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Background: This prospective, randomized, double-blind trial was done to compare intranasal dexmedetomidine and intranasal midazolam as premedication for sedation and ease of child-parent separation in pediatric patients of tetralogy of Fallot (TOF) undergoing corrective cardiac surgery. Materials and Methods: Forty children with TOF, between 1 and 10 years, undergoing corrective cardiac surgery were included in the study and, after randomization, were given intranasal midazolam (0.2 mg/kg) or intranasal dexmedetomidine (1 µg/kg), 30 min before shifting to the operation room (OR). Patients were assessed for sedation and child-parent separation, along with hemodynamic parameters, respiratory rate, and oxygen saturation (SpO2) 30 min after drug administration, at the time of shifting inside the OR, and at the time of induction of anesthesia. Results: Both groups had comparable child-parent scores, hemodynamic parameters, SpO2, and respiratory rate. However, the dexmedetomidine group had significantly better sedation levels than the midazolam group patients at the time of shifting inside the OR (dexmedetomidine group: 3.55 ± 0.82 vs. midazolam group: 2.80 ± 0.83; P = 0.007) and at the time of induction of anesthesia (dexmedetomidine group: 3.40 ± 0.75 vs. midazolam group: 2.70 ± 0.86; P = 0.009). Conclusion: Intranasal dexmedetomidine provides better sedation than midazolam, with similar child-parent separation scores and hemodynamic parameters, respiratory rate, and SpO2. No adverse events were observed in both groups. A study on a larger population will help in further establishing the safety and superiority of dexmedetomidine and will further its regular use as an intranasal premedication.

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Aim: To compare the safety and efficacy of intranasal high-dose dexmedetomidine (DEX) versus a combination of intranasal low-dose dexmedetomidine and oral chloral hydrate (DEX-CH) sedation during electroencephalography (EEG) in children. Methods: Unadjusted analysis, 1:1 propensity score matching (PSM), and inverse probability of treatment weighting (IPTW) were used to compare the sedation success rate, adverse effects, onset time, and recovery time of these two sedation methods for 6967 children who underwent EEG. Results: A total of 6967 children were enrolled in this study, of whom 846 (12.1 %) underwent DEX intranasal sedation while 6121 (87.9 %) received DEX-CH sedation. No significant differences were observed in the sedation success rate with the first dose between the two groups [824 (97.4 %) for DEX vs. 5971 (97.6 %) for DEX-CH; RR 0.99; 95 % CI, 0.98-1.01; P = 0.79]. Similarly, there were no notable disparities in the incidence of adverse events [16 (1.9 %) for DEX vs. 101 (1.7 %) for DEX-CH; RR 1.15; 95 % CI, 0.68-1.93; P = 0.32]. However, intranasal DEX sedation compared with DEX-CH sedation was associated with lower vomiting [0 vs. 95(1.6 %); RR 0.04; 95 % CI, 0.02-0.6; P = 0.02] or more bradycardia [13(1.5 %) vs. 2(0.03 %); RR 47.03; 95 % CI, 10.63-208.04; P < 0.001]. Multivariate analysis using PSM and IPTW analysis yielded similar results. Conclusion: Both methods for EEG had high sedation success rate and low incidence of adverse events. High-dose intranasal DEX was more likely to induce bradycardia and had a shorter recovery time than the DEX-CH sedation, which was more likely to induce vomiting.

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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).

