ArticleJournal of intensive care2023
Efficacy, safety, and pharmacokinetics of MR13A11A, a generic of remifentanil, for pain management of Japanese patients in the intensive care unit: a double-blinded, fentanyl-controlled, randomized, non-inferiority phase 3 study.
Article in Journal of intensive care, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 10 citations in OpenAlex.
- Pharmacokinetics of Opioid Infusions in the Adult Intensive Care Unit Setting-A Systematic Review.Clinical pharmacokinetics · 2025Pooled it
- ICU patients receiving remifentanil do not experience reduced duration of mechanical ventilation: a systematic review of randomized controlled trials and network meta-analyses based on Bayesian theories.Frontiers in medicine · 2024Pooled it
- Short-term light sedation with remimazolam besylate versus propofol in the ICU (SHOSREB): a multicentre, randomized, single-blind, controlled trial.Intensive care medicine · 2026Trial
- Feasibility and safety of an analgesia-first strategy without hypnotic sedatives in adult patients admitted to the intensive care unit after neurosurgical craniotomy: a protocol for a single-arm, single-center exploratory prospective study.Frontiers in medicine · 2026Article
- Efficacy and safety of sivelestat sodium hydrate adjunct to remifentanil for analgesia in patients under mechanical ventilation (SIDING trial): protocol of a multicenter, randomized, double-blinded, placebo-controlled trial.Frontiers in medicine · 2026Article
- Implementing Evidence-Based, Phase-Specific Multimodal Analgesia for Total Joint Arthroplasty: An Interprofessional Review for Nursing Practice and Management.Journal of nursing management · 2026Review
- Article
- Comparative efficacy of remifentanil and fentanyl in mechanically ventilated ICU patients: a systematic review and meta-analysis on ventilation duration and delirium incidence.Journal of anesthesia, analgesia and critical care · 2025Article
- Remifentanil vs. dexmedetomidine for cardiac surgery patients with noninvasive ventilation intolerance: a multicenter randomized controlled trial.Journal of intensive care · 2024Article
- Remifentanil use in intensive care units: Current evidence and future perspectives.Acute medicine & surgeryReview
- Response to "Remifentanil-Induced Chest Wall Rigidity in an Infant With Hepatic Failure".Acute medicine & surgeryArticle
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe aims of this study were to evaluate the efficacy, safety, and pharmacokinetics (PK) of continuous intravenous administration of remifentanil in mechanically ventilated patients in the intensive care unit (ICU).
methodsThis was a multicenter, randomized, double-blinded, fentanyl-controlled, non-inferiority phase 3 study. Patients aged ≥ 20 years requiring 6 h to 10 days mechanical ventilation in an ICU and requiring pain relief were randomly assigned in a 1:1 ratio to receive either remifentanil (n = 98) or fentanyl (n = 98). Dose was titrated from an infusion rate of 1 mL/h (remifentanil: 0.025 µg/kg/min, fentanyl: 0.1 µg/kg/h) until the target level of analgesia (behavioral pain scale [BPS] ≤ 5 or numerical rating score [NRS] ≤ 3) was achieved by escalating the dose in 1 mL/h increasing. Administration was then adjusted to maintain the target level of analgesia until weaning from the ventilator. The primary endpoint was the proportion of patients who did not require rescue fentanyl. Safety was assessed according to standard procedures. PK of remifentanil in the arterial blood was assessed in 24 patients.
resultsThe proportion of patients achieving the primary endpoint in the remifentanil and fentanyl groups was 100% (92/92) and 97.8% (88/90), respectively. The difference between the groups was 2.2% (95% confidence interval, - 0.8-5.3) and non-inferiority of remifentanil to fentanyl was verified (p < 0.0001). The incidences of any adverse events in the remifentanil and fentanyl groups was 34 of 92 patients (37.0%) and 34 of 90 patients (37.8%), respectively. Adverse drug reactions was 12 in 92 patients (13.0%) and 15 in 90 patients (16.7%), respectively. In the PK analysis, blood remifentanil concentration decreased within 10 min to almost 50% of the end of administration, suggesting rapid offset of action following discontinuation of remifentanil.
conclusionsRemifentanil can be used safely for pain management in mechanically ventilated Japanese patients in the ICU.
trial registrationJapan Registry of Clinical Trials, jRCT2080224954. Registered 20 November 2019, https://jrct.niph.go.jp/latest-detail/jRCT2080224954 .
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