Trial reportDrug design, development and therapy2026
Comparison of the Effective Dose 90 (ED90) and Clinical Outcomes of Fentanyl Versus Esketamine for Analgesia in Hysteroscopy: A Two-Part, Randomized, Double-Blind Trial.
Trial report in Drug design, development and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Hysteroscopy is a minimally invasive procedure that can nonetheless elicit considerable pain, especially during cervical dilation. While fentanyl is widely used for analgesia, its application is limited by side effects such as respiratory depression. Esketamine, a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, has emerged as a promising alternative due to its potent analgesic effects and safer profile. This study aimed to determine and compare the effective dose 90 (ED90) of these drugs for preventing physical movements and to evaluate their efficacy and safety. Methods: This two-part, prospective, randomized, double-blind trial enrolled patients scheduled for hysteroscopy. In Part 1, the ED90 of intravenous fentanyl (0.25-2.00 μg/kg) and esketamine (0.15-0.50 mg/kg) was determined using a sequential allocation biased-coin design (SABCD). The SABCD was implemented independently for each drug, with a targeted enrollment of 60 participants per group; ultimately, 56 participants per group were included in this dose-finding phase. In Part 2, clinical outcomes and adverse events were compared in an additional set of 56 patients per group, all of whom received the predetermined ED90 of their assigned drug. Results: The ED90 of fentanyl was 1.424 μg/kg (95% confidence interval [CI]: 1.322-1.618 μg/kg), compared to 0.423 mg/kg (95% CI: 0.368-0.569 mg/kg) for esketamine. The two groups exhibited comparable efficacy in physical movements inhibition and total propofol consumption. However, the esketamine group demonstrated a markedly improved safety and recovery profile. Specifically, patients receiving esketamine reported significantly less propofol injection pain (fentanyl group vs esketamine group, 25% vs 7.1%; relative risk [RR], 0.4; 95% CI: 0.2-0.8; Conclusion: At equipotent ED90 doses, esketamine provides analgesia equivalent to fentanyl during hysteroscopy, while conferring additional advantages, such as reduced injection pain, faster emergence, superior cardiorespiratory stability, and potential psychological benefits. Registration: Chinese Clinical Trial Registry ChiCTR2500106429.
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