Jin QQ, Cai WC, Zhou YF, Zhang YT, Chen G, Xu MT, Li J, Yuan KM. Comparison of a ready-to-use intranasal dexmedetomidine spray with traditional intranasal dexmedetomidine drops for sedation in preschool children: a prospective, randomized, controlled study. Front Pharmacol. 2025 Jan 23;16:1528612. doi: 10.3389/fphar.2025.1528612. PMID: 39917619; PMCID: PMC11799867.
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Abstract
Purpose: This study compared the efficacy and acceptability of a ready-to-use intranasal dexmedetomidine spray (DS) versus traditional drops administered by syringe (DD) in pediatric patients undergoing elective surgery.
Patients and methods: Eighty-six preschool children were enrolled in a prospective, randomized, controlled study. Children were randomly assigned to receive either DS or DD. For children weighing between 10.5 and 18.5 kg, a dexmedetomidine dosage of 30 μg (two sprays) was administered, while those weighing between 18.5 and 25.5 kg received 45 μg (three sprays). In the DD group, dexmedetomidine was administered at a dose of 2 μg/kg based on body weight. The primary outcome was the proportion of children achieving a Ramsay sedation scale (RSS) score of ≥3 within 30 min. Secondary outcomes included acceptance of intranasal medication, anxiety at parental separation and prior to induction, and compliance with induction.
Results: A total of 83 cases were analyzed. The proportion of children achieving an RSS score of ≥3 within 30 min was similar between the DS and DD groups (90.7% vs. 77.5%, respectively). However, the acceptance score was significantly better in the DS group (mean difference [95%]: -0.9 [-1.267 to -0.5325], P < 0.001). No significant differences were observed between the groups in terms of successful child-parent separation (88.4% vs. 85%) or satisfactory anxiolytic effect prior to induction (95.3% vs. 92.5%). Compliance with induction was comparable, with 53.5% in the DS group and 40.0% in the DD group demonstrating “optimal” compliance.
Conclusion: Both intranasal spray and syringe drop methods were highly effective in providing sedation and anxiolysis, but the ready-to-use intranasal dexmedetomidine spray was more acceptable to children, offering a viable alternative to the syringe method.
Clinical trial registration: ChiCTR.org.cn, identifier ChiCTR2400089374.
Banga P, Negi SL, Mandal B, Barwad P, Saini K, Gourav KP. Comparative Evaluation of Regain of Consciousness in Dexmedetomidine-Propofol versus Ketamine-Propofol in the Pediatric Cardiac Catheterization Procedure under Sedation using BIS Monitoring: A Randomized Prospective Study. Ann Card Anaesth. 2025 Jan 1;28(1):33-38. doi: 10.4103/aca.aca_19_24. Epub 2025 Jan 24. PMID: 39851148.
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Abstract
Background: Congenital heart diseases (CHDs) are not rare and often require an intervention at some point of time. Pediatric cardiac catheterization, a minimally invasive procedure, is performed to diagnose and to correct many cardiac abnormalities. Deep sedation with spontaneously breathing patients is the preferred technique for pediatric catheterization in the pediatric population. Therefore, the author aimed to find the best combination of drugs for pediatric cardiac catheterization procedures using dexmedetomidine-propofol (DP) and ketamine-propofol (KP).
Materials and methods: Cyanotic and acyanotic CHD children, weighing 5-20 kg and undergoing sedation for cardiac catheterization, were randomly assigned into two groups. DP group children received a bolus intravenous (IV) propofol at 1 mg/kg body weight followed by 1 mcg/kg dexmedetomidine over 10 minutes. KP group children received a bolus IV propofol 1 mg/kg followed by ketamine 1 mg/kg over 10 minutes. For maintenance in the DP group, propofol infusion at 1.5 to 2 mg/kg/h and dexmedetomidine at 0.5 mcg/kg/h was started. In the KP group, propofol infusion at 1.5 to 2 mg/kg/h and ketamine at 1 mg/kg/h was started as maintenance. The bispectral index (BIS) was monitored throughout the procedure, and the BIS value was maintained between 60 and 80. Propofol top of 1 mg/kg was administered when the BIS value became more than 80 or when the child moved during the femoral vessel puncture or when the child moved during the procedure.
Results: The mean time for regain of consciousness was faster (P < 0.005) in the KP group (11.02 ± 11.98) compared to the DP group (21.62 ± 18.68). BIS was monitored throughout the procedure; BIS values were lower (P < 0.001) in the DP group (60.0 ± 11.1) as compared to the KP group (73.7 ± 5.6). The cumulative doses of propofol in the KP group and DP group were comparable. Total fentanyl consumptions in the intraoperative period in the KP group and DP group were comparable (P > 0.001). There was no difference in drug side effects between the groups.
