Combined use of intranasal Dexmedetomidine and an oral novel formulation of Midazolam for sedation of young children during brain MRI examination: a prospective, single-center, randomized controlled trial

Abstract

Background To evaluate the safety and effectiveness of different dosages of intranasal Dexmedetomidine (DEX) in combination with oral midazolam for sedation of young children during brain MRI examination. Methods Included in this prospective single-blind randomized controlled trial were 156 children aged from 3 months to 6 years and weighing from 4 to 20 Kg with ASA I-II who underwent brain MRI examination between March 2021 and February 2022. Using the random number table method, they were divided into group A (using 3 ug/kg intranasal DEX plus 0.2 mg/Kg oral midazolam) and group B (using 2 ug/kg intranasal DEX plus 0.2 mg/Kg oral Midazolam). The one-time success rate of sedation, sedation onset time, recovery time, overall sedation time, and occurrence of adverse reactions during MRI examination were compared between the two groups. The heart rate (HR), mean arterial pressure (MAP), and percutaneous SpO2before and after drug administration were observed in both groups. Differences in sedation scores between the two groups were compared before intranasal drug administration (T0), 10 min after drug administration (T1), at the time of falling asleep (T2), at the end of examination (T3), and at the time of recovery (T4). Results The one-time success rate of sedation in group A and B was 88.31% and 79.75% respectively, showing no significant difference between the two groups (P>0.05). The sedation onset time in group A was 24.97±16.94 min versus 27.92±15.83 min in group B, and the recovery time was 61.88±22.18 min versus 61.16±28.16 min, both showing no significance difference between the two groups (P>0.05). Children in both groups exhibited good drug tolerance without presenting nausea and vomiting, hypoxia, or bradycardia and hypotension that needed clinical interventions. There was no significant difference in the occurrence of abnormal HR, MAP or other adverse reactions between the two groups (P>0.05). Conclusion 3 ug/kg or 2 ug/kg intranasal DEX in combination with 0.2 mg/kg oral Midazolam both are safe and effective for sedation of children undergoing MRI examination with the advantages of fast-acting and easy application. Trial registration It was registered at the Chinese Clinical Trial Registry (ChiCTR1800015038) on 02/03/2018.

Combination of Intranasal Dexmedetomidine and Midazolam for Sedation in Pediatric Magnetic Resonance Imaging

“…Recently, Gu et al 21 published a prospective single-center single-blind randomized controlled trial comparing 2 doses of dexmedetomidine 3 μg/kg versus 2 μg/kg intranasal associated with oral midazolam 0.2 mg/kg, the latter similar to ours for patients weighing more than 40 kg.…”

Efficacy of intranasal administration of dexmedetomidine in combination with midazolam for sedation in infant with cleft lip and palate: A double blinded prospective randomized trial

“…Undoubtedly, the e cacy of using some sedatives in combination with dexmedetomidine is better. A study by Gu H et al revealed that oral midazolam (0.2 mg/kg) with intranasal dexmedetomidine (2-3 µg/kg) might produce an excellent sedative effect for children undergoing MRI [14]. However, considering the younger age in our study, we opted to administer midazolam intranasally rather than orally because coughing and irritation may result in uncooperativeness.…”

Efficacy of intranasal administration of dexmedetomidine in combination with midazolam for sedation in infant with cleft lip and palate undergoing CT scan: a randomized controlled trial

“…Undoubtedly, the efficacy of using some sedatives in combination with dexmedetomidine is better. A study by Gu H et al revealed that oral midazolam (0.2 mg/kg) with intranasal dexmedetomidine (2–3 μg/kg) might produce an excellent sedative effect for children undergoing MRI [ 14 ]. However, considering the younger age in our study, we opted to administer midazolam intranasally rather than orally because coughing and irritation may result in uncooperativeness.…”

“…Considering the disadvantages of midazolam and dexmedetomidine, some studies have reported the combination of the two sedatives to optimize the sedative effect. However, these studies involved the administration of dexmedetomidine intranasally plus midazolam orally [ 13 , 14 ]. In addition, this type of combination was more suitable for older children than younger children because younger children tend to be uncooperative when on an oral medication, which can cause irritation and coughing.…”

“…However, the use of sedative in combination for children with cleft lip and palate was rare. Given that many studies focused on the use of sedatives in combination by multiple routes and older pediatric population for imaging procedures [ 8 , 13 , 14 ]. The concern in this study was the use of non-invasive intranasal sedatives in combination for younger infants with cleft lip and palate.…”