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OBJECTIVE: This study aimed to evaluate the safety and feasibility of intranasal administration of dexmedetomidine as a premedication for preventing hypotension and hypothermia in canine patients undergoing MRI examinations. ANIMALS: Dogs undergoing MRI examinations for neurological disorders were enrolled in this study. The dogs were randomly assigned: 15 to the N-Dex group (without premedication) and 13 to the Dex group (125 µg/m2 of dexmedetomidine, intranasally, as a premedication). METHODS: During the examination, pulse rate, systolic blood pressure, diastolic blood pressure, and mean arterial blood pressure were recorded every 5 minutes for the first 30 minutes. Body temperature was measured before and after the examination. Any adverse events during the procedure were documented. RESULTS: Significant changes in pulse rate during the examination were not distinguishable. Although blood pressure and body temperature decreased in both groups under anesthesia, dogs in the Dex group had a significantly smaller drop in blood pressure and body temperature and fewer hypotension events than those in the N-Dex group MRI examinations of 1 hour's duration. Two dogs in the Dex group exhibited bradycardia at 45 and 60 minutes of MRI examination, which resolved after receiving atipamezole. CLINICAL RELEVANCE: Our results indicate that intranasal administration of 125 µg/m2 of dexmedetomidine as premedication is safe and can potentially mitigate hypothermia and hypotension in dogs with neurological disorders during MRI examinations.

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Purpose: Sevoflurane is the preferred anesthetic agent for induction and maintenance of ambulatory surgery due to its property of fast onset and recovery. However, it has been recognized as one of the major contributors of emergence delirium. The aim of this study was to evaluate the preventive effect of intranasal dexmedetomidine on the occurrence of emergence delirium in pediatric patients under general anesthesia with sevoflurane. Patients and Methods: Ninety pediatric patients undergoing dental rehabilitation under sevoflurane anesthesia were enrolled in this study. The patients were divided into three groups (n=30 each in the 2 µg/kg dexmedetomidine, 1 µg/kg dexmedetomidine, and control with saline groups). The same volume (0.02mL/kg) of the mixed solution was dropped into the nasal cavity of the children 30 minutes before surgery. We used the Pediatric Anesthesia Emergence Delirium Scale (PAED) to assess the level and incidence of delirium in the post-anesthesia care unit. Results: Compared with the control group, prophylactic use of different dosages of intranasal dexmedetomidine significantly reduces the incidence of ED and severe ED in PACU (P<0.001). Intranasal administration of 2 µg/kg dexmedetomidine was associated with a better acceptance of mask induction and a better tolerance of separation with parents. Conclusion: Both 2 µg/kg and 1 µg/kg intranasal dexmedetomidine can achieve ED preventive effects in PACU in dental rehabilitation under general anesthesia. A dosage of 2 µg/kg is more effective in preventing severe ED and providing better mask acceptance.

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Background and aims MRI sedation in paediatrics includes challenges like respiratory depression, maintaining haemodynamic stability and use of neuroprotective drugs, since MRI is performed in remote places outside the operating room with a lack of support staff and nonavailability of choice of medications and equipments. The primary aim was to use a combination of the drugs to encounter the above challenges and look for its efficacy. The secondary aim of the study was to determine the rate of successful completion of MRI in children using a combination of intranasal dexmedetomidine and intravenous midazolam - without the need for rescue sedatives. Methods This is an observational study involving 60 children in the age group between two months and six years undergoing an MRI. Children belonging to the American Society of Anesthesiology (ASA) 1 and 2 were given intranasal dexmedetomidine 3µg/kg, time to onset of sedation was noted and injection of midazolam 0.1 mg/kg was given intravenously. MRI was started once the child was asleep. Children who woke up during the MRI were supplemented with inj. propofol 0.5-1mg/kg and were documented. Results The median time duration for MRI was 38.7 min and the onset of sedation after intranasal dexmedetomidine was 18.7 min. The scan was successfully completed with a combination of intranasal dexmedetomidine and intravenous midazolam in 86.7% and only 13.3% of the children woke up either at the start or in between the scan and required the addition of propofol. Conclusion Drugs used for sedation during MRI should not cause respiratory depression and be safe for the developing brain. The above study has shown that a combination of intranasal dexmedetomidine and intravenous midazolam is effective and safe in performing MRIs in paediatrics.

