University Of Michigan Sedation Scale Research Articles

A non-randomized controlled study of total intravenous anesthesia regimens for magnetic resonance imaging studies in children.

Background and Aims:We studied the efficacy and safety of different total intravenous anesthesia used for pediatric magnetic resonance imaging (MRI).Material and Methods:Children of 1–7 years age (n = 88), undergoing MRI received a loading dose of dexmedetomidine 1 μg/kg over 10 min, ketamine 1 mg/kg, and propofol 1 mg/kg in sequence. University of Michigan Sedation Scale (UMSS) of 3 was considered an acceptable level for starting the scan. Rescue ketamine 0.25–0.5 mg/kg was given if UMSS remained <3. After the loading dose of drugs, some children attained UMSS = 4 or progressive decline in heart rate, therefore, did not receive any infusion. The rest received either dexmedetomidine (0.7 μg/kg/h) (n = 35) or propofol (3 mg/kg/h) (n = 38) infusion for maintenance. Ketamine 0.25 mg/kg was used as rescue. Sedation failure was considered if either there was inability to complete the scan at the pre-set infusion rate, or there was need for >3 ketamine boluses or serious adverse events occurred. Statistical Package for Social Sciences 20 was used for analysis.Results:Initiation of scan was 100% successful with median induction time of 10 min. Maintenance of sedation was successful in 100% with dexmedetomidine and 97.4% with propofol infusion. Recovery time (25 min v/s 30 min), discharge time (35 min v/s 60 min), and total care duration (80 min v/s 105 min) were significantly less with propofol as compared to dexmedetomidine (P = 0.002, 0.000, and 0.000, respectively). There were no significant adverse events observed.Conclusion:Dexmedetomidine 1μg/kg, ketamine 1 mg/kg, and propofol 1 mg/kg provide good conditions for initiation of MRI. Although dexmedetomidine at 0.7μg/kg/h and propofol at 3 mg/kg/h are safe and effective for maintenance, propofol provides faster recovery.

Role of intranasal midazolam as a procedural sedative in children aged 6 months to 12 years: An open-label randomized controlled study

Objectives: The objectives of the study were to evaluate the efficacy and the adverse effects of intranasal midazolam compared to intravenous (IV) midazolam for procedural sedation in children between 6 months and 12 years of age using the University of Michigan sedation scale. Design: Prospective open-label randomized controlled trial. Setting: Children requiring sedation for any invasive or non-invasive procedure in the Department of Paediatrics, between June 2012 and May 2014. Participants: A total of 246 children aged between 6 months and 12 years of age were enrolled and sequentially allocated into the study by computer-generated block randomization. Intervention: As per randomization, participants were administered intranasal or IV midazolam before the procedure. Procedure was done 5 min after IV and 15 min after intranasal administration. Main outcome measures: Sedation score was rated using the University of Michigan Sedation Score. The ease of performance, numbers of successfully completed procedures, and adverse effects were noted. Results: Intranasal midazolam provided better sedation scores (p&lt;0.001) and ease of procedure scores (p=0.026) compared to IV, especially in the age group from 6 months to 6 years. Both groups gave comparable successful procedure completion rates. The most commonly encountered side effect with intranasal was nasal irritation (p&lt;0.001). Conclusion: Intranasal midazolam provided significantly better sedation and ease of procedure scores when compared to IV, with fewer adverse effects. Hence, it can be put to use in resource-limited settings.

