Does intranasal dexmedetomidine provide adequate plasma concentrations for sedation in children: a pharmacokinetic study

Miller, Jeffrey W.; Balyan, Rajiv; Dong, Min; Mahmoud, Mohamed; Lam, Jennifer E.; Pratap, Jayant Nick; Paquin, Joanna Rosing; Li, B.L.; Spaeth, James P.; Vinks, Alexander A.; Loepke, Andreas W.

doi:10.1016/j.bja.2018.01.035

Cited by 76 publications

(75 citation statements)

References 38 publications

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“…but lower than those after intramuscular and intravenous administration . According to the literature, the bioavailability of intranasally administered DEX is sufficient to warrant further investigation, and the median absolute bioavailability of intranasally administered DEX was reported to be 83.8% (69.5%‐98.1%) in children. We performed intranasal administration by nasal dropping, which is more convenient and quicker than the atomization method.…”

Section: Discussioncontrasting

confidence: 86%

“…The intranasal route is an effective and quite comfortable way to administer DEX, especially in children with a fear of needles, and this route may be superior to intravenous or intramuscular administration. The plasma concentrations after intranasal administration were higher than plasma concentrations after oral and buccal administration . but lower than those after intramuscular and intravenous administration .…”

Section: Discussionmentioning

confidence: 92%

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Determination of the 90% effective dose of intranasal dexmedetomidine for sedation during electroencephalography in children

Liu

Sun

Zhang

et al. 2019

Acta Anaesthesiol Scand

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EEG is a valuable diagnostic tool for children with epilepsy, delirium and other central nervous system lesions. Children likely experience difficulty falling asleep when they are scheduled to undergo EEG. Therefore, sedation is very important.Sedation for EEG in uncooperative children remains controversial because most anaesthetics and sedatives have some effect on brain waves. Many sedative medications, such as chloral hydrate, hydroxyzine and dexmedetomidine (DEX), have been used in children undergoing EEG. Chloral hydrate is a commonly used sedative in EEG. However, previous studies have shown that chloral hydrate for sedation has a high failure rate of 27% in patients with abnormal behaviour, 1,2 it may increase fast EEG activity, and it has side effects, including respiratory depression, 3 apnoea, airway obstruction, hypoxia, hypotension and hypercarbia. 4 DEX is a highly selective alpha-2 adrenergic agonist that functions as a sedative and an analgesic. DEX has been studied as a suitable sedative agent for children undergoing many procedures, as it has a low risk of side effects and a short half-life. DEX can cause EEG patterns similar to those of sleep stage II with modest increases in θ, α and β activity and has no effect on EEG epileptic activity in children, which makes it a suitable Background: The intranasal route of dexmedetomidine (DEX) administration is becoming increasingly popular for providing adequate sedation during short examinations in infants and children. However, data on the 90% effective dose (ED90) of intranasal DEX are rare in children under 3 years old.Methods: This is a double-blind trial using a biased coin design up-and-down sequential method (BCD-UDM). Fifty-three children aged under 3 years old requiring DEX for EEG were included in our study. The first patient received 2.5 μg kg −1 DEX, and the dose of DEX administered to the subsequent patient was determined by the response of the previous patient. The patient responses were recorded and analysed to calculate the ED90 by isotonic regression. The 95% confidence interval (CI) was estimated using a bootstrapping method.Results: Fifty-three patients were included in our study, of which 45 patients were successfully sedated, and the 8 instances of failed sedation were rescued using sevoflurane inhalation, allowing the completion of the procedure. The 90% effective dose of DEX was calculated to be 3.28 µg kg −1 , and the 95% CI was 2.74 ~ 3.39 µg kg −1 .No significant adverse events occurred in any of the patients. Conclusion:The 90% effective dose of intranasal DEX sedation for EEG was 3.28 μg kg −1 in children under 3 years old.

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Section: Discussioncontrasting

confidence: 86%

Section: Discussionmentioning

confidence: 92%

Determination of the 90% effective dose of intranasal dexmedetomidine for sedation during electroencephalography in children

Liu

Sun

Zhang

et al. 2019

Acta Anaesthesiol Scand

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“…The bioavailability of intranasal dexmedetomidine using an atomizer has been reported to be 83.8% in children. 21 Furthermore, the mucosal atomization device used in this study delivers an atomized solution to the nasal mucosa that results in rapid absorption of the drug directly into the systemic circulation. Intranasal administration offers the potential of a less invasive and convenient approach to anesthetic premedication in children.…”

Section: Discussionmentioning

confidence: 99%

<p>Ketamine Enhances Intranasal Dexmedetomidine-Induced Sedation in Children: A Randomized, Double-Blind Trial</p>