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BACKGROUND: We know that syndromic conditions and severe chronic diseases can be associated with symptoms that may interfere with sleep, significantly impacting the life quality of children and caregivers. Drugs commonly used in treating insomnia, such as melatonin, benzodiazepines, niaprazine, and antihistamines, are often either ineffective or associated with adverse effects, requiring new therapeutic perspectives. Dexmedetomidine is a selective alpha-2 agonist with hypnotic and anxiolytic effects, which, by stimulating alpha-2 adrenergic receptors in the locus coeruleus, induces sleep comparable to stages 2-3 of the non-REM phase without substantially affecting the respiratory drive during sedation. Its use has already been extensively described in pediatric intensive care or procedural sedation literature. In 2018, the Italian Medicines Agency (Agenzia Italiana Del Farmaco AIFA) authorized the off-label use of dexmedetomidine outside of intensive care in Children undergoing palliative treatment to control distressing symptoms related to pathology and refractory sleep disorders, and the literature reported cases of children who received dexmedetomidine at home. OBJECTIVE: Our study aims to describe the home use of dexmedetomidine in children with insomnia or intractable dystonic states. MEASURES: We conducted a retrospective analysis through a questionnaire addressed to 12 Italian pediatric palliative care centers regarding the home use of dexmedetomidine in sleep disorders and intractable dystonic states. INTERVENTION: We collected a case series of 9 children treated with dexmedetomidine at home, 8 via intranasal and 1 via intravenous route. All children received the first drug administration in the hospital or hospice during a dedicated admission, under close monitoring of vital signs parameters for 72 hours (3 days, range 2-7 days). After discharge, the potential side effects of the drug were explained to the patient's families, and, once informed consent was obtained, the home administration of dexmedetomidine continued, with follow-up by the palliative care team. At home, dexmedetomidine was administered for 3000 days (minimum 1 month, maximum 36 months). The first patient was treated for 1095 days, from 2019 to 2021 (discontinued due to underlying condition-related death). OUTCOMES: All patients observed a persistent benefit from the treatment on symptoms, and none of them discontinued dexmedetomidine administration due to drug-related adverse effects or perceived lack of therapeutic efficacy. CONCLUSIONS: Therefore, its use at home may represent a promising therapeutic approach for intractable sleep disorders or dystonic states in pediatric palliative care children. Further studies are needed to confirm our results.

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OBJECTIVES: We investigated the efficacy and complication profile of intranasal dexmedetomidine for transthoracic echocardiography sedation in patients with single ventricle physiology and shunt-dependent pulmonary blood flow during the high-risk interstage period. METHODS: A single-centre, retrospective review identified interstage infants who received dexmedetomidine for echocardiography sedation. Baseline and procedural vitals were reported. Significant adverse events related to sedation were defined as an escalation in care or need for any additional/increased inotropic support to maintain pre-procedural haemodynamics. Minor adverse events were defined as changes from baseline haemodynamics that resolved without intervention. To assess whether sedation was adequate, echocardiogram reports were reviewed for completeness. RESULTS: From September to December 2020, five interstage patients (age 29-69 days) were sedated with 3 mcg/kg intranasal dexmedetomidine. The median sedation onset time and duration time was 24 minutes (range 12-43 minutes) and 60 minutes (range 33-60 minutes), respectively. Sedation was deemed adequate in all patients as complete echocardiograms were accomplished without a rescue dose. When compared to baseline, three (60%) patients had a >10% reduction in heart rate, one (20%) patient had a >10% reduction in oxygen saturations, and one (20%) patient had a >30% decrease in blood pressure. Amongst all patients, no significant complications occurred and haemodynamic changes from baseline did not result in need for intervention or interruption of study. CONCLUSIONS: Intranasal dexmedetomidine may be a reasonable option for echocardiography sedation in infants with shunt-dependent single ventricle heart disease, and further investigation is warranted to ensure efficacy and safety in an outpatient setting.