278 Intranasal Ketamine for Procedural Sedation in Children: A Randomized Controlled Pilot Study

The pain of intravenous (IV) insertion is rated by children as second only to disease-related pain. Procedural sedation and analgesia (PSA) is a common indication for IV insertion in the emergency department (ED). Ketamine is the most frequently used agent for PSA in children. Intranasal ketamine (INK) has shown effectiveness for PSA in a limited number of painful procedures (IV insertion, gastric aspiration, and laceration repair) but no studies have explored INK for fracture reduction in children. Our objective was to evaluate the feasibility of INK for PSA in children who sustained a fracture requiring a closed reduction. This was a randomized, blinded, controlled, trial comparing the effectiveness of INK versus intravenous ketamine (IVK). We included children 4-17 years, < 40 kg with a non-shortened distal forearm fracture requiring PSA for closed reduction. Participants were randomized using a double-dummy approach to receive single dose (i) INK 8 mg/kg (maximum 320 mg) + 0.9% IV normal saline OR (ii) IVK 1 mg/kg (maximum of 40 mg) + IN 0.9% normal saline. The primary outcome was the proportion of participants with adequate sedation during closed reduction as defined by a University of Michigan Sedation Scale (UMSS) score of > 3 of 4. Secondary outcomes included need for additional IV sedation, adverse effects, time to sedation defined as a UMSS score of > 3 of 4, and length of stay. Fifteen participants were consecutively recruited from March 1, 2016 to Feb 1, 2017. Seven children (3 females) received INK and the mean (SD) age was 6.6 (3.1) years. Eight children (3 females) received IVK and the mean (SD) age was 5.9 (2) years. Adequate sedation was achieved by 4/7 (57.1%) versus 7/8 (87.5%) participants in the INK and IVK groups, respectively (p = 0.28). The median (IQR) time to sedation was 10 (11.3) versus 5 (0) minutes in the INK and IVK groups, respectively (p = 0.23). Additional IVK was required by 5/7 (71.4%) versus 2/8 (25%) of participants in the INK and IVK groups, respectively (p = 0.13). Adverse effects consisting of nausea, vomiting, or dizziness were seen in 4/7 (57.1) versus 2/8 (25%) of participants in the INK and IVK groups, respectively (p = 0.32). No participants experienced emergence agitation and there were no serious adverse events. The median (IQR) length of stay in the INK and IVK groups was 364 (153) versus 290 (113) minutes, respectively (p = 0.13). The adequacy of sedation for INK 8 mg/kg is inconsistent for closed reduction of distal forearm fractures in children. Greater sedative efficacy may be achieved with a higher INK dose (9-10 mg/kg), consistent with demonstrated effectiveness in other studies of PSA in children undergoing painful procedures.

Optimal Volume of Administration of Intranasal Midazolam in Children: A Randomized Clinical Trial

The optimal intranasal volume of administration for achieving timely and effective sedation in children is unclear. We aimed to compare clinical outcomes relevant to procedural sedation associated with using escalating volumes of administration to administer intranasal midazolam. We conducted a randomized, single-blinded, 3-arm, superiority clinical trial. Children aged 1 to 7 years and undergoing laceration repair requiring 0.5 mg/kg intranasal midazolam (5 mg/mL) were block-randomized to receive midazolam using 1 of 3 volumes of administration: 0.2, 0.5, or 1 mL. Procedures were videotaped, with outcome assessors blinded to volume of administration. Primary outcome was time to onset of minimal sedation (ie, score of 1 on the University of Michigan Sedation Scale). Secondary outcomes included procedural distress, time to procedure start, deepest level of sedation achieved, adverse events, and clinician and caregiver satisfaction. Ninety-nine children were enrolled; 96 were analyzed for the primary outcome and secondary outcomes, except for the outcome of procedural distress, for which only 90 were analyzed. Time to onset of minimal sedation for each escalating volume of administration was 4.7 minutes (95% confidence interval [CI] 3.8 to 5.4 minutes), 4.3 minutes (95% CI 3.9 to 4.9 minutes), and 5.2 minutes (95% CI 4.6 to 7.0 minutes), respectively. There were no differences in secondary outcomes except for clinician satisfaction with ease of administration: fewer clinicians were satisfied when using a volume of administration of 0.2 mL. There was a slightly shorter time to onset of minimal sedation when a volume of administration of 0.5 mL was used compared with 1 mL, but all 3 volumes of administration produced comparable clinical outcomes. Fewer clinicians were satisfied with ease of administration with a volume of administration of 0.2 mL.

Validity of the Richmond Agitation-Sedation Scale (RASS) in critically ill children

BackgroundThe Richmond Agitation-Sedation Scale (RASS) is a single tool that is intuitive, is easy to use, and includes both agitation and sedation. The RASS has never been formally validated for pediatric populations. The objective of this study was to assess inter-rater agreement and criterion validity of the RASS in critically ill children.MethodsTo evaluate validity, the RASS score was compared to both a visual analog scale (VAS) scored by the patient’s nurse, and the University of Michigan Sedation Scale (UMSS), performed by a researcher. The nurse completed the VAS by drawing a single line on a 10-cm scale anchored by “unresponsive” and “combative.” The UMSS was used to validate the sedation portion of the RASS only, as it does not include grades of agitation. For inter-rater agreement, one researcher and the patient’s nurse simultaneously but independently scored the RASS.ResultsOne hundred patient encounters were obtained from 50 unique patients, ages 2 months to 21 years. Of these, 27 assessments were on children who were mechanically ventilated and 73 were on children who were spontaneously breathing. In validity testing, the RASS was highly correlated with the nurse’s VAS (Spearman correlation coefficient 0.810, p < .0001) and with the UMSS (weighted kappa 0.902, p < .0001). Inter-rater agreement between nurse- and researcher-assessed RASS was excellent, with weighted kappa of 0.825 (p < .0001).ConclusionsThe RASS is a valid responsiveness tool for use in critically ill children. It allows for accurate assessment of awareness in mechanically ventilated and spontaneously breathing patients, and may improve our ability to titrate sedatives and assess for delirium in pediatrics.

