Medications In Pediatric Patients Research Articles

Psychiatric and behavioral concerns of perampanel with concomitant levetiracetam in children with epilepsy

PurposePerampanel (PER) is expanding the therapeutic scope for pediatric epilepsy owing to its efficacy and favorable safety profile. However, concerns about psychiatric and behavioral adverse events (PBAEs) in combination therapy with levetiracetam (LEV) continue to contribute to hesitation in its prescription. We investigated the risk profiles for PBAEs when adding PER to pediatric epilepsy treatment and analyzed the differences according to the presence of concomitant LEV. MethodsWe retrospectively reviewed the medical records of children aged 4–18 years with epilepsy who were prescribed PER as adjunctive therapy from March 2016 to February 2023. We compared the occurrence and management of PBAEs between the PER without LEV and PER with LEV groups. The risk factors for PBAEs were also analyzed. ResultsNinety-four patients (53 boys and 41 girls) were included in this study. The median age of total patients at the time of adding PER was 14.9 years (12.3–16.4 years), and 53 patients (56.4 %) had concomitant LEV. Forty-seven PBAEs occurred in 34 patients (36.2 %), with no significant differences depending on whether concomitant LEV is present or not. The most common PBAEs were aggression (14.9 %), irritability (9.6 %), affect lability (7.4 %), and acute psychosis (6.4 %). PBAEs occurred at a lower dosage (2–6 mg/day) in 70.6 % of the patients. In addition, 73.5 % of patients with PBAEs continued PER treatment by follow-up observation or by reducing the PER dosage. No risk factors, such as the presence of concomitant LEV or lamotrigine, any comorbid conditions, higher PER dosage (8–12 mg/day), two or more concomitant anti-seizure medications, and younger age (<13 years) at PER add-on, showed significant associations. ConclusionWhen expanding the use of anti-seizure medications in pediatric patients, real-world evidence on safety issues is crucial for pediatric epileptologists. We confirmed that combination therapy with PER and LEV did not increase the risk profile of PBAEs.

Micropulse transscleral cyclophotocoagulation (MP-CPC): efficacy endpoints for the treatment of refractory paediatric glaucoma - a retrospective case-series

BackgroundThis study evaluates the efficacy and safety of micropulse transscleral cyclophotocoagulation (MP-CPC) in paediatric patients.MethodsThis retrospective case-series recruited 44 eyes for glaucoma patients who were younger than 17 years and were treated with MP-CPC and followed for at least one year. Pre- and post-intervention intraocular pressure (IOP) was compared out to at least one year postoperatively. Success rates at 6 months and 1 year postoperatively were assessed. P < 0.05 was considered statistically significant.ResultsThere were 35 (79.5%) eyes with a history of glaucoma surgery. IOP decreased statistically significantly from a baseline of 32.7 (standard deviation:8.7 mmHg) to 23.2 (8.6) and 21.7 (7.9) mmHg at the 6 months and 1-year follow-up, respectively (P < 0.0001, all comparisons). Overall success was noted in 19 (47.5%) eyes at the 6 months follow-up, and 23 (53.5%) eyes at 1 year.ConclusionsMP-CPC reduces IOP and the burden of medications in paediatric patients with glaucoma. Additionally, its safety profile favours the use of MP-CPC as an adjunctive modality for refractory glaucoma.

Analysis of Factors Associated with Adherence to Taking Medication in Pediatric Patients with Pulmonary Tuberculosis in Mesuji Regency, Lampung, Indonesia

Analysis of Factors Associated with Adherence to Taking Medication in Pediatric Patients with Pulmonary Tuberculosis in Mesuji Regency, Lampung, Indonesia

How Compounding Pharmacies Fill Critical Gaps in Pediatric Drug Development Processes: Suggested Regulatory Changes to Meet Future Challenges.