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Background and Objective: Several patients with pre-operative anxiety and insomnia refuse to take sleeping pills because of the side effects of sleeping pills. This study aimed to evaluate the applicability of intranasal dexmedetomidine (DEX) in the treatment of pre-operative anxiety and insomnia. Methods: A total of 72 patients with insomnia and anxiety were randomly divided into two groups of intranasal DEX (n = 36) and intranasal normal saline (NS, n = 36). The primary outcomes included patients' time to fall asleep, total sleep time, insomnia severity index (ISI) after treatment, and satisfaction with the treatment effect. The secondary outcomes were mean arterial pressure (MAP), oxygen saturation (SPO2), heart rate (HR), Narcotrend index (NI) in the first 2 h of treatment, and the incidence of adverse events within 12 h after treatment. Results: The time to fall asleep (22.08 ± 3.95 min) and total sleep time (400.06 ± 28.84 min) in the DEX group were significantly different from those in the NS group [time to fall asleep, 89.31 ± 54.56 min; total sleep time (295.19 ± 73.51 min; P < 0.001)]. ISI after treatment in the DEX group was lower than that in the NS group (P < 0.001). Satisfaction with the treatment effect was better in the DEX group than that in the NS group (P < 0.001). The general vital signs in the two groups were stable during the treatment. The drowsiness rate in the NS group was higher than that in the DEX group (P < 0.001). Conclusion: Intranasal DEX can significantly improve pre-operative anxiety and insomnia. Clinical Trial Registration: This study was registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn/searchproj.aspx, ChiCTR2100044747).

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Background: This systematic review was undertaken to compare the benefits of intranasal dexmedetomidine (IND) versus oral chloral hydrate (OCH) in the pediatric age group undergoing procedural sedation analgesia (PSA). Randomized clinical trials (RCT) of the various studies done over the years were taken up and analyzed. Since IND has the additional advantages of a faster onset of action, greater success with a single bolus dose, and enhanced recovery, this systematic review was conducted to prove the superiority of IND over OCH in pediatric PSA. Objective: To compare the efficacy of IND versus OCH for PSA in pediatric patients. Search Strategy: We searched the electronic databases from August 2012 to September 2019 without language restrictions. Design and Selection Criteria: A review of 10 RCTs on the use of IND and OCH for PSA in the pediatric age group for a variety of diagnostic procedures was done and the superiority of IND as per the sedation time and adverse effects were analyzed. Results: Out of the RCTs considered, six trials were a direct comparison between OCH and IND which showed that IND had a faster onset of action, improved recovery characteristics with better return to baseline physical activity on the same day of the procedure. When compared to OCH, IND showed no evidence of second-dose requirement and no record of postoperative nausea and vomiting (PONV). Conclusion: This systematic review revealed that IND is superior to OCH for PSA in the pediatric age group and proved to be safe and effective with better recovery characteristics.

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BACKGROUND: Intranasal dexmedetomidine (IN DEX) is a relatively new sedative agent with supporting evidence on its efficacy and safety, which can be used for procedural sedation in children, and could have a major role in auditory brainstem response testing, especially in the case of non-cooperative children. The goal of this systematic review is to assess the role of IN DEX in ABR testing, evaluating the reported protocol, potential, and limits. METHODS: We performed a comprehensive search strategy on PubMed, Scopus, and Google Scholar, including studies in English on the pediatric population, without time restrictions. RESULTS: Six articles, published between 2016 and 2021, were included in the systematic review. Sedation effectiveness was high across the studies, except for one study; 3 µg/kg was the dosing most often used. A comparison group was present in three studies, with oral chloral hydrate as the drug of comparison. Adverse effects were rarely reported. CONCLUSION: This systematic review showed how IN DEX can represent an adequate sedative for children undergoing ABR testing; larger and more rigorous trials are warranted in order to recommend its systematic utilization.