The Fan Study: Intranasal Fentanyl and Inhaled Nitrous Oxide for Fracture Reduction

Abstract BACKGROUND: Recently, intranasal (IN) fentanyl and inhaled nitrous oxide/oxygen (N2O) mixture have been increasingly used for procedural sedation and analgesia (PSA) alone or in combination. There is a lack of data on the efficacy of these combined agents. OBJECTIVES: To evaluate the efficacy of IN fentanyl and N2O as PSA for the reduction of mildly-to-moderately displaced fractures and dislocations. DESIGN/METHODS: We performed a prospective, observational cohort study between September 2014 and October 2015. Patients were recruited at CHU Sainte Justine (Montréal, Canada) and Royal Children Hospital (Melbourne, Australia). Patients between the age of 4 and 18 years were eligible if PSA consisted of IN fentanyl and N2O for the reduction of mildly-to-moderately displaced fractures or dislocations. Patients received at least IN fentanyl 1.5 mcg/kg (100 mcg max) and at least a 50/50% mixture of N2O with oxygen. Primary outcome was the efficacy of PSA measured by the patient assigned Facial Pain Scale-Revised (FPS-R). The Face, Legs, Activity, Cry, Consolability (FLACC) scale was also recorded. Depth of sedation was evalu-ated using the University of Michigan Sedation Scale (UMSS). Adverse events were recorded following the criteria of the Consensus Panel on Sedation Research of PERC/PECARN. Additional data concerning satisfaction or discomfort were evaluated via questionnaires, and follow-up telephone calls were made to elicit information on adverse events after discharge. RESULTS: A total of 91 patients aged 9.7±3.0 years were enrolled. There was no difference between the median FPS-R score during the procedure compared to before: Median 2 and 2 (median difference 0 [95% CI 0, 0]), respectively. The FLACC score was higher during the procedure than before: Median 4 and 0 (median difference 2 [95% CI 1, 3]). UMSS was 1 (95% CI 1, 2) during the procedure. 42 (46%) patients had adverse events, all mild: vertigo (20%), nausea (16%)]or vomiting (12%). A total of 85/88 (97%) parents and 82/85 (96%) ED physicians would want the same sedation in another procedure. CONCLUSION: PSA with IN fentanyl and N2O seems effective in our cohort study, as evaluated by patient assigned FPS-R. Patients were minimally sedated. Adverse events were frequent but mild. Overall, parents and medical staff would want the same agents used in another procedure. Thus, PSA with IN fentanyl and N2O appears to be an attractive option for reduction of mildly displaced fractures or dislocations.

P030: The FAN study: intranasal fentanyl and inhaled nitrous oxide for fracture reduction

Introduction: Recently, intranasal (IN) fentanyl and inhaled nitrous oxide/oxygen (N2O) mixture have been increasingly used for procedural sedation and analgesia (PSA) alone or in combination. There is a lack of data on the efficacy of these combined agents. Methods: The objective was to evaluate the efficacy of IN fentanyl and N2O as PSA for the reduction of mildly-to-moderately displaced fractures and dislocations. We performed a prospective, observational cohort study between September 2014 and October 2015. Patients were recruited at CHU Sainte Justine (Montréal) and Royal Children Hospital (Melbourne, Australia). Patients aged 4 to 18 years were eligible if PSA consisted of IN fentanyl and N2O for the reduction of mildly-to-moderately displaced fractures or dislocations. Patients received at least IN fentanyl 1.5 mcg/kg (100 mcg max) and at least a 50/50% mixture of N2O with oxygen. Primary outcome was the efficacy of PSA measured by the patient assigned Facial Pain Scale-Revised (FPS-R). The Face, Legs, Activity, Cry, Consolability (FLACC) scale was also recorded. Depth of sedation was evaluated using University of Michigan Sedation Scale (UMSS). Adverse events were recorded following criteria of the Consensus Panel on Sedation Research of PERC/PECARN. Additional data concerning satisfaction or discomfort were evaluated via questionnaires, and follow-up telephone calls were made to elicit information on adverse events after discharge. Results: A total of 91 patients aged 9.7 ± 3.0 years were enrolled. There was no difference between the median FPS-R score during the procedure compared to before: Median 2 and 2 (median difference 0 [95% CI 0, 0]), respectively. The FLACC score was higher during the procedure than before: Median 4 and 0 (median difference 2 [95% CI 1, 3]). UMSS was 1 (95% CI 1, 2) during the procedure. 42 (46%) patients had adverse events, all mild: vertigo (20%), nausea (16%)]or vomiting (12%). A total of 85/88 (97%) parents and 82/85 (96%) ED physicians would want the same sedation in another procedure. Conclusion: PSA with IN fentanyl and N2O seems effective in our study, as evaluated by patient assigned FPS-R. Patients were minimally sedated. Adverse events were frequent but mild. Overall, parents and medical staff would want the same agents used in another procedure. Thus, PSA with IN fentanyl and N2O appears to be an attractive option for reduction of mildly displaced fractures or dislocations.

