Intranasal dexmedetomidine vs. nitrous oxide for procedural sedation in juvenile idiopathic arthritis (INDEXJIA): a randomized crossover clinical trial.

This study aims to compare intranasal dexmedetomidine with inhaled nitrous oxide for procedural pain relief and sedation during intra-articular injections in a pediatric rheumatology outpatient clinic. Patients from 1 to 18 years-of-age requiring 1-5 intra-articular injections were randomized to receive 2 µg/kg intranasal dexmedetomidine or inhaled nitrous oxide in the first visit. When the patient required subsequent treatment visit, the other sedative was administered. The primary outcome was patient-reported pain immediately after recovery from sedation. Hemodynamic and respiratory parameters, level of sedation and patient's pain assessed by the parent, rheumatologist, and nurse were secondary outcomes. Out of 119 eligible patients, 68 were included, and 43 received both medications at two separate visits. Overall pain experience was mild and did not differ between dexmedetomidine and nitrous oxide in patient-reported pain immediately after the procedure (difference, 0.2; 95% CI - 0.7 to 1.2, p = 0.65) but the patients recalled milder pain after nitrous oxide in the follow-up survey (difference, - 1.3; 95% CI - 2.3 to - 0.3; p = 0.01). Milder pain was reported during the second visit compared to the first visit regardless of the sedative used (difference, - 1.2; 95% CI - 2.1 to - 0.2; p = 0.02). In the follow-up survey, majority (69%) of patients would prefer nitrous oxide to dexmedetomidine for sedation in future.

conclusionsBoth intranasal dexmedetomidine and inhaled nitrous oxide offered effective analgosedation for intra-articular injections in children. Nitrous oxide resulted in better patient experience and became their preference for future sedation. Trial registration: ClinicalTrials.gov TRN: NCT03069638. https://clinicaltrials.gov/study/NCT03069638 . The date of registration 2016-12-20. WHAT IS KNOWN: • Children suffering juvenile idiopathic arthritis often require repeated intra-articular injections. • Procedural sedation is being used during these procedures. WHAT IS NEW: • When intranasal dexmedetomidine and nitrous oxide was compared in a crossover design both agents provided effective analgosedation without difference in patient-reported pain immediately after the procedure. • Despite this, most patients favored nitrous oxide for future sedation.