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

Content Provider	Springer Nature : BioMed Central
Author	Nikula, Anna Lundeberg, Stefan Ryd Rinder, Malin Lääperi, Mitja Sandholm, Katri Castrén, Maaret Kurland, Lisa
Abstract	Background Procedural 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. Methods This 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). Results Adequate 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. Conclusions This 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 registration: Eudra-CT 2017-00057-40, April 20, 2017. https://eudract.ema.europa.eu/
Related Links	https://sjtrem.biomedcentral.com/counter/pdf/10.1186/s13049-024-01190-5.pdf
Ending Page	9
Page Count	9
Starting Page	1
File Format	HTM / HTML
ISSN	17577241
DOI	10.1186/s13049-024-01190-5
Journal	Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine
Issue Number	1
Volume Number	32
Language	English
Publisher	BioMed Central
Publisher Date	2024-03-04
Access Restriction	Open
Subject Keyword	Scandinavian Journal of Trauma Resuscitation and Emergency Medicine Emergency Medicine Traumatic Surgery Intranasal Dexmedetomidine Esketamine Procedure Sedation Analgesia Children
Content Type	Text
Resource Type	Article
Subject	Emergency Medicine Critical Care and Intensive Care Medicine
Journal Impact Factor	3/2023
5-Year Journal Impact Factor	3.5/2023

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

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

Efficacy of intranasal dexmedetomidine-esketamine sedation for pediatric acceptance of facemask: single-center, double-blind, randomized, controlled trial

Prehospital procedural sedation and analgesia agent selection: propofol, etomidate, ketamine

A comparative study of esketamine-dexmedetomidine and sufentanil-dexmedetomidine for sedation and analgesia in lung tumor percutaneous radiofrequency ablation (PRFA): a randomized double-blind clinical trial

Procedural sedation by advanced practice providers in the emergency medical service in the Netherlands: a retrospective study

A Comparison of Intranasal Dexmedetomidine, Esketamine or a Dexmedetomidine-Esketamine Combination for Induction of Anaesthesia in Children: A Randomized Controlled Double-Blind Trial

Efficacy and safety of procedural sedation with propofol in a country with a young emergency medicine training program

Remifentanil versus fentanyl for analgesia based sedation to provide patient comfort in the intensive care unit: a randomized, double-blind controlled trial [ISRCTN43755713]

Experimental hypothermia by cold air: a randomized, double-blind, placebo-controlled crossover trial

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

Similar Documents

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

Efficacy of intranasal dexmedetomidine-esketamine sedation for pediatric acceptance of facemask: single-center, double-blind, randomized, controlled trial

Prehospital procedural sedation and analgesia agent selection: propofol, etomidate, ketamine

A comparative study of esketamine-dexmedetomidine and sufentanil-dexmedetomidine for sedation and analgesia in lung tumor percutaneous radiofrequency ablation (PRFA): a randomized double-blind clinical trial

Procedural sedation by advanced practice providers in the emergency medical service in the Netherlands: a retrospective study

A Comparison of Intranasal Dexmedetomidine, Esketamine or a Dexmedetomidine-Esketamine Combination for Induction of Anaesthesia in Children: A Randomized Controlled Double-Blind Trial

Efficacy and safety of procedural sedation with propofol in a country with a young emergency medicine training program

Remifentanil versus fentanyl for analgesia based sedation to provide patient comfort in the intensive care unit: a randomized, double-blind controlled trial [ISRCTN43755713]

Experimental hypothermia by cold air: a randomized, double-blind, placebo-controlled crossover trial

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