Comparison of Oral Midazolam and Promethazine with Oral Midazolam alone for Sedating Children during Computed Tomography.

Both midazolam and promethazine are recommended to be used as sedatives in many studies but each have some side effects that limits their use. Combination therapy as an alternative method, may decreases these limitations. Therefore, this study aimed to compare midazolam with midazolam-promethazine regarding induction, maintenance, and recovery characteristics following pediatric procedural sedation and analgesia. Children under 7 years old who needed sedation for being CT scanned were included in this double-blind randomized clinical trial. The patients were randomly divided into 2 groups: one only received midazolam (0.5 mg/kg), while the other group received a combination of midazolam (0.5 mg/kg) and promethazine (1.25 mg/kg). University of Michigan Sedation Scale (UMSS) was used to assess sedation induction. In addition to demographic data, the child's vital signs were evaluated before prescribing the drugs and after inducing sedation (reaching UMSS level 2). The primary outcomes in the present study were onset of action after administration and duration of the drugs' effect. 107 patients were included in the study. Mean onset of action was 55.4±20.3 minutes for midazolam and 32.5±11.1 minutes for midazolam-promethazine combination (p<0.001). But duration of effect was not different between the 2 groups (p=0.36). 8 (7.5%) patients were unresponsive to the medication, all 8 of which were in the midazolam treated group (p=0.006). Also in 18 (16.8%) cases a rescue dose was prescribed, 14 (25.9%) were in the midazolam group and 4 (7.5%) were in the midazolam-promethazine group (p=0.02). Comparing systolic (p=0.20) and diastolic (p=0.34) blood pressure, heart rate (p=0.16), respiratory rate (p=0.17) and arterial oxygen saturation level (p=0.91) showed no significant difference between the 2 groups after intervention. Based on the findings of this study, it seems that using a combination of midazolam and promethazine not only speeds up the sedation induction, but also decreases unresponsiveness to the treatment and the need for a rescue dose.

Anesthetic approach to patient with Down syndrome and Hallervorden-Spatz disease who underwent tooth extraction.

Sir, Hallervorden-Spatz disease (HSD) is a rare neurological condition, caused by iron accumulation, which causes degeneration of the central nervous system. Blood and cerebrospinal fluid iron levels are normal. Accompanying Down syndrome (DS) is very rare.[1,2] We present our anesthetic approach with midazolam, metoclopramide, and ranitidine combination for tooth extractions of a mentally retarded, DS patient with HSD. We did not come across the use of this combination for HSD patients during the literature search. A 16-year-old male with DS, dystonia, dysarthria, gait disturbances, and sudden onset of psychotic symptoms with the diagnosis of HSD referred to Ankara University, Faculty of Dentistry, Oral and Maxillofacial Surgery Department (Turkey, 2015), for tooth extraction. General anesthesia was considered because of cooperation difficulty, agitation, and motion disorders. At preoperative examination, thyromental distance = 5 cm, sternomental distance = 10 cm, mandibulohyoid distance = 3 cm, Mallampati class was IV, atlanto-occipital joint extension was limited, and he had macroglossia. The patient was considered as a difficult intubation case. Oxygen saturation, heart beat rate, and noninvasive blood pressure were tracked. The patient with University of Michigan Sedation Scale (UMSS)-1 was oxygenized and was administered 2 mg of intravenous midazolam and metoclopramide intravenous 10 mg and ranitidine intravenous 50 mg to increase lower esophagus sphincter pressure and neutralize stomach acid. Anesthesia was maintained with 1 mg/kg of intravenous ketamine. Convenient mouth opening was achieved at UMSS 3. Extractions were carried out with no additional anesthetic agents or methods. After anesthesia termination, UMSS 1 and sufficient respiration was achieved in 4 min, general condition was good, and the patient was sent to service. In conclusion, treatment plans for HSD patients require general anesthesia when difficult intubation criteria and cooperation difficulty are present.[1,2] Sedoanalgesia under monitored anesthesia care, with titration of short-term anesthetics, and achieving UMSS 3 provides sufficient mouth opening for minor dental surgery procedures. Probable complications are prevented; mortality is decreased, fast recovery and early discharge is provided. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.

