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A randomized clinical trial of intranasal dexmedetomidine versus inhaled nitrous oxide for procedural sedation and analgesia in children
Department of Emergency Medicine and Services, Helsinki University, University of Helsinki, Helsinki, Finland.
Department of Emergency Care for Children Astrid Lindgren Children´s Hospital, Department of Women’s and Children’s Health Karolinska Institutet, Stockholm, Sweden.
Department of Pediatric Anesthesia and Intensive Care, Department of Physiology and Pharmacology, Astrid Lindgren Children’s Hospital, Karolinska University Hospital, Karolinska Institutet, Stockholm, Sweden.
Lääperi Statistical Consulting, Helsinki, Finland.
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2024 (English)In: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine, E-ISSN 1757-7241, Vol. 32, no 1, article id 117Article in journal (Refereed) Published
Abstract [en]

Background: Procedural 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.

Methods: This 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.

Results: The 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.

Conclusions: The 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 registration: EudraCT 201,600,377,317, April 20, 2017. https://eudract.ema.europa.eu/.

Place, publisher, year, edition, pages
BioMed Central (BMC), 2024. Vol. 32, no 1, article id 117
Keywords [en]
Intranasal, Dexmedetomidine, Esketamine, Procedure, Sedation, Analgesia, Children
National Category
Anesthesiology and Intensive Care
Identifiers
URN: urn:nbn:se:oru:diva-117599DOI: 10.1186/s13049-024-01292-0ISI: 001359491700001PubMedID: 39568028Scopus ID: 2-s2.0-85210074782OAI: oai:DiVA.org:oru-117599DiVA, id: diva2:1918077
Note

Funding: Personal research funding for doctoral research from Päivikki and Sakari Sohlberg Foundation, Stiftelsen Samariten, Finska läkaresällskapet. Open Access funding provided by University of Helsinki (including Helsinki University Central Hospital).

Available from: 2024-12-04 Created: 2024-12-04 Last updated: 2024-12-04Bibliographically approved

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Kurland, Lisa

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