Incidence and impact of remimazolam-induced paradoxical reactions in pediatric same-day bidirectional endoscopy: a randomized, controlled clinical trial.

BACKGROUND

Remimazolam, a novel ultrashort-acting benzodiazepine, offers advantages such as fast onset, rapid recovery, organ-independent metabolism, and cardiorespiratory stability. Intravenous (IV) remimazolam administration could induce paradoxical reactions (PRs) in children, including excitement, body movement and fear. The aim of this study was to explore the incidence of PRs and their impact on sedation efficacy when different premedication remimazolam doses were administered before pediatric same-day bidirectional endoscopy.

METHODS

This prospective, randomized, controlled clinical trial was conducted at a single center from May to September 2024. Of the 333 eligible children aged <12 years, 324 were enrolled and randomly assigned to the IV remimazolam 0.1 mg·kg-1 (R1), 0.2 mg·kg-1 (R2) and 0.3 mg·kg-1 (R3) groups. The primary outcome was PR incidence, whereas the secondary outcomes included PR severity, sedation-related time, factors affecting PR occurrence, the influence of PR on the sedative effect, vital signs during the procedure and adverse events.

RESULTS

The PR incidence rates in the R1, R2 and R3 groups were 38.0%, 21.0% and 17.1%, respectively (P<0.001). PR occurred less frequently in school-age children than in preschoolers. Children with PR had a lower incidence of respiratory depression. PR did not adversely affect procedural completion rates or short-term recovery outcomes. All children remained hemodynamically stable, with a low incidence of adverse reactions, and recovered well postprocedure.

CONCLUSIONS

PR was more prevalent in the lower premedication dose group and younger children but did not adversely affect sedation or prognosis.