Sevoflurane Used for Color Doppler Ultrasound Examination in Children.

The objective of this study is to investigate the feasibility of sevoflurane inhalation in pediatric color doppler ultrasound examination. In this study, 30 cases of children under 1 year were selected. They were all I or II levels according to American Society of Anesthesiology. Children with severe cyanotic congenital heart disease or severe pneumonia were excluded. All the children received anesthesia with sevoflurane. The University of Michigan Sedation Scale was assessed and bispectral index (BIS) was recorded before induction (T0), after induction (T1), when maintaining (T2), and when waking-up (T3). Blood pressure and heart rate were monitored during the color doppler ultrasound examination, the time to receive sedation examination and anesthesia recovery time were also recorded. (1) Score for UMSS was zero at T0 and 3 at T1; (2) BIS value was 93.18 ± 2.94 at T0 and decreased to 87.6 ± 3.9 at T1; (3) Blood pressure or heart rate did not decline obviously; (4) The time to receive sedation examination was 46.4 ± 13.1 s and anesthesia recovery time was 7.8 ± 5.3 min. In conclusion, sevoflurane can be used in pediatric color doppler ultrasound examination safely and effectively.

The impact of clonidine on sedation after adenotonsillectomy: a prospective audit

Clonidine may be used intraoperatively to decrease emergence delirium in children, but the drug's impact on postoperative sedation is poorly quantified. A prospective audit of children (≤15 years) undergoing (adeno) tonsillectomy or adenoidectomy over a period of 4 months was carried out. All children received sevoflurane for induction and maintenance of anesthesia. The use of clonidine as an adjunct was left to the discretion of the anesthesiologist. Postoperative sedation was assessed using the University of Michigan Sedation Scale (UMSS) at 30 min intervals until discharge. Arousal was characterized using a zero asymptote model. The impact of clonidine dose on half-time to an awake state after anesthesia was investigated using nonlinear mixed effects models. Survival analysis was used to explore the effect of clonidine dose on discharge time. The mean age of children (n = 177) was 5.4 sd 3.3 years, range 0.8-15.0 years and weight was 23.8 SD 11.4 kg, range 10.0-76.4 kg. There were 73 children given clonidine 0.29-4.80 mcg·kg(-1) after induction. The half-time to emergence was 10.8 (95% CI 8.5, 13.2) min. Emergence half-time was increased to 15 min with clonidine 0.5 mcg·kg(-1), 20 min with clonidine 1.5 mcg·kg(-1), 25 min with clonidine 2 mcg·kg(-1) and 65 min with clonidine 4 mcg·kg(-1). Clonidine doses 0.5-3 mcg·kg(-1) did not affect hospital discharge time. Clonidine administered intraoperatively for (adeno) tonsillectomy or adenoidectomy prolonged emergence from anesthesia. Doses of 0.5-3 mcg·kg(-1) caused greater sedation in the postanesthesia care unit but did not impact on hospital discharge times.

An Evaluation of Intranasal Sufentanil and Dexmedetomidine for Pediatric Dental Sedation

Conscious or moderate sedation is routinely used to facilitate the dental care of the pre- or un-cooperative child. Dexmedetomidine (DEX) has little respiratory depressant effect, possibly making it a safer option when used as an adjunct to either opioids or benzodiazepines. Unlike intranasal (IN) midazolam, IN application of DEX and sufentanil (SUF) does not appear to cause much discomfort. Further, although DEX lacks respiratory depressive effects, it is an α2-agonist that can cause hypotension and bradycardia when given in high doses or during prolonged periods of administration. The aim of this feasibility study was to prospectively assess IN DEX/SUF as a potential sedation regimen for pediatric dental procedures. After IRB approval and informed consent, children (aged 3–7 years; n = 20) from our dental clinic were recruited. All patients received 2 μg/kg (max 40 μg) of IN DEX 45 min before the procedure, followed 30 min later by 1 μg/kg (max 20 μg) of IN SUF. An independent observer rated the effects of sedation using the Ohio State University Behavior Rating Scale (OSUBRS) and University of Michigan Sedation Scale (UMSS). The dentist and the parent also assessed the efficacy of sedation. Dental procedures were well tolerated and none were aborted. The mean OSUBRS procedure score was 2.1, the UMSS procedure score was 1.6, and all scores returned to baseline after the procedure. The average dentist rated quality of sedation was 7.6 across the 20 subjects. After discharge, parents reported one child with prolonged drowsiness and one child who vomited at home. The use of IN DEX supplemented with IN SUF provided both an effective and tolerable form of moderate sedation. Although onset and recovery are slower than with oral (PO) midazolam and transmucosal fentanyl, the quality of the sedation may be better with less risk of respiratory depression. Results from this preliminary study showed no major complications from IN delivery of these agents.

