Evidence map›Paper›PMID 39568028›Full record

Trial reportScandinavian journal of trauma, resuscitation and emergency medicine2024

A randomized clinical trial of intranasal dexmedetomidine versus inhaled nitrous oxide for procedural sedation and analgesia in children.

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

Abstract readRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
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 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Trial
  2. Observational
  3. Article
  4. Article
  5. 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

7 authors.

Anna NikulaDepartment of Emergency Medicine and Services, Helsinki University, University of Helsinki, P.O. Box, Helsinki, 00014, Finland. anna.nikula@helsinki.fi.
Malin Ryd RinderDepartment of Emergency Care for Children Astrid Lindgren Children´s Hospital, Department of Women's and Children's Health Karolinska Institutet, Stockholm, 17176, Sweden.
Stefan LundebergDepartment of Pediatric Anesthesia and Intensive Care, Department of Physiology and Pharmacology, Astrid Lindgren Children's Hospital, Karolinska University Hospital, Karolinska Institutet, Stockholm, 17176, Sweden.
Mitja LääperiLääperi Statistical Consulting, Helsinki, Finland.
Katri SandholmDepartment of Emergency Care for Children Astrid Lindgren Children´s Hospital, Department of Women's and Children's Health Karolinska Institutet, Stockholm, 17176, Sweden.
Maaret CastrénDepartment of Emergency Medicine and Services, Helsinki University and Helsinki University Hospital, University of Helsinki, P.O. Box 4, Helsinki, 00014, Finland.
Lisa KurlandDepartment of Medical Sciences, Örebro University, Örebro, SE-701 82, Sweden.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProcedural sedation and analgesia is an important part of pediatric emergency care, safe and clinically useful alternatives for adequate management are necessary. The objective of this clinical trial was to evaluate the non-inferiority of intranasal dexmedetomidine to nitrous oxide with respect to analgesia for a painful procedure in children 3-15 years of age.

methodsThis prospective, equally randomized, open-label, non-inferiority trial was conducted at a Pediatric Emergency Department. Previously healthy children 3-15 years of age, with an extremity fracture or luxation or a burn and requiring procedural sedation and analgesia were eligible. Patients were randomized to receive either intranasal dexmedetomidine or inhaled nitrous oxide. The primary outcome measure was highest pain level during the procedure, assessed with Face, Legs, Activity, Cry, Consolability scale (FLACC). Mann-Whitney U test (continuous variables) and Fisher's test (categorical variables) were used for statistical analysis.

resultsThe highest FLACC was median 4 (IQR 3-6) with intranasal dexmedetomidine and median 4 (IQR 2-6) with nitrous oxide. The median of the difference between samples from each group for FLACC was 0 with 95%CI (0-1), thus intranasal dexmedetomidine was not inferior to nitrous oxide with respect to the level of pain during the procedure. The same method for procedural sedation and analgesia would be accepted by 52/74 (82.5%) children and 65/74 (91.5%) parents in the intranasal dexmedetomidine group respectively 59/74 (88.1%) versus 70/74 (94.6%) with nitrous oxide. No serious adverse events were reported.

conclusionsThe results of this trial support that intranasal dexmedetomidine is not inferior to 50% nitrous oxide in providing analgesia for a painful procedure in children 3-15 years of age and can be considered as an alternative to 50% nitrous oxide for procedural sedation and analgesia.

trial registrationEudraCT 201,600,377,317, April 20, 2017. https://eudract.ema.europa.eu/ .

Indexed as

Administration, IntranasalDexmedetomidineNitrous OxideAdministration, InhalationAdolescentAnalgesics, Non-NarcoticChildChild, PreschoolFemaleHumansHypnotics and SedativesMalePain ManagementPain MeasurementProcedural SedationProspective StudiesAnalgesics, Non-NarcoticDexmedetomidineHypnotics and SedativesNitrous OxideAnalgesiaChildrenDexmedetomidineEsketamineIntranasalProcedureSedation

Identifiers

PMID39568028
PMCPMC11577660

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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.