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BACKGROUND: Non-painful diagnostic procedures require an inactive state for a prolonged time, so that sedation is often needed in younger children to perform the procedures. Our standard of care in this setting consists of the association between oral midazolam (0.5 mg/kg) and intranasal dexmedetomidine (4 mcg/kg). One of the limits of this approach is that the onset of action is quite delayed (up to 55 min) and poorly predictable. We chose to compare this association with intranasal-ketamine and intranasal-dexmedetomidine. METHODS: This is a "pre-post" study. The study population included the first forty children receiving sedation with the "new" combination intranasal ketamine (3 mg/kg) and intranasal dexmedetomidine (4 mcg/kg) compared to a historical cohort including the last forty children receiving sedation with our standard of care combination of intranasal dexmedetomidine (4mcg/kg) and oral midazolam (0,5 mg/kg). RESULTS: The association intranasal dexmedetomidine and intranasal ketamine allowed for a significantly shorter sedation induction time than the combination intranasal dexmedetomidine and oral midazolam (13,5 min versus 35 min). Both group's cumulative data showed a correlation between age and sedation effectiveness, with younger children presenting a higher success rate and shorter induction time (p 0,001). CONCLUSIONS: This study suggests that the ketamine and dexmedetomidine intranasal association may have a shorter onset of action when compared to intranasal dexmedetomidine and oral midazolam.

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Background: Nebulized dexmedetomidine has been used for procedural sedation and allaying separation anxiety in children. Literature regarding its use in the attenuation of laryngoscopy and intubation response via the nebulized route is scarce. We evaluated preoperative dexmedetomidine nebulization on the hemodynamic response arising from laryngoscopy/intubation, hemodynamics, analgesic consumption, and postoperative sore throat. Objectives: The primary objective was to evaluate/compare the hemodynamic effects of preoperative intravenous and nebulized dexmedetomidine on laryngoscopy/intubation and compare the efficacy of the two routes in blunting the sympathoadrenal response. The secondary objective was to evaluate their effects on intraoperative analgesic consumption and incidence and sore throat postoperatively. Methods: 120 ASA I & II adult patients undergoing elective surgeries requiring tracheal intubation were randomized to receive intravenous dexmedetomidine (1 µg/kg over 10 minutes) and nebulized dexmedetomidine (1 µg/kg in 3 - 4 mL of 0.9% saline), 30 min before anesthesia induction. Heart rate and non-invasive blood pressure were monitored for 10 min following laryngoscopy and then throughout the surgery. Intraoperative analgesic consumption, postoperative sore throat, and recovery from anesthesia were assessed. Results: No significant hemodynamic difference was found between the two groups till three minutes. Then, the difference turned significant owing to a greater fall in the heart rate and mean arterial pressure in the intravenous group. Nebulized dexmedetomidine exhibited a lesser tendency of hypo/hypertension and brady/tachycardia, while hemodynamics was more stable. There was lesser sore throat and sedation in the nebulized group. Intraoperative analgesic and propofol consumption was comparable between the two groups. Conclusions: Nebulized dexmedetomidine attenuated laryngoscopy and intubation response, although to a lesser extent than the intravenous group in equivalent doses. However, the nebulized route provided greater hemodynamic stability in the intraoperative period and lesser sedation/sore throat postoperatively without an increase in adverse effects. Nebulized dexmedetomidine may provide a more holistic and viable alternative in patients who poorly tolerate hypotension, bradycardia, and sedation.

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Background: Procedural sedation required to improve the quality of Transthoracic Echocardiography (TTE) in infants and children. The ideal drug and route for sedation in children should have a rapid and reliable onset, atraumatic, palatable with minimal side effects, and rapid recovery. So, the aim of our study to evaluate and compare the efficacy and safety of intranasal midazolam and intranasal dexmedetomidine in pediatric patients for sedation during TTE. Materials and Method: Hundred children under three year of age, belonging to the American Society of Anaesthesiologists class-I and II, scheduled for TTE were divided into two groups by standard randomization technique. Patients in group-M received intranasal midazolam 0.2 mg/kg, whereas patients in group-D received intranasal dexmedetomidine 2 µg/kg prior to TTE under an adequately monitored anesthesia care. Onset and duration of sedation, heart rate, oxygen saturation, sonographer's, and parent's satisfaction scores were recorded. Results: All patients were successfully sedated for TTE. The average onset time, sedation time, awakening time and total time for Group-M were 7.3, 18.8, 29.51, 51 min and group-D were 10.1, 14.2, 24.9, 46.3 min, respectively and all were statistically significant (P < 0.001). TTE scan time of Group-M is 8.84 min and Group-D is 9.18 min and was statistically significant. Sonographer's and Parent's average satisfaction score for Group-M was 9.88, 10 and for Group-D was 7.64, 8.76, respectively, which were statistically significant (P < 0.001). Conclusion: Intranasal midazolam and dexmedetomidine are safe and effective for sedation in TTE. Intranasal midazolam was found to be comparatively more effective in view of onset of action, sonographers, and parental satisfaction score, while sedation time, awakening time and total duration was significantly higher as compared to intranasal dexmedetomidine.