Drugs administered to children in the United States fall into two broad categories: (1) those that have followed the US Food and Drug Administration (US-FDA) pediatric drug approval process and are marketed as finished dosage forms with pediatric labeling; and (2) all others, many of which are used "off-label". The use of most drug products in pediatrics is still off label, often requiring special preparation, packaging, and, in some cases, compounding into preparations. The latter category includes compounded preparations that incorporate either a US-FDA approved finished dosage form (e.g., a sterile solution, sterile powder, nonsterile capsules, oral solution, crushed tablets, etc.), or rely on bulk active pharmaceutical ingredients (APIs). Compounded preparations are prepared for individual patients in 503A pharmacies, or on a larger scale and not just for specific patients, in licensed 503B establishments. Critical gaps in the current drug approval process for finished dosage forms have created a proverbial "Gordian knot" that needs to be untangled thoughtfully to facilitate increased production and approval of vitally needed medications for pediatric patients. This opinion will describe current regulatory processes pertaining to pediatrics-only drug approval in the United States. Additionally, discussed are steps required for a product to acquire pediatric labeling. Gaps in regulatory approval pathways for both manufactured and compounded pediatric drugs will be identified, especially those that complicate and slow development and availability to patients. Finally, suggestions for regulatory modifications that may enhance pediatric product development strategies for both manufacturers and compounders are suggested.

Comparing the Effectiveness of Honey Consumption With Anti-Cough Medication in Pediatric Patients: A Systematic Review.

Coughing is one of the most prevalent symptoms in children presenting at outpatient departments. This systematic review aimed to review previous literature in order to compare the use of honey and antitussive medications for treating coughs in children. Literature was screened across five databases using Medical Subject Heading (MeSH) strategy, keywords, and inclusion and exclusion criteria. The remaining literature was evaluated using a quality appraisal tool checklist. This review includes systematic reviews, ‎‎meta-analyses, randomized controlled trials (RCTs), observational studies, cross-sectional studies, and articles ‎without ‎a defined ‎methodology section. This review suggests that honey is effective in treating children above 12 months of age, while cold and cough medications (CCMs) are safe if administered at therapeutic doses. Since fatalities can occur in children under two years of age, further RCT studies on CCMs are required to establish safety across all age groups.

WS10.06 Adherence to nebulised medication in paediatric patients with cystic fibrosis following introduction of modulator therapy

WS10.06 Adherence to nebulised medication in paediatric patients with cystic fibrosis following introduction of modulator therapy

Adjunctive use of cenobamate for pediatric refractory focal-onset epilepsy: A single-center retrospective study

ObjectiveWe explored the efficacy and safety profile of cenobamate as an adjunctive therapy in patients with refractory focal-onset epilepsy in the pediatric population. MethodsThis was a retrospective, single-center study of cenobamate used as an adjunctive medication in pediatric patients with refractory focal-onset epilepsy . We measured seizure reduction, median reduction in seizure frequency, median dose, responder rate, and treatment-emergent adverse events. ResultsWe studied the efficacy and safety profile of cenobamate in 21 pediatric patients (mean age 15.9). Cenobamate was up titrated using the prescribed starter pack with final doses ranging from 100 mg to 400 mg daily. The mean and median dose of cenobamate was 209.8 mg (±98.87 mg) and 200 mg (175–275), respectively. For patients weighing less than 50 kg, mean and median dose was 4.0 mg/kg/day (3.20–4.63) and 4.32 mg/kg/day, respectively. Mean and median baseline seizure frequency per month in this cohort was 15.38 and 16, respectively, prior to the introduction of cenobamate. After the adjunctive use of cenobamate, mean and median seizure frequency per month reduced to 7.29 and 1, respectively; median reduction in seizure frequency was 93.7%. Seizure reduction of at least 50% (responder rate) was noted in 13 (62.5%) patients and a seizure reduction of at least 75% noted in 11 (52.4%) patients, similar to that seen in adults. Four patients (19%) achieved seizure freedom. Of the 21 pediatric patients, 9 (42.8%) patients had treatment-emergent adverse events (TEAE) with the most commonly reported symptom being ataxia (5, 23.8%) and sedation (2, 9.5%). Three (14.3%) patients discontinued early due to these side effects. No children developed drug rash with eosinophilia and systemic symptoms (DRESS). ConclusionCenobamate demonstrates similar efficacy rates and safety profile within the pediatric population when compared to the published adult data, making it an effective, safe, and tolerable adjunctive medication for children with refractory focal-onset epilepsy, even at the maximum daily dose.

