Trial reportBMC pediatrics2026
Efficacy and safety of HR020602 in combination with propofol in children receiving general anesthesia: a multicenter, phase 2 study.
Trial report in BMC pediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04867343 (Pharmacokinetics, Safety and Efficacy of HR020602 Injection in Children Undergoing General Anesthesia), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Pharmacokinetics, Safety and Efficacy of HR020602 Injection in Children Undergoing General Anesthesia
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
Abstract
backgroundThe objective of this study was to evaluate the efficacy and safety of esketamine hydrochloride injection (HR020602) in combination with propofol for the induction and maintenance of general anesthesia in children, providing additional support for the use of esketamine in pediatric patients.
methodsThis phase 2 study (NCT04867343) was conducted in two stages. Stage 1 involved the evaluation of the optimal dosing, and stage 2 was a multicenter, randomized, double-blind, positive control study to evaluate the efficacy and safety of HR020602, on the basis of the dose recommended in stage 1. The primary endpoint was the success rate of anesthesia induction in stage 2.
resultsIn total, 70 children were enrolled (20 children in stage 1 and 50 children in stage 2). The recommended dose was 1.0 mg/kg in stage 1. In stage 2, 50 children were randomized (1:1) to the HR020602 group (n = 24) or the fentanyl group (n = 26). Demographics and baseline characteristics were balanced between groups. In stage 2, the primary endpoint, the induction success rate, was 100.0% in both the HR020602 group and the fentanyl group, whereas the maintenance success rate was lower in the HR020602 group (62.5% vs. 92.3%). In stage 2, treatment-related adverse events (TRAEs) occurred in 91.7% of the children in the HR020602 group and 61.5% in the fentanyl group. No serious TRAEs or deaths were reported.
conclusionCompared with fentanyl-based anesthesia, HR020602 at a dosage of 1.0 mg/kg, when coadministered with propofol, achieved reliable induction but was associated with a lower maintenance success rate. Further studies on dose optimization and alternative strategies are warranted.
trial registrationThe study was registered at ClinicalTrials.gov (NCT04867343) on April 30, 2021.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.