Manyetik rezonans görüntüleme yapılan pediatrik olgularda midazolam-ketamin kombinasyonu ile tiopental’in sedatif etkilerinin karşılaştırılması

Comparison of sedative effects of midazolam-ketamine combination and thiopental in pediatric patients undergoing magnetic resonance imaging Introduction and Aim: Children especially under age 8 cannot lie still enough for magnetic resonance imaging (MRI) or are afraid of noise and narrow spaces so sedation is necessary for high quality imaging. The aim of this study was to compare Midazolam - Ketamine combination and Thiopental sedation for children undergoing MRI. Materials and Methods: Forty randomly selected patients undergoing MRI classified as ASA physical status I and II aged between 0-8 were included in this study after receiving institutional approval from Ethics Committee. The patients were divided into two groups. Group 1 received Midazolam iv 0.1 mg kg + Ketamine iv 2 mg kg followed by an additional dose of Ketamine 0.5 mg kg. Group 2 received Thiopental iv 3 mg kg followed by an additional dose of Thiopental 1 mg kg when needed. University of Michigan Sedation Scale (UMSS) was applied. UMSS score 3 and higher were accepted for effective sedation and the patients underwent MRI. Demographic data induction process recovery and total sedation times MRI quality total anesthetic dose amount systolic and diastolic blood pressure at every 5 minutes from the beginning peak heart rate and saturation values and complications were recorded. Results: There was no significant difference in terms of age and weight between the two groups. The average induction time total sedation time and recovery time of Group 1 was significantly longer than that of Group 2 (p=0.001, p=0.035, p=0.038). There were no significant differences in PHR SBP DBP and SpO2 distributions at all times. Evaluations of the families of Midazolam - Ketamine group's patients were recorded as 19 very satisfied 1 satisfied while evaluations of the families of Thiopental group's patients were recorded as 18 very satisfied 2 satisfied. There was no significant difference between the two groups in terms of imaging quality. No side effects or complications were observed for both groups. Discussion: Thiopental was found to be a safe alternative to Midozolam - Ketamine combination in MRI. High image quality anesthesia induction time and short recovery time make Thiopental a more effective anesthetic agent for MRI.

Evaluation of the aepEX™ monitor of hypnotic depth in pediatric patients receiving propofol–remifentanil anesthesia

The aepEX Plus monitor (aepEX) utilizes a mid-latency auditory evoked potential-derived index of depth of hypnosis (DoH). This observational study evaluates the performance of the aepEX as a DoH monitor for pediatric patients receiving propofol-remifentanil anesthesia. aepEX and BIS values were recorded simultaneously during surgery in three groups of 25 children (aged 1-3, 3-6 and 6-16 years). Propofol was administered by target-controlled infusion. The University of Michigan Sedation Scale (UMSS) was used to clinically assess the DoH during emergence. Prediction probability (P(k)) and receiver operating characteristics (ROC) analyses were performed to assess the accuracy of both DoH monitors. Nonlinear regression analysis was used to describe the dose-response relationships for the aepEX, the BIS, and propofol plasma concentrations (Cp). The P(k) for the aepEX and BIS was 0.36 and 0.21, respectively (P = 0.010). ROC analysis showed an area under the curve of 0.77 and 0.88 for the aepEX and BIS, respectively (P = 0.644). At half-maximal effect (EC(50)), C(p) of 3.13 μg·ml(-1) and 3.06 μg·ml(-1) were observed for the aepEX and BIS, respectively. The r(2) for the aepEX and BIS was 0.53 and 0.82, respectively. The aepEX performs comparable to the BIS in differentiating between consciousness and unconsciousness, while performing inferior to the BIS in terms of distinguishing different levels of sedation and does not correlate well with the C(p) in children receiving propofol-remifentanil anesthesia.