Impact of Cangrelor Use in Children Supported on Paracorporeal Ventricular Assist Devices

<h3>Purpose</h3> Paracorporeal ventricular support devices (pVAD) are increasingly utilized in pediatric patients with end-stage heart failure as either bridge to recovery or as bridge to heart transplant. Unfortunately, thromboembolic events are not uncommon with use of pVAD with neurologic dysfunction occurring in 15-18% of patients. The optimal antithrombotic regimen is a subject of ongoing study. Cangrelor is an intravenous P2Y12 inhibitor used in adult patients undergoing percutaneous coronary intervention; its pharmacokinetic properties, including intravenous administration, short half-life, and avoidance of cytochrome p450 pathway, make it appealing as a safe and effective platelet inhibitor. We describe our pediatric experience with cangrelor anti-platelet therapy utilized throughout the duration of pVAD support. <h3>Methods</h3> Single-institution, retrospective chart review was conducted on all patients in a tertiary medical center with end-stage heart failure (INTERMACS level 1 or 2) supported with pVAD and receiving cangrelor infusion between June 2019 and October 2021. <h3>Results</h3> Seven patients were supported on continuous pVAD, and two were subsequently transitioned to pulsatile paracorporeal VAD. Median age was 8 months, and median weight was 6.7 kg. Four patients had a diagnosis of complex congenital heart disease. Three patients had dilated or restrictive cardiomyopathy, one of whom was admitted with fulminant myocarditis. Median number of days of continuous VAD support was 24.5 days (IQR 9-64 days). Cangrelor was initiated within 24 hours post-implant at a dose of 0.1 mcg/kg/min. Median time to therapeutic P2Y12 was 18 hours (IQR 13-32), and median duration of cangrelor therapy was 24 days. Mean dose to maintain therapeutic level was calculated, with a median of 0.25 mcg/kg/min (IQR 0.12-0.41 mcg/kg/min). Mean P2Y12 level was 169 PRU. Neurologic complications were encountered in one patient who died following hemorrhagic stroke. One patient experienced a GI bleed. <h3>Conclusion</h3> Cangrelor is safe and effective for use as a long-term antithrombotic medication in pediatric patients supported on pVAD. The frequency of adverse events was similar to that in previously published registry studies. The reliability of its intravenous administration and its short half-life make it appealing as an alternative to oral anti-platelet agents.

Comparison of domain specific connectivity metrics for estimation brain network indices in boys with ADHD-C

The goal of the present study is to propose the use of global connectivity measures as quantitative indicators of long-term medication in pediatric patients with Attention-Deficit-Hyperactivity Disorder, combined type (ADHD-C). For this purpose, graph theoretical brain connectivity indices are computed from connectivity estimations across eyes-opened resting-state EEG recordings measured before and after the treatment with osmotic release oral system-methylphenidate for a month in 18 boys (aged between 7–12 years). In order to present the reliable results, neurofunctional correlations are firstly estimated in time (Pearson Correlation (PC), Spearman Correlation), frequency (Directed Transfer Function, Partial Directed Coherence) and phase (Phase Locking Value, Phase Lag Index) domains in between short segments of 2sec over single trials of 1min. Later, transitivity, clustering coefficients, assortativity, global efficiency and modularity are computed from EEG based connectivity matrices produced by each approach. Since the highest classification accuracy of 83.79% is provided by PC, statistical tests (one-way Anova, pair-wise multiple comparison) and step-wise logistic regression modelling are all examined to detect significant differences between pre- and post- treatment relevant connectivity measures. Statistical boxplots are also shown, as well. Overall results reveal that global brain connectivity can be increased by long-term medication in pediatric ADHD-C in terms of increased segregation & resilience. This is the first study to demonstrate that long-term medication can normalize the functional brain connectivity in ADHD, which is characterized by decreased connectivity compared to controls.

