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Randomized Controlled Trial
. 2024 Nov 20;32(1):117.
doi: 10.1186/s13049-024-01292-0.

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

Anna Nikula  1 , Malin Ryd Rinder  2 , Stefan Lundeberg  3 , Mitja Lääperi  4 , Katri Sandholm  2 , Maaret Castrén  5 , Lisa Kurland  6
Affiliations
Randomized Controlled Trial

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

Anna Nikula et al. Scand J Trauma Resusc Emerg Med. .

Abstract

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/ .

Keywords: Analgesia; Children; Dexmedetomidine; Esketamine; Intranasal; Procedure; Sedation.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study was approved by the Swedish Ethical Review Authority (2017/824 − 31/1). Informed consent was provided by both parents of every child enrolled in this trial. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Participant flow chart
Fig. 2
Fig. 2
Highest pain level during the procedure. Pain level was assessed with Face, Legs, Activity, Cry, Consolability scale (FLACC). This diagram shows the distribution of FLACC scores per drug. The median (IQR) of highest FLACC with patients receiving intranasal dexmedetomidine was 4 (3-6) and nitrous oxide 4 (2-6), p-value 0.41. The median of the difference between samples from each group for FLACC was 0 with 95%CI (0–1) which is within the predefined limit for non-inferiority
Fig. 3
Fig. 3
Highest sedation scores during the procedure. Sedation level was assessed with Ramsay sedation scale. This diagram shows the distribution of Ramsay scores per drug. The groups differ significantly, p-value <0.001.
See this image and copyright information in PMC

References

    1. Yang BW, Waters PM. Conscious sedation and reduction of fractures in the paediatric population: an orthopaedic perspective. J Child Orthop. 2019;13(3):330–3. - PMC - PubMed
    1. Boyle A, Dixon V, Fenu E, Heinz P. Sedation of children in the emergency department for short painful procedures compared with theatre, how much does it save? Economic evaluation. Emerg Med J. 2011;28(5):383–6. - PubMed
    1. Choudhary D, Dhillon R, Chadha K, Cross K, Carnevale FP. National Survey to describe the current patterns of Procedural Sedation practices among Pediatric Emergency Medicine practitioners in the United States. Pediatr Emerg Care. 2022;38(1):e321–8. - PubMed
    1. Sahyoun C, Cantais A, Gervaix A, Bressan S, Löllgen R, Krauss B. Pediatric procedural sedation and analgesia in the emergency department: surveying the current European practice. Eur J Pediatr. 2021;180(6):1799–813. - PMC - PubMed
    1. Humphrey GB, Boon CM, van Linden GF, van de Wiel HB. The occurrence of high levels of acute behavioral distress in children and adolescents undergoing routine venipunctures. Pediatrics. 1992;90(1 Pt 1):87–91. - PubMed

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