine or 1.0 mg/kg intranasal esketamine. The primary outcome measure was highest pain (assessed using Face, Legs, Activity, Cry, Consolability scale (FLACC)) during the procedure. Secondary outcomes were sedation depth, parents' satisfaction, and physician's assessment. Comparisons were done using Mann-Whitney U test (continuous variables) and Fisher's test (categorical variables).

resultsAdequate analgesia and sedation were reached in 28/30 patients. The estimated sample size was not reached due to changes in treatment of minor injuries and logistical reasons. The median (IQR) of highest FLACC was 1 (0-3) with intranasal dexmedetomidine and 5 (2-6.75) with intranasal esketamine, (p-value 0.09). 85.7% of the parents with children treated with intranasal dexmedetomidine were "very satisfied" with the procedure and sedation compared to the 46.2% of those with intranasal esketamine, (p-value 0.1). No severe adverse events were reported during this trial.

conclusionsThis study was underpowered and did not show any difference between intranasal dexmedetomidine and intranasal esketamine for procedural sedation and analgesia in young children. However, the results support that intranasal dexmedetomidine could provide effective analgesia and sedation during procedures in young children aged 1-3 years with minor injuries.

trial registrationEudra-CT 2017-00057-40, April 20, 2017. https://eudract.ema.europa.eu/.

Indexed as

AnalgesiaDexmedetomidineKetamineChildChild, PreschoolHumansPainPain ManagementDexmedetomidineEsketamineKetamineAnalgesiaChildrenDexmedetomidineEsketamineIntranasalProcedureSedation

Identifiers

PMID38439043
PMCPMC10913425
OpenAlexW4392429347

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.