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/.