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OBJECTIVES: We report a case series of one-time 4 mcg/kg dose of intranasal dexmedetomidine and 1 mcg/kg of intranasal fentanyl plus inhaled nitrous oxide for procedural sedation in children with otitis media with effusion (OME) for tympanostomy tube placement with a specific handheld device (Solo TTD, AventaMed ®). METHODS: A retrospective review was conducted in a tertiary paediatric teaching hospital on patients with OME referred from December 2018 to December 2019 in need of procedural sedation for myringotomy and ventilation tube insertion (VTI). Sixteen of twenty-four consecutively admitted subjects received a one-time dose (4 mcg/kg) of intranasal dexmedetomidine and 1mcg/Kg of intranasal fentanyl followed by inhaled nitrous oxide (iN2O) at 50% with the intended goal to achieve a Ramsay Sedation Score 4 allowing a motionless procedure with adequate analgesia. Parents' satisfaction for the procedure was measured by mean of a Likert scale (from 0 to 5 points). RESULTS: Sixteen patients underwent procedural sedation for myringotomy with VTI. Sedation was achieved successfully in fifteen patients (93,75%), with a mean induction time of 29 min (range 19-43) and a mean recovery time of 74 min (range 54-110). The patient who did reach an adequate sedation level underwent an intravenous line positioning and a dose of ketamine. No adverse effects were reported, and the parents' judgment average on the Likert scale was 4,93. VTI procedure was successful in all ears. CONCLUSIONS: A combination of intranasal dexmedetomidine, fentanyl, and iN2O could be considered as a possible option for procedural sedation in children with OME undergoing procedural sedation for tympanostomy tube placement in children with Solo TTD device.

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Sleep disturbance is a crucial issue in pediatric palliative care, with a dramatic impact on the quality of life of children and families. Dexmedetomidine (DEX) is a selective α-2 agonist, with anxiolytic, hypnotic, and analgesic properties, that could play a role in the management of refractory sleep disturbances. We describe the use of intranasal DEX as a sleep inductor in a 10-year-old female with dystrophic epidermolysis bullosa and a severe sleep disorder. After treatment with melatonin, benzodiazepines, and niaprazine had failed, she was admitted to the hospital where 3 mcg/kg/day of intranasal DEX was administered before bedtime. She received 0.7 mL of the IV formulation at a concentration of 100 mcg/mL with half the dose given in each nostril via a Mucosal Atomization Device. During this time, she was also monitored for potential side effects (e.g., bradycardia, blood pressure derangements). After 2 weeks of hospitalization, she was discharged with ready-to-use doses of DEX for home treatment. The child's heart rate and blood oxygen saturation were monitored at home. There was a definite improvement in sleep quality and duration, daytime alertness, pain control, and quality of life. No side effects were reported and the drug retained its effect over time (the patient is currently taking the drug). Intranasal DEX could be a safe and effective strategy to manage refractory sleep disturbances in children in pediatric palliative care.