Conclusion: The KP combination had fast and early recovery compared to the DP combination in children who underwent the cardiac catheterization procedure under sedation in children undergoing cardiac catheterization procedures requiring sedation.
Pei D, Xiao T, Zeng L, Wei S, Wang L, Du Z, Qu S. Optimal doses of intranasal esketamine plus dexmedetomidine for sedating toddlers during transthoracic echocardiography: a prospective, double-blind, randomized trial. Ann Med. 2025 Dec;57(1):2453087. doi: 10.1080/07853890.2025.2453087. Epub 2025 Jan 17. PMID: 39822073; PMCID: PMC11749271.
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Abstract
Introduction: Esketamine has unique advantages in combination with dexmedetomidine for sedation in young children, owing to its sympathetic activity and mild respiratory depression. However, the optimal dose is yet to be determined. In this study, we compared the different doses of intranasal esketamine combined with dexmedetomidine for sedation during transthoracic echocardiography in toddlers.
Patients and methods: A total of 121 eligible children aged 13 years, who were scheduled for transthoracic echocardiography were randomized into three groups. They were treated with intranasal dexmedetomidine 1 mcg.kg-1 + esketamine 0.5 mg.kg-1 (group S1), dexmedetomidine 1 mcg.kg-1 + esketamine 1 mg.kg-1 (group S2), or dexmedetomidine 1 mcg.kg-1 + esketamine 1.5 mg.kg-1 (group S3). The primary outcome was the success rate of sedation, other outcomes included HR, SpO2, onset time, wake-up time, and adverse effects.
Results: The success rate of sedation was significantly higher in groups S2 (85.4%) and S3 (87.5%) than ingroup S1 (60%) (p = 0.004). The baseline HR and SpO2 did not differ between the groups at the corresponding time points following drug administration. The onset time and duration of sedation in group S1 were significantly longer than those in groups S2 and S3 (p = 0.000). However, there were no differences in the wake-up time or adverse effects among the three groups.
Conclusions: Intranasal administration of 1 mg.kg-1 esketamine combined with 1 mcg.kg-1 dexmedetomidine provided satisfactory sedation in young children undergoing transthoracic echocardiography. This sedative approach offers a rapid onset of awakening with few side effects.
Clinical trial registration number: ChiCTR2200060976, 2022/06/14 (trail from August 2022 to January 2023).
Chakravarty R, Goyal N, Kumar R, Mohammed S, Kamal M, Chhabra S, Bhatia P. Comparison of effects of dexmedetomidine with ketofol and ketofol alone on quality of sedation in pediatric patients undergoing magnetic resonance imaging: A prospective randomized controlled double-blind trial. Saudi J Anaesth. 2024 Oct-Dec;18(4):521-527. doi: 10.4103/sja.sja_327_24. Epub 2024 Oct 2. PMID: 39600442; PMCID: PMC11587956.
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Abstract
Background and aim: Patient movement during magnetic resonance imaging (MRI) is the most frequent cause of artifacts and poor scan quality. Children cannot lie still. Thus, anesthesia is required to keep the child calm and immobile. This randomized double-blinded clinical trial compares the clinical effects of the addition of dexmedetomidine as premedication with ketofol on the quality of sedation. We hypothesized that the addition of dexmedetomidine would improve the quality of sedation.
Methods: A total of 132 children aged 6 months to 10 years were randomized into groups DK (dexmedetomidine-ketofol) and K (ketofol). DK received an intravenous bolus of dexmedetomidine (0.5 mcg/kg) as premedication 10 minutes prior. Both the groups were induced with ketofol (0.5 mg/kg), and sedation was maintained with propfol infusion (100 mcg/kg/min). The primary objective was the quality of sedation as assessed by the University of Michigan Sedation Scale. Image quality, requirement of rescue propofol dose, recovery, and adverse events were also studied. Data are given as median [interquartile range (IQR)] or frequency.
Results: All 132 children completed MRI scans. The DK group showed significantly better quality of sedation, 71% versus 47% of children, a median difference of 1 (-0.569 to -0.0969), P < .005, a better quality of scan, a reduced number of additional doses of propofol, and a decreased total dose of propofol. Hemodynamic parameters and recovery times for the two groups were similar. There were no significant side effects in both groups.
Conclusion: The quality of sedation and the quality of the MRI scan are greatly improved by administering dexmedetomidine (0.5 mcg/kg) 10 minutes before to induction. Additionally, this technique decreases the need of propofol and gives better hemodynamic stability without delaying the recovery time.
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