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End-of-Surgery Remimazolam Bolus Reduces Emergence Delirium in Children Undergoing Tonsillectomy and Adenoidectomy: A Randomized, Triple-Blind, Placebo-Controlled Trial

In brief

Remimazolam cut emergence delirium from 21% to 2% after children's tonsil surgery

In a randomized trial of 110 children aged 3 to 9, a remimazolam dose at the end of surgery reduced delirium at extubation from 11 cases to 1. Median emergence time was 10 minutes in both groups, with no significant difference in airway complications. The trial supports a rapid-acting option, but larger studies are needed to confirm the result.

Journal
Biomedicines (Q1)
Published
19 September 2026
Study design
Randomized controlled trial
Evidence level
Level 1, High (CEBM 1b)
Authors
Grgur Prižmić, Filip Periš, Ana Maria Mitar, Ana Bego, Ana Šarić Jadrijev, Toni Kljaković-Gašpić
PMID
42792855
DOI
10.3390/biomedicines14092115

Why clinicians should know about it

  • Picked for Otorhinolaryngology (top studies of the week, 27 September 2026): Remimazolam bolus reduces emergence delirium after tonsillectomy
  • Picked for Pediatrics and Child Health (top studies of the week, 27 September 2026): Remimazolam reduces emergence delirium after tonsillectomy
  • Picked for Anesthesiology and Pain Medicine (paper of the day, 27 September 2026): Remimazolam bolus reduced emergence delirium

Abstract

Background/Objectives: Emergence delirium (ED) is common after sevoflurane anesthesia in children undergoing otolaryngologic surgery. Remimazolam is an ultra-short-acting benzodiazepine that may reduce ED without delaying recovery. This study evaluated the effect of a single remimazolam bolus administered at the end of surgery on ED in children undergoing tonsillectomy and/or adenoidectomy. Methods: In this prospective, randomized, triple-blind, placebo-controlled trial, 110 children aged 3-9 years with American Society of Anesthesiologists physical status I received remimazolam 0.1 mg/kg (n = 57) or an equal volume of normal saline (n = 53) immediately after discontinuation of sevoflurane and before extubation. The primary outcome was ED at extubation, defined as a Pediatric Anesthesia Emergence Delirium (PAED) score ≥ 10. Secondary outcomes included Face, Legs, Activity, Cry, and Consolability (FLACC) scores, emergence time, early recovery, postoperative vomiting, and airway complications. Results: ED occurred in 1 of 57 children (1.8%) receiving remimazolam and in 11 of 53 children (20.8%) receiving placebo (p = 0.002). The absolute risk reduction was 19.0% (95% confidence interval [CI], 7.5-31.8), the relative risk was 0.08 (95% CI, 0.01-0.63), and the number needed to treat was 6. The overall distribution of FLACC scores at extubation differed between groups (p = 0.047), with FLACC scores of 0 occurring more frequently in the remimazolam group. Median emergence time was 10 min in both groups, and all children achieved a modified Aldrete score > 8 within 15 min. Postoperative vomiting was assessed through 30 min; the comparison at 5 min showed no significant between-group difference. Airway complications also did not differ significantly between groups. Conclusions: A single intravenous bolus of remimazolam 0.1 mg/kg administered at the end of surgery significantly reduced PAED-defined ED without prolonging emergence or delaying early postoperative recovery.

Abstract as published, via PubMed.

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For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.