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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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STUDY OBJECTIVE: Intranasal dexmedetomidine (DEX) can provide adequate sedation during short examinations in children. However, we found no data regarding the 95% effective dose (ED95) of intranasal DEX for children's pulmonary function testing (PFT). DESIGN: Prospective study and a biased coin design up-and-down sequential method. SETTING: Sedation center of Children's Hospital of Chongqing Medical University. PATIENTS: Children aged 1-3 years undergoing pulmonary function testing. INTERVENTION: The dose of DEX for each subsequent patient was determined by the response of the previous patient with the biased coin design up-and-down sequential method with an interval of 0.25 µg∙kg-1. MEASUREMENTS: Children aged 1-3 years who received pulmonary function testing were involved in this dose-finding trial. Intranasal DEX started at a dose of 2 µg∙kg-1 on the first patient. The dose of DEX for each subsequent patient was determined by the response of the previous patient with the biased coin design up-and-down sequential method with an interval of 0.25 µg∙kg-1. The sedation was assessed by the Modified Observer Assessment of Alertness and Sedation (MOAA/S) scale, and recovery was assessed by the modified Aldrete recovery score. The ED95 was calculated using isotonic regression. Other variables, including the sedation onset time, examination time, wake-up time, blood pressure (BP), heart rate (HR), respiratory rate (RR), and oxyhaemoglobin desaturation (SpO2), were recorded. Adverse events such as hypotension, bradycardia, respiration depression, oxyhaemoglobin desaturation, regurgitation and vomiting were recorded. MAIN RESULTS: A total of 68 children were enrolled for the study; 62 children had successful sedation, and 6 had failed sedation. The ED95 of intranasal DEX was estimated to be 2.64 µg∙kg-1 [95% confidence interval (CI), 2.49-2.87 µg∙kg-1]. The sedation onset time for all patients was 15.0 (12.3-19.0) min. The sedation onset time of successful sedation patients was 15.0 (12.0-19.0) min, the sedation onset time of failed sedation patients was 16.0 (15.0-27.8) min, the examination time was 8 (7-10) min, and the wake-up time was 40 (35-43) min. There were no adverse events during the whole procedure. CONCLUSION: The ED95 of intranasal DEX sedation in children aged 1-3 years undergoing PFT was 2.64 µg∙kg-1.

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BACKGROUND: Dexmedetomidine is widely used for non-invasive pediatric procedural sedation. However, the hemodynamic effects of intravenous dexmedetomidine are a concern. There has been a growing interest in the application of intranasal dexmedetomidine as a sedative in children. OBJECTIVE: To investigate the incidence of bradycardia in children undergoing intranasal dexmedetomidine sedation and to identify the associated risk factors. METHODS: Data pertaining to pediatric patients who underwent intranasal dexmedetomidine sedation for non-invasive investigations at the Kunming Children's Hospital between October 2017 and August 2018 were retrospectively analyzed. RESULTS: Out of 9984 children who qualified for inclusion, 228 children (2.3%) developed bradycardia. The incidence of bradycardia in the group that received additional dose of dexmedetomidine was higher than that in the group that did not receive additional dose (9.2% vs 16.7%; P = .003). The incidence of bradycardia in males was higher than that in females (2.6% vs 1.8%; P = .007). On multivariate logistic regression, only male gender showed an independent association with the occurrence of bradycardia (odds ratio 1.48; 95% confidence interval 1.11-1.97; P = .008). CONCLUSIONS: The overall incidence of bradycardia in children after sole use of intranasal dexmedetomidine sedation was 2.3%. Male children showed a 1.48-fold higher risk of bradycardia. However, the blood pressure of the children who developed bradycardia was within the normal range. Simple wake-up can effectively manage bradycardia induced by intranasal dexmedetomidine sedation.

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Dexmedetomidine is an α2 adrenoreceptor agonist that may be administered by the intranasal route as a sole sedative agent in children. It is odourless, colourless and tasteless and is formulated in a concentration of 100µg.ml-1. We performed a review of published randomised controlled trials in order to determine the efficacy of intranasal dexmedetomidine for sedation in children. Fourteen trials were eligible for inclusion in the review and contained a total of 1809 patients ranging in age from one month to 14 years. Intranasal dexmedetomidine was administered in a dose range of 1-4µg.kg-1 and was compared with various other sedatives. Dexmedetomidine was administered by either drops or a mucosal atomiser device. The procedures ranged from non-painful examinations such as magnetic resonance imaging scans and transthoracic echocardiography to painful procedures such as dentistry and venous cannulation. Administration of 2µg.kg-1 appears to be the optimal dose.

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