Combined sedation in pediatric magnetic resonance imaging: determination of median effective dose of intranasal dexmedetomidine combined with oral midazolam.

BACKGROUND: The exact median effective dose (ED50) of intranasal dexmedetomidine combined with oral midazolam sedation for magnetic resonance imaging (MRI) examination in children remains unknow and the aim of this study was to determine the ED50 of their combination. METHODS: This is a prospective dose-finding study. A total of 53 children aged from 2 months to 6 years scheduled for MRI examination from February 2023 to April 2023 were randomly divided into group D (to determine the ED50 of intranasal dexmedetomidine) and group M (to determine the ED50 of oral midazolam). The dosage of dexmedetomidine and midazolam was adjusted according to the modified Dixon's up-and-down method, and the ED50 was calculated with a probit regression approach. RESULTS: The ED50 of intranasal dexmedetomidine when combined with 0.5 mg∙kg- 1 oral midazolam was 0.39 µg∙kg- 1 [95% confidence interval (CI) 0.30 to 0.46 µg∙kg- 1] while the ED50 of oral midazolam was 0.17 mg∙kg- 1 (95% CI 0.01 to 0.29 mg∙kg- 1) when combined with 1 µg∙kg- 1 intranasal dexmedetomidine. The sedation onset time of children with successful sedation in group D was longer than in group M (30.0[25.0, 38.0]vs 19.5[15.0, 35.0] min, P < 0.05). No other adverse effects were observed in the day and 24 h after medication except one dysphoria. CONCLUSION: This drug combination sedation regimen appears suitable for children scheduled for MRI examinations, offering a more precise approach to guide the clinical use of sedative drugs in children. TRIAL REGISTRATION: Chinese Clinical Trial Registry, identifier: ChiCTR2300068611(24/02/2023).

The effect of age on outpatient pediatric procedural sedation with intranasal dexmedetomidine and oral midazolam.

Procedural sedation for diagnostic examination is a common practice in children. The study aims to analyze the sedative effect and safety of intranasal dexmedetomidine combined with oral midazolam in outpatient pediatric procedural sedation across different age groups and to assess the incidence of sedation failure. From February 2021 to September 2021, children who underwent procedural sedation were retrospectively enrolled. The children were divided into 4 groups based on age: the infant group (0 to 1 year old), toddler group (1 to 3 years old), preschool group (3 to 6 years old), and school-age group (6 to 12 years old). Two-mcg/kg intranasal dexmedetomidine and 0.5-mg/kg oral midazolam were used for sedation. The sedation success rate after rescue, sedation success rate, onset time of sedation, and the sedation time were recorded. The incidence of adverse events and the risk factors for sedation failure were also analyzed. A total of 4758 patients were identified. After exclusion, 3149 patients were ultimately enrolled. The combination of 2-mcg/kg intranasal dexmedetomidine and 0.5-mg/kg oral midazolam resulted in a total success rate of 99.7% and a sedation success rate of 91.4%. The sedation success rate varied among the four groups: 90.2% in the infant group, 93.1% in the toddler group, 92.7% in the preschool group, and 78.4% in the school-age group. The sedation success rate was significantly lower in the school-age group compared to the other three groups (P < 0.001). The onset time of sedation was shorter in infant (22 min, IQR: 18-28 min, P < 0.001) and longer in the school-age group (30 min, IQR: 25-35 min, P < 0.05). Additionally, the infants had a longer sedation time (110 min, IQR: 90-135 min, P < 0.001) and a higher rate of delayed recovery (27.5%, all P < 0.001). The incidence of adverse events was low (4.70%), which bradycardia (2.03%) being the most common. Age (0-1 year and > 6 years), weight, ASA class II, and history of failed sedation were identified as risk factors of sedation failure.   Conclusion: Intranasal administration of 2-mcg/kg dexmedetomidine combined with oral administration of 0.5-mg/kg midazolam was found to be efficient and safety for pediatric procedural sedation. Different age groups of children exhibited distinct sedation characteristics, and age was identified as a risk factor affecting the efficacy of sedation. What is Known: • Procedural sedation for diagnostic examination is a common practice in children. • The combination of dexmedetomidine with midazolam can improve sedative effects. What is New: • The success rate of sedation using a combination of 2-mcg/kg intranasal dexmedetomidine and 0.5-mg/kg oral midazolam was significantly lower in school-age children as compared to infants, toddlers, and preschoolers. • The onset time of sedation increased with age, and the sedation time was found to be longer in infant patients.

Impact of intravenous administration of nalbuphine at different time points for postoperative analgesia and sedation in adenotonsillectomized children: a prospective, randomized controlled trial.

Objective: To compare the efficacy of intravenous administration of nalbuphine at different time points for postoperative analgesia and sedation in adenotonsillectomized children. Methods: Patients with obstructive sleep apnea syndrome scheduled for adenotonsillectomy were randomly divided into group A (patients received intravenous nalbuphine 0.2 mg/kg before anesthesia induction), group B (patients received intravenous nalbuphine 0.2 mg/kg 10 min before the end of surgery), and group C (patients did not receive nalbuphine injection). The time points for measuring outcomes were before anesthesia induction (T0), extubation (T1), and 0, 15, 30, or 45 min in the postanesthesia care unit (PACU) (T2-T5, respectively). Results: There were 40 patients in group A, 41 patients in group B and 39 patients in group C. Patients in group B had significantly lower FLACC (Face, Legs, Activity, Cry, Consolability) pain scores at T2-T5 than those in group C (all p<0.05). Patients in group B had higher Ramsay Sedation Score at T2-T4 than those in group C (all p<0.05). The proportion of patients who received remedial analgesia in the PACU in group A (17.5%, p=0.008) and group B (9.8%, p<0.001) was significantly lower than that in group C (46.2%). Conclusion: Intravenous administration of nalbuphine 10 min before the end of adenotonsillectomy in children could decrease pain intensity and increase sedation levels during the recovery period with the reduction of remedial analgesia in the PACU.Trial registration number ChiCTR2200060118.

Clinical Effect and Safety Analysis of 2.5 µg/kg DEX Nasal Drop in Child Undergoing Ultrasound Examination.

In order to meta-analyze the clinical effect and safety of dexmedetomidine (DEX) intranasal sedation in child ultrasound examination, literature retrieval is carried out in Wanfang Medicine, PubMed database, domestic medical research journals. The relevant medical information literature on clinical effects and safety are analyzed by using Rev Man 5.2 software. The retrieved literature is screened according to the research object, method, disease type and other criteria. The results of meta-analysis show that dexmedetomidine intranasal sedation is applied to child undergoing ultrasound examination, and the SPO2 and sedation time are significantly higher than those in the conventional sedation group (P < 0.05). The time/score is significantly lower than that in the conventional sedation group (P < 0.05), and the incidence of adverse reactions in the dexmedetomidine intranasal sedation group is significantly lower than that in the conventional sedation group (P < 0.05).