Zheng¹,

Shi²,

Chen³

et al. 2020

DDDT

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Purpose: To compare the efficacy of intranasal dexmedetomidine and dexmedetomidineketamine premedication in preschool children undergoing tonsillectomy. Patients and Methods: We enrolled 66 children with American Society of Anesthesiologists physical status I or II, aged 3-7 years undergoing tonsillectomy. Patients were randomly allocated to receive intranasal premedication with either dexmedetomidine 2 μg kg −1 (Group D) or dexmedetomidine 2 μg kg −1 and ketamine 2 mg kg −1 (Group DK). The primary outcome was the sedation level assessed by the Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) 30 min after intervention. The minimal clinically relevant difference in the MOAA/S score was 0.5. Secondary outcomes included sedation onset time, parental separation anxiety, acceptance of mask induction, emergence time, emergence delirium, postoperative pain intensity, length of stay in the post-anesthesia care unit (PACU), and adverse effects. Results: At 30 min after premedication, the MOAA/S score was lower in Group DK than in Group D patients (median: 1.0, interquartile range [IQR]: 1.0-2.0 vs median: 3.0, IQR: 2.0-3.0; P<0.001), with a median difference of 1.0 (95% confidence interval [CI]: 1.0-2.0, P<0.001). Patients in Group DK showed considerably faster onset of sedation (15 min, 95% CI: 14.2-15.8 min) than Group D (24 min, 95% CI: 23.2-24.8 min), with a median difference of 8.0 min (95% CI: 7.0-9.0 min, P<0.001). Both parental separation and facemask acceptance scores were lower in Group DK than in Group D patients (P=0.012 and P=0.001, respectively). There was no significant difference in emergence time, incidence of emergence delirium, postoperative pain scores, and length of stay in the PACU between the two groups. Conclusion: Intranasal premedication with a combination of dexmedetomidine and ketamine produced better sedation for pediatric tonsillectomy than dexmedetomidine alone.

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“…As animal studies have shown, drugs can be administered through the nasal cavity, which can effectively reduce first-pass elimination, and the drug can more efficiently enter the brain through the nervous olfactory system [8]. The overall bioavailability of DEX in children with intranasal administration was reported to be 84% [9]. The use of DEX alone in paediatric sedation provides adequate sedation [10,11].…”

Section: Introductionmentioning

confidence: 99%

Intranasal dexmedetomidine is an effective sedative agent for electroencephalography in children

Chen

Yang

et al. 2020

BMC Anesthesiol

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Background: Intranasal dexmedetomidine (DEX), as a novel sedation method, has been used in many clinical examinations of infants and children. However, the safety and efficacy of this method for electroencephalography (EEG) in children is limited. In this study, we performed a large-scale clinical case analysis of patients who received this sedation method. The purpose of this study was to evaluate the safety and efficacy of intranasal DEX for sedation in children during EEG. Methods: This was a retrospective study. The inclusion criteria were children who underwent EEG from October 2016 to October 2018 at the Children's Hospital affiliated with Chongqing Medical University. All the children received 2.5 μg•kg − 1 of intranasal DEX for sedation during the procedure. We used the Modified Observer Assessment of Alertness/Sedation Scale (MOAA/S) and the Modified Aldrete score (MAS) to evaluate the effects of the treatment on sedation and resuscitation. The sex, age, weight, American Society of Anesthesiologists physical status (ASAPS), vital signs, sedation onset and recovery times, sedation success rate, and adverse patient events were recorded. Results: A total of 3475 cases were collected and analysed in this study. The success rate of the initial dose was 87.0% (3024/3475 cases), and the success rate of intranasal sedation rescue was 60.8% (274/451 cases). The median sedation onset time was 19 mins (IQR: 17-22 min), and the sedation recovery time was 41 mins (IQR: 36-47 min). The total incidence of adverse events was 0.95% (33/3475 cases), and no serious adverse events occurred. Conclusions: Intranasal DEX (2.5 μg•kg − 1) can be safely and effectively used for EEG sedation in children.

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Does intranasal dexmedetomidine provide adequate plasma concentrations for sedation in children: a pharmacokinetic study

Cited by 76 publications

References 38 publications

Determination of the 90% effective dose of intranasal dexmedetomidine for sedation during electroencephalography in children

Determination of the 90% effective dose of intranasal dexmedetomidine for sedation during electroencephalography in children

<p>Ketamine Enhances Intranasal Dexmedetomidine-Induced Sedation in Children: A Randomized, Double-Blind Trial</p>

Intranasal dexmedetomidine is an effective sedative agent for electroencephalography in children

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