Chloral Hydrate,Chloral Hydrate - Promethazine and Chloral Hydrate -Hydroxyzine Efficacy in Electroencephalography Sedation

Objective

To compare efficacy and safety of chloral hydrate (CH), chloral hydrate and promethazine (CH + P) and chloral hydrate and hydroxyzine (CH + H) in electroencephalography (EEG) sedation.

Methods

In a parallel single-blinded randomized clinical trial, ninety 1–7 y-old uncooperative kids who were referred to Pediatric Neurology Clinic of Shahid Sadoughi University, Yazd, Iran from April through August 2012, were randomly assigned to receive 40 mg/kg of chloral hydrate or 40 mg/kg of chloral hydrate and 1 mg/kg of promethazine or 40 mg/kg of chloral hydrate and 2 mg/kg of hydroxyzine. The primary endpoint was efficacy in sufficient sedation (obtaining four Ramsay sedation score) and successful completion of EEG. Secondary endpoint was clinical adverse events.

Results

Thirty nine girls (43.3 %) and 51 boys (56.7 %) with mean age of 3.34?±?1.47 y were assessed. Sufficient sedation and completion of EEG were achieved in 70 % (N?=?21) of chloral hydrate group, in 83.3 % (N?=?25) of CH + H group and in 96.7 % (N?=?29) of CH + P group (p?=?0.02). Mild clinical adverse events including vomiting [16.7 % (N?=?5) in CH, 6.7 % (N?=?2) in CH + P, 6.7 % (N?=?2) in CH + H], agitation in 3.3 % of CH + P (N?=?1) group and mild transient hypotension in 3.3 % of CH + H (N?=?1) group occurred. Safety of these three sedation regimens was not statistically significant different (p?=?0.14).

Conclusions

Combination of chloral hydrate—antihistamines can be used as the most effective and safe sedation regimen in drug induced sleep electroencephalography of kids.     

Comparison of Oral and Buccal Midazolam for Pediatric Dental Sedation: A Randomized,Cross-Over,Clinical Trial for Efficacy,Acceptance and Safety

Objective

Providing a safe and efficient dental treatment for a young patient is a challenge for the dentist and the child. The purpose of this study was to investigate the effectiveness, safety and acceptability of buccal midazolam in dental pediatric patients and to compare it with oral Midazolam.

Methods

Eighteen uncooperative healthy children aged 2.5-6 years were randomized to each of buccal midazolam (0.3mg/kg) or oral midazolam (0.5mg/kg) at the first visit, the alternative has been used at the second visit in a cross-over manner. The study took place at pediatric dentistry clinic of Shahed University, Tehran, from November 2011 to June 2012. The patients‘ vital signs and behavioral scores were recorded. The patient, the operator and the observer were blinded to the applied medication. Post operatively, patients‘ and parents‘ satisfaction were assessed by Visual Analogue Score and a questionnaire respectively. The P-value was set at 0.05 for significance level.

Findings

There were no significant differences in physiologic factors in the medication groups at time 0, 10, 20, 30 minutes and discharge. There was also no significant difference between the two groups in behavioral parameters. The majority of parents rated both sedative agents as “effective” or “very effective” and their children mostly were without anxiety or with minor anxiety.

Conclusion

Buccal midazolam may be safely and efficiently used in sedation of pediatric dental patients.     

Pharmacodynamics of chloral hydrate in former preterm infants

The aim of this study was to document the pharmacodynamics of chloral hydrate in former preterm infants at term post-conception age. The degree of sedation (COMFORT), feeding behaviour and cardiorespiratory events (bradycardic events, apnoeas) before and after administration of chloral hydrate (oral, 30 mg/kg) were prospectively evaluated in former preterm infants during procedural sedation. Characteristics at birth, during neonatal stay and at inclusion were collected. Paired Wilcoxon and McNemar tests were used to study the impact of chloral hydrate. Characteristics of infants who displayed severe bradycardic events were compared to infants in whom no bradycardic events were recorded (Mann Whitney U, Fischers exact). A significant increase in sedation (decrease COMFORT scale) was observed up to 12 h after administration. There was a minor but significant decrease in oral intake (161 to 156 ml/kg/day, P <0.01). A significant increase in the number of bradycardic events (<80/min: 38 to 82 events, of which <70/min: 30 to 79 of which <60/min: 15 to 45; at least P <0.01) and in the duration of the most severe bradycardic event (8–12.5 s) was observed. Therefore, further inclusion was stopped when 26 neonates were included. Infants who displayed severe bradycardic (<60/min) events ( n =13) after administration of chloral hydrate had a lower gestational age at birth without difference in post-conception age at inclusion. Conclusion:Chloral hydrate was associated with an increase in unintended side-effects in former preterm infants, likely reflecting population specific pharmacodynamics and kinetics of chloral hydrate.     

Sedation and analgesia for brief diagnostic and therapeutic procedures in children

The number of diagnostic and therapeutic procedures done outside of the operating room and the intensive care unit has increased substantially in recent years. In parallel, the management of acute pain and anxiety in children undergoing therapeutic and diagnostic procedures has developed considerably in the past two decades. The primary goal of procedural sedation and analgesia is the safe and efficacious control of emotional distress and pain. The availability of non-invasive monitoring, short-acting opioids and sedatives has broadened the possibilities of sedation and analgesia in children in diverse settings. While most of these procedures themselves pose little risk to the child, the administration of sedation or analgesia may add substantial risk to the patient. This article reviews the current status of sedation and analgesia for invasive and non-invasive procedures in children providing an evidence-based approach to several topics of importance, including patient assessment, personnel requirements, equipment, monitoring, and drugs.     