A comparative study of intranasal dexmedetomidine and intranasal midazolam for premedication - A prospective randomized double-blind study in children posted for tonsillectomy

Preanesthetic medication in paediatric patients is well known to be a challenge for anaesthesiologists. Premedication in paediatric population helps to produce a relaxed state with reduced anxiety and increased compliance as well as to ease separation from parent and allowing the patient to tolerate and co-operate with the necessary procedure. Our aim is to do a comparation of dexmedetomidine and midazolam given via intranasal route in children posted for tonsillectomy as premedication.This study was conducted in 100 patients of 6 to 12 years posted for tonsillectomy. Patients were randomly allocated into Group M and D. Patient in group M (50) received 0.2mg/kg of midazolam administered intranasally as nasal drop using 1ml insulin syringe and similarly group D (50) received 1µg/kg of dexmedetomidine administered intranasally as nasal drops using 1ml insulin syringe. Sedation score, Anxiolysis score, mask induction score, post-operative agitation score was assessed.Satisfactory sedation was achieved by 86% and 68% of patient in dexmedetomidine and midazolam respectively p (0.03). Satisfactory mask induction was achieved by 84% and 70% of patient in dexmedetomidine and midazolam respectively p (0.09). In terms of post op agitation score there is no difference in both the group p (0.30). During the time between administration of pre op drugs and initiation of anaesthesia, no patient seems to develop hypotension, hypoxia or any other life-threatening complicationIn our study we concluded that in terms of decreasing anxiety at parental separation both dexmedetomidine and midazolam were found to be equally effective. However, Intranasal dexmedetomidine produced superior sedation scores at separation and induction compared to oral midazolam in paediatric patients.

Controlling carbohydrate content in antiepileptic medications for children on a ketogenic diet

Introduction: patients who follow a ketogenic diet for the control of epileptic seizures must carry out a strict control of carbohydrates from the foods they eat and the medicines they are prescribed. In the initiation of a ketogenic diet and when a doctor prescribes a new medication, it is necessary to select the most appropriate pharmaceutical form so that the supply of excipients in the form of carbohydrates from the drugs is minimized. Objectives: the goal of the present paper was to compile a list of carbohydrate and caloric contents in antiepileptic drugs commonly used in pediatric neurology. Methods: in each medication included in the list, the content of excipients considered carbohydrates and derivatives that could influence the patient's ketosis was reviewed. The caloric content from carbohydrates and polyols in each medication was calculated. Results: the table provides the total carbohydrate and caloric content for antiepileptic medications in pediatric patients consuming the ketogenic diet. Conclusions: this table is intended to be a useful tool to help clinicians select a pharmaceutical form that is less likely to affect the ketogenic diet. Additionally, knowing the carbohydrate content of a new medication will allow adjustment of the diet to maintain ketosis.

Ontogeny of Pediatric Pharmacogenetics: Celebrating the Past and Vision for the Future.

Ontogeny of Pediatric Pharmacogenetics: Celebrating the Past and Vision for the Future.

Efficacy and safety of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers for IgA nephropathy in children.

IgA nephropathy (IgAN) is one of the most prevalent primary glomerulopathies in children. There are various studies investigating the efficacy of angiotensin-converting enzyme inhibitors (ACEI) and angiotensin II receptor blockers (ARB) in adults with IgAN. However, only few studies evaluated the efficacy of these medications in pediatric patients. To evaluate the efficacy and safety of ACEI/ARB in children with IgAN. Databases including PubMed, Web of Science, Cochrane, Scopus, and Google Scholar were searched between the 1st of April and 20th of July of 2021 using the keywords "IgA Nephropathy," "Berger's Disease," "Angiotensin-Converting Enzyme Inhibitors," "Angiotensin Receptor Antagonists," "Angiotensin II Type 1 Receptor Blockers," and similar entry terms collected from the Medical Subject Headings (MeSH). Observational studies (case series, case-control, cohort, and cross-sectional) and clinical trials with descriptions of pediatric patients (under 19years old) with histopathological diagnosis of IgA nephropathy and who received ACEI and/or ARB. Pediatric patients (under 19years old) with histopathological diagnosis of IgA nephropathy and who received ACEI and/or ARB. For quality assessment, the Risk of Bias 2 tool (RoB 2), the Risk Of Bias In Non-randomized Studies of Interventions tool (ROBINS-I), the National Institutes of Health (NIH) quality assessment tool, and the Newcastle-Ottawa Scale (NOS) were used. After recovering 1,471 studies, only eight, published between 2003 and 2019, met the eligibility criteria and were included in this systematic review. Of the 737 included children in the studies, 202 (25.8%) used ACEI/ARB and were compared with placebo and other therapy regimens. Of the seven studies that evaluated proteinuria, six reported an efficacy of ACEI/ARB in reducing this marker. ACEI/ARB also showed a possible effect in reducing hematuria and oxidative stress. The most common side effect was dizziness. The number of studies about the treatment with ACEI/ARB in children with IgAN is scarce. In addition, the studies are very heterogeneous. There are few studies that compared ACEI/ARB with placebo. The use of ACEI and/or ARB appears to be safe and to reduce proteinuria in pediatric patients with IgAN. Nonetheless, further randomized controlled trials, with greater methodological rigor and longer follow-up time, are required to establish the efficacy and safety of this therapy in this population. The protocol of this systematic literature review was registered in PROSPERO under the number CRD42021245375, and in the OSF registries ( https://osf.io/qft4z/ ) with the registration https://doi.org/10.17605/OSF.IO/VADYR . A higher resolution version of the Graphical abstract is available as Supplementary information.