Oral ketamine and midazolam for pediatric burn patients: A prospective, randomized, double-blind study

PurposeThe aim of this study was to compare the efficacy of oral midazolam and ketamine with oral midazolam, acetaminophen, and codeine in providing sedation and analgesia for wound care procedures in children with burns. MethodsThis is a prospective, randomized, double-blind study that includes patients 1 to 5years old hospitalized between 2010 and 2011, with burns covering up to 10% of total body surface area that required bedside wound care. Group 1 received oral midazolam (0.5mg/kg) and ketamine (5mg/ kg). Group 2 received oral midazolam (0.5mg/kg), acetaminophen (10mg/kg), and codeine (1mg/kg). Sedation was assessed using the University of Michigan Sedation Scale and pain using the CHEOPS scale. ResultsSixty patients were enrolled and evenly distributed into the two groups. There were a higher percentage of well-sedated patients in Group 1, but this was not statistically significant. Patients in Group 2 reported lower levels of pain (p=0.0245). Adverse reactions were reported in both groups. The only parameter that had a statistical difference was nystagmus (p=0.001). ConclusionThe combination of oral midazolam and ketamine provides better analgesia than the combination of midazolam, acetaminophen, and codeine for painful procedures in burned children.

Spectral Entropy as a Measure of Hypnosis and Hypnotic Drug Effect of Total Intravenous Anesthesia in Children during Slow Induction and Maintenance

We evaluated whether spectral entropy (SpE) can measure the depth of hypnosis and the hypnotic drug effect in children during total intravenous anesthesia. Sixty healthy children, aged 3-16 yr, were studied. Anesthesia was induced with an increasing target controlled infusion of propofol, and maintained by a stable remifentanil infusion and variable concentrations of target controlled infusion propofol. Depth of hypnosis was assessed according to the University of Michigan Sedation Scale (UMSS). Estimated plasma (C(p)) and pseudo effect site (C(eff)) propofol concentrations reflected the hypnotic drug effect. Patients were stratified to three age groups. The correlations between SpE versus UMSS, C(p), and C(eff) were analyzed by Prediction Probability (P(k)). The pharmacodynamic relationship between SpE and C(p), and the differences of SpE values between the age groups at the corresponding UMSS levels, were studied. Respective mean P(k) values for the youngest, middle, and oldest age groups were: 1) during induction: SpE versus UMSS 0.87, 0.87, and 0.93; SpE versus C(p) 0.92, 0.95, and 0.97; and SpE versus C(eff) 0.88, 0.94, and 0.95; 2) during maintenance: SpE versus C(eff) 0.86, 0.75, and 0.81. The pharmacodynamic analysis determined an association between SpE and C(p) that followed the E(max) model closely. There were significant differences in SpE values between age groups at corresponding UMSS sedation levels. SpE measures the level of hypnosis and hypnotic drug effect in children during total intravenous anesthesia. There is an age dependency associated with SpE. Anesthesia should not be steered solely on the basis of SpE.

Intranasal Fentanyl and High‐concentration Inhaled Nitrous Oxide for Procedural Sedation: A Prospective Observational Pilot Study of Adverse Events and Depth of Sedation

Nitrous oxide (N(2)O) is an attractive agent for pediatric procedural sedation and analgesia (PSA) with rapid onset and offset of sedation. However, it has limited analgesic efficacy. Intranasal fentanyl (INF) provides nonparenteral analgesia. There are currently no data on the combined use of N(2)O and INF for PSA in children. The authors set out to prospectively assess the depth of sedation and incidence of adverse events when N(2)O and INF are used in combination in pediatric patients. This was a prospective observational pilot study of combined N(2)O and INF for PSA at a tertiary children's hospital emergency department (ED). INF was administered at a precalculated dose of 1.5 μg/kg for preascertained weight ranges. N(2)O concentration, dose, timing of INF, adverse events, and sedation depth were recorded. Sedation depth was recorded using the University of Michigan Sedation Scale (UMSS). A total of 41 patients, aged 1 to 14 years, received INF within 2 hours prior to N(2)O. N(2)O was administered at a maximal concentration of 70% in 40 patients, and at 50% in one patient. Most patients (80%) were minimally to moderately sedated (sedation score 1 or 2). Deep sedation (sedation score 3) was recorded in 14.6% of patients (95% confidence interval [CI] = 3.4% to 24.6%). No patients had serious adverse events; vomiting was recorded in 19.5% (95% CI = 7.4% to 31.6%). There were two patients (4.9%) who were deeply sedated and vomited during the procedure. There were no serious adverse events identified in this pilot study of combined N(2)O and INF. However, there was an increased incidence of vomiting and deeper levels of sedation when compared to published data of single-agent use of N(2)O, which could lead to more serious adverse events. Further investigation is needed to establish the analgesic efficacy of combining N(2)O and INF and to clarify the safety profile before this combination can be recommended for PSA in children.

Bispectral Index Monitoring of Sedation Depth in Pediatric Dental Patients

The bispectral index (BIS) monitor records electroencephalogram waveforms and provides an objective measure of the hypnotic effect of a sedative drug on brain activity. The aim of this pilot study was to use the BIS monitor to evaluate the depth of procedural sedation in pediatric dental patients and to assess if the BIS monitor readings correlate with a validated pediatric sedation scale, the University of Michigan Sedation Scale (UMSS), in determining the level of sedation in these patients. Thirty-five pediatric dental patients requiring sedation were studied prospectively. A baseline BIS reading was obtained and during the procedure an independent observer recorded the BIS every 5 minutes. The operator, who was blinded to the BIS results, determined the UMSS scale at the same 5-minute interval. The patients were monitored postoperatively for 1 hour. There was a significant but moderate correlation between BIS values and UMSS scores (Spearman's rank correlation r = -0.574, P < .0001). Percentage of agreement and kappa coefficient using all the observations were also calculated. The percentage of agreement was 37.8%, the kappa coefficient was 0.18 (P < .0001), and the weighted kappa coefficient 0.26 (P < .0001). A lack of correlation was noted between the deeper levels of UMSS sedation scores and BIS values. This study demonstrated a significant correlation between BIS values and the UMSS score in pediatric dental patients undergoing mild to moderate sedation. Based on our results, it appears that the BIS monitor may be useful during mild or moderate sedations to establish the level of sedation objectively without the need to stimulate the patient.

Optimal sedative dose of propofol to start MRI in children with cerebral palsy

BackgroundThis study was designed to determine the optimal sedative dose of propofol to start brain magnetic resonance imaging (MRI) in children with cerebral palsy (CP).MethodsTwenty children, aged 0.5-5 years, were administered propofol to achieve a University of Michigan Sedation Scale (UMSS) score ≥ 3 in the MRI room. The proper dose of propofol was determined using the up-and-down method.ResultsThe ED50 and ED95 for successful sedation with a UMSS ≥ 3 were 2.07 mg/kg (95% CI 1.69-2.56) and 2.69 mg/kg (95% CI 2.35-5.59). Respiratory events occurred in 5 patients and were resolved with neck extension, chin lift, or transient respiratory assistance with successful sedation.ConclusionsLow dose propofol can safely facilitate the initiation of MRI in children with CP.

Premedication with oral midazolam with or without parental presence

In this study, we aimed to investigate whether the combination of low-dose (0.25 mg kg(-1)) midazolam premedication with parental presence can effectively reduce anxiety at induction as well as provide a smoother emergence. Institutional ethics committee approval and informed consent from one of the parents were obtained prior to the study. Sixty ASA grade I or II children undergoing surgery were enrolled in the study. Children were randomized to receive either 0.5 mg kg(-1) midazolam orally (group M) or 0.25 mg kg(-1) midazolam orally with parental presence (group MP) or parental presence alone (group P). The child's anxiety and sedation scores were evaluated as 1-4 points on the Anxiety Scale and as 0-4 points on the University of Michigan Sedation Scale (UMSS), respectively, at the entrance to the operating room and for tolerance to the face mask. Heart rate, the mean arterial blood pressure and O2 saturation (%) were assessed at repeated intervals before and after induction. At the end of surgery, the child's Anxiety Scale score, UMSS score, Observer's Pain Scale (OPS) score and FLACC score were also assessed. There were no differences between groups in demographic variables and duration of surgery or anaesthesia. Mean blood pressure changes were similar between groups at measured intervals, but the heart rate was higher in group M before and after induction of anaesthesia (P<0.05). UMSS score was greater in both midazolam groups (groups M and MP) in the preoperative period (P<0.05). Anxiety Scale scores for anxiolysis were higher in groups M and MP than in group P (less anxious and more sedated) at 20 min after premedication, at the entrance to the operating room and at mask tolerance time points (P<0.05). During recovery there was no significant difference in sedation, recovery scores or behavioural anxiety assessment between groups, Anxiety Scale score, UMSS score, FLACC score, Visual Analog Scale (VAS) score and Observer's Pain Scale score in groups MP, M and P. Preoperative administration of midazolam 0.5 mg kg(-1) for premedication alone, without parental presence at induction, and that of low-dose midazolam 0.25 mg kg(-1) for premedication with parental presence at induction are both equally effective in reducing separation anxiety and providing a smooth emergence. However, parental presence alone, without midazolam for premedication, is not an adequate approach for this outcome. If the environment for parental presence is convenient, the dose of midazolam may be reduced and induction and emergence conditions may still be of high quality.