伴中央-颞区棘波的儿童良性癫35例临床和脑电图特征

目的探讨伴中央-颞区棘波的儿童良性癫(BECTS)的临床和脑电图(EEG)特征。方法对2003年7月-2008年12月在本院癫门诊就诊的35例BECTS患儿的临床资料、EEG结果、药物治疗反应及预后进行回顾性分析。结果本组35例BECTS患儿的起病年龄为2.5～14.0岁,其中6～10岁为发病高峰(62.9%)。表现为局限性发作22例:一侧面部抽搐、流涎、咽喉发声、肢体强直或阵挛,部分继发全面性强直阵挛发作。仅表现为全面强直阵挛发作者13例。发作与睡眠密切相关,26例仅在睡眠期(包括午睡)发作,且多出现于入睡后不久或清醒前。所有患儿发作间期EEG背景活动正常,可见一侧或双侧中央-颞区尖波/棘波,发放频度于入睡后明显增加,睡眠期EEG监测可提高阳性率。应用小剂量抗癫药物单药治疗疗效好,25例在用药3～4个月停止发作,本组33例已停止发作,停止发作的年龄为4.5～16.0岁,12例已停止药物治疗。结论BECTS多发生于学龄期儿童,表现为局限性发作,也可全面泛化,发作与睡眠密切相关,睡眠期EEG监测具有重要诊断价值,EEG表现为一侧或双侧中央-颞区尖波/棘波,小剂量抗癫药物单药治疗反应良好,预后一般良好。     

Comparison of 0.5% Centbucridine and 2% Lignocaine as Local Anesthetic Agents for Dental Procedures in Children: A Randomised Controlled Trial

To compare 0.5% centbucridine and 2% lignocaine (with adrenaline) as local anesthetic agents for dental treatment procedures in 12 to 14 y old children. A split mouth, triple blind randomised controlled trial design was adopted for this study. Fifty six children between 12 to 14 y of age requiring bilateral administration of inferior alveolar nerve block (IANB) were recruited for this study. The mandibular quadrants were randomly allotted to the drug being administered. Standardised protocol for local anesthesia administration was used. The primary outcomes assessed were onset, duration and depth of anesthesia using the pre-validated Visual Analog scale and effect on perioperative pulse rate using a pulse oximeter. There was no significant difference between centbucridine and lignocaine with respect to their mean onset [(105.181 and 99.727 s respectively), (p = 0.647)], duration of action [(91.931 and 91.613 min respectively), (p = 0.931)] and depth of anesthesia at 10, 30 and 60 min. Centbucridine showed a statistically significant drop in the pulse rate at 10 (p < 0.001) and 30 min (p < 0.001). There was no significant difference between 0.5% centbucridine and 2% lignocaine with respect to onset, duration and depth of anesthesia.     

复杂部分性癫痫持续状态的临床与脑电图特征

目的　通过对复杂部分性癫痫持续状态 (CPSE)的临床分析 ,阐述小儿CPSE的临床特征、诊断与治疗。方法　对该院 1 7例CPSE患儿的临床过程、脑电图及抗癫痫治疗等资料进行分析。结果 1 7例CPSE患儿起病年龄为 3～ 1 2岁 ,临床发作持续时间为 1h～ 3.5周 ;78%的患儿有明确的病因 ,CPSE临床表现多样 ,所有病例均有意识障碍 ,同时伴有不同程度的精神和行为异常 ,发作期脑电图主要以基本电活动变慢伴颞部局灶性慢波或痫样放电的持续或周期性发放为特征 ,经抗癫痫药物等治疗 ,1 1例患儿持续发作完全控制 ,4例持续状态控制 ,仅有部分性发作 ,2例未能控制。结论　意识障碍伴精神和行为异常为CPSE的临床特征 ,发作期及发作间期脑电图检查可明确诊断 ,对CPSE患儿应予以及时诊断和处理。     

地佐辛用于儿童术后镇痛有效性和安全性的随机对照试验

背景：新型阿片受体激动 拮抗剂地佐辛用于儿童术后镇痛的研究报道甚少,且没有公认的儿童用药参考剂量。 目的：探讨地佐辛应用于儿童术后镇痛的有效性和安全性,为其用于儿童术后镇痛提供合适的参考剂量。 设计单中心RCT。 方法：纳入在重庆医科大学附属儿童医院行先天性心脏病（CHD）手术后直接转入PICU的患儿,手术时年龄>28 d,术前美国麻醉医师协会（ASA）分级Ⅲ～Ⅳ级。按随机数字表法生成随机分组方案,装入密闭信封保存;由当班的PICU医生负责入组,由管床护士执行干预。随机分为5组,试验组患儿在术后持续静脉泵入低剂量（D1组）、中剂量（D2组）或高剂量（D3组）地佐辛,对照组泵入舒芬太尼（SF组）或吗啡（M组）,观察术后疼痛评分和镇静评分。未对结局指标观察人员和数据分析人员施盲。共同干预措施：入PICU后使用有创呼吸机辅助通气,予