Language Barriers and Timely Analgesia for Long Bone Fractures in a Pediatric Emergency Department.

IntroductionLong bone fractures are common painful conditions often managed in the pediatric emergency department (PED). Delay to providing effective pediatric pain management is multifactorial. There is limited information regarding how the issue of language spoken impacts the provision of adequate and timely institution of analgesia. We sought to determine whether there is a difference between English-speaking and non-English speaking patients with respect to time to pain management for long bone fractures in a multi-ethnic urban PED.MethodsWe conducted a retrospective cohort study of consecutive cases over 29 months of children <18 years old who presented to the PED with a first-time long bone fracture. A correlation of multiple clinical variables with timeliness to providing analgesia as a primary outcome was determined. We performed regression analysis to eliminate confounding and to determine the magnitude of each variable’s effect on the outcome.ResultsWe analyzed a total of 753 patient cases (power 0.95). Regression analysis showed that the variable of English vs non-English language spoken was the most significant predictor of timeliness to pain management (p < 0.001). There was a significant difference in median time to triage measurement of pain score (1 minute vs 4 minutes for English vs non-English speakers [p < 0.001]); median time to initial analgesia (4 minutes vs 13 minutes for English vs non-English speakers (p < 0.001]); and median time to opioid analgesia (32 minutes vs 115 minutes for English vs non-English speakers (p < 0.001]), respectively. All measurements of time were from the creation of a patient’s electronic health record. Just 30% of all patients received an opioid analgesic for treatment of long bone fractures, including only 37% with moderate triage pain scores.ConclusionDelay to receiving analgesic medications in pediatric patients with long bone fractures can be augmented by language barriers. Time to providing analgesia for long bone fractures is significantly delayed in non-English speaking families, contributing to disproportionate care in the PED. Furthermore, use of opioid analgesia for fractures in children remains poor.

Training on intravenous medication administration in pediatric nursing: a before-after study.

To evaluate the effect of training on intravenous medication administration in pediatric patients on nursing staff 's learning and response. This is a quasi-experimental study (pre- and post-test), with 38 nursing professionals who participated in training on administration of intravenous (IV) medication in pediatric patients with heart disease. For data collection, a questionnaire with 19 items was applied to evaluate participants' learning before (pre-test) and after (post-test) training. Data were analyzed by descriptive and analytical statistics (binomial and Friedman tests). Nurses predominated (52.6%), mean age 41.2 years and 9.8 years of professional experience in pediatrics. For learning evaluation, there was an increase in the rate of hits from the pre-test to the post-test in 13 items, with a significant difference (p < 0.05) in the items: removing adornments to sanitize hands; wearing gloves when administering medication; administering medication with gloves, mask and goggles; and checking patient name by asking their companion. Training had positive effects on nursing professionals' learning and reaction.

Fludrocortisone in Pediatric Vasovagal Syncope: A Retrospective, Single-Center Observational Study.

Background and PurposeThe purpose of this study was to determine the effect of fludrocortisone in patients with pediatric vasovagal syncope (VVS).MethodsThis retrospective observational single-tertiary-center study based on chart reviews included 74 patients who were newly diagnosed with VVS in the head-up tilt-table test (HUTT). Some of the patients had been treated with fludrocortisone. All patients were assessed using a brain and cardiac workup before treatment to rule out the syncope being due to other causes, which resulted in seven of them being excluded: two for epilepsy and five for brain pathologies. The remaining 67 patients were analyzed. The effect of fludrocortisone was evaluated based on the results of a follow-up HUTT, with a response to the treatment considered to be present if there was a negative change at the follow-up HUTT. Univariate logistic regression were used for statistical analyses, with the criterion for significance being p<0.05.ResultsThere were no significant differences in the characteristic of the patients between the no-medication (n=39) and fludrocortisone (n=28) groups, including age, sex, and duration of treatment. The recurrence rate of syncopal or presyncopal events was significantly lower in the fludrocortisone group (39.3%, 11 of 28) than in the no-medication group (64.1%, 25 of 39) (p=0.044), as was the rate of negative change at the follow-up HUTT: 57.1% (16 of 28) and 28.2% (11 of 39), respectively (p=0.017).ConclusionsOur findings suggest that fludrocortisone is more effective than no medication in pediatric patients with VVS.

Comparative study between oral midazolam and oral ketamine as preanaesthetic medication in paediatric patients undergoing elective surgery: a randomized double blind study

Introduction: Prime objective of anaesthesiologist is to minimize adverse psychological and physiological effects of anaesthetic technique. Premedication causes sedation and reduction of anxiety during separation from parents. It also provides a calm and cooperative child for smooth induction of anesthesia. We evaluated the differences in quality of premedication with orally administered midazolam and ketamine in the paediatric population undergoing elective surgical procedures and tried to ascertain the minimum interval required between premedication and parental separation. Objective: This study was undertaken to compare the efficacy and safety of oral midazolam and oral ketamine as a preanaesthetic medication for paediatric patients undergoing elective surgery. Materials and Methods: In this prospective, randomized, double blind study a total of 60 children aged 1-6 years, belonging to ASA grade 1 and 2, scheduled for elective surgery were randomized into two groups of 30 each to receive either midazolam 0.5 mg/kg (Group A) or ketamine 5 mg/kg (Group B) orally. Parameters to be assessed were quality of sedation and anxiolysis, ease of parent-child separation and ease of venepuncture. Results: Overall success rate of midazolam for sedation and anxiolysis was higher than ketamine in all the time frames. Successful separation from parents was easy in 25 patients (83.33%) in group A and 13 patients (43.33%) in group B. Successful venepuncture was obtained in 93.33% and 90% of patients in group A and group B respectively. This higher rate of success during venepuncture was probably due to use of EMLA cream prior to venepuncture. Conclusion: We concluded that premedication with oral midazolam 0.5mg/kg provides better sedation and anxiolysis, easy parent child separation than oral ketamine 5mg/kg. Keywords: Midazolam, Ketamine, Preanaesthetic, Anxiolysis, Venepuncture.

Preferential Antiseizure Medications in Pediatric Patients with Convulsive Status Epilepticus: A Systematic Review and Network Meta-Analysis

The optimal choice for first- and second-line antiseizure medications for pediatric patients with convulsive status epilepticus remains ambiguous. The present study aimed to estimate the comparative effect on the efficacy and safety of different antiseizure medications in pediatric patients with status epilepticus and provide evidence for clinical practice. We searched PubMed, EMBASE, and the Cochrane Library for eligible randomized controlled trials. Inclusion criteria included: (1) pediatric patients; (2) diagnosis of status epilepticus; and (3) randomized controlled trials. Exclusion criteria were: (1) mixed population without a pediatric subgroup analysis; (2) not status epilepticus; (3) received the study drug prior to admission; (4) sample size fewer than 30; and (5) not randomized controlled trials. Primary outcome was seizure cessation. Secondary outcomes were seizure recurrence within 24h, respiratory depression, and admission to an intensive care unit. The hierarchy of competing antiseizure medications was presented using the surface under the cumulative ranking curve. Eight first-line antiseizure medication studies involving 1686 participants and eight second-line antiseizure medication studies involving 1711 participants were eligible for analysis. Midazolam, diazepam, lorazepam, and paraldehyde were administered as first-line antiseizure medications. Valproate, phenobarbital, phenytoin, fosphenytoin, and levetiracetam were investigated as second-line antiseizure medications. No significant differences were observed across first- and second-line antiseizure medications. Midazolam ranked the best for primary and secondary outcomes among the first-line antiseizure medications. Phenobarbital ranked the best for seizure cessation and a lower risk of admission to the intensive care unit. Valproate had superiority in preventing recurrence within 24h. Levetiracetam had the lowest probability of developing respiratory depression. This study demonstrated the hierarchy of competing interventions. Midazolam could be a better option for first-line treatment. Phenobarbital, levetiracetam, and valproate had their respective superiority in the second-line intervention. This study may provide useful information for clinical decision making under different circumstances.

0923 Doxepin in Children and Adolescents With Symptoms of Insomnia: A Single Center Experience

Abstract Introduction Pediatric insomnia is a widespread problem and especially difficult to manage in children with neurodevelopmental disorders. There are currently no FDA- approved medications for pediatric patients to use once first line therapy fails. Doxepin is FDA-approved at low doses for use in transient or chronic sleep maintenance insomnia in adults. The objective of this study is to determine the tolerability and efficacy of doxepin in the pediatric population. Methods This is a retrospective single center chart review of children and adolescents (2-17 years of age) whose sleep failed to improve with behavioral intervention and melatonin who were then trialed on doxepin. Treatment was initiated at a median starting dose of 2mg and slowly escalated to a median maintenance dose of 10mg. Improvement in sleep was recorded using a 4-point Likert scale reported by parents on follow up visits. Results Total of 29 patients were included in analysis. Mean follow-up duration was 6.5 months (±3.5). Out of 29 patients, 4 (13.8%) patients discontinued doxepin due to lack of efficacy or side effects. 8 (27.6%) patients showed significant improvement of their insomnia, 8 (27.6%) showed moderate, 10 (34.5%) showed mild and 3 (10.3%) showed minimal to no improvement on treatment with doxepin (P&amp;lt;0.05) Only two patients (6.8%) experienced adverse effects in the form of behavioral side effects (aggression) and enuresis. Conclusion Our data suggests that doxepin is effective, safe and well-tolerated in the treatment of sleep initiation and maintenance insomnia as well as psychophysiological insomnia in child and adolescents with Ausitsm specutrm disorder, other neuro-developmental disorders and attention deficit hyperactivity disorder. It is also an effective, safe, and well-tolerated alternative in children suffering from chronic persistent insomnia. The results of this study suggests a promising emerging therapy for the treatment of insomnia in the pediatric population. Support None

Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List.

The safe use of medications in pediatric patients requires practitioners to consider the unique pharmacokinetics and pharmacodynamics of drugs prescribed in this age group. In an effort to create a standard of care for the safe use of medications in this population, a list of drugs that are potentially inappropriate for use in pediatric patients has been developed and titled the "KIDs List." A panel of 7 pediatric pharmacists from the Pediatric Pharmacy Association were recruited to evaluate primary, secondary, and tertiary literature; FDA Pediatric Safety Communications; the Lexicomp electronic database; and product information for drugs that should be considered potentially inappropriate for use in pediatric patients. Information was rated using predefined criteria. A PubMed search was conducted using the following terms: adverse drug events OR adverse drug reactions. The search was limited to humans; age <18 years; case reports, observational studies, or clinical trials; and English language. No date range was used. Results were used to create an evidence-based list of candidate drugs that was then peer-reviewed and subjected to a 30-day public comment period prior to being finalized. A PubMed search yielded 4049 unique titles, of which 210 were deemed relevant for full review. Practitioner recommendations highlighted an additional 77 drugs. FDA Pediatric Safety Communications and the Lexicomp database yielded 22 and 619 drugs, respectively. After critical analysis, peer review, and public review the final KIDs List contains 67 drugs and/or drug classes and 10 excipients. This extensive effort led to compilation of the first list of drugs that are potentially inappropriate for prescribing in all or in a select subgroup of pediatric patients. If avoidance is not clinically possible, the drug should be used with caution and accompanied by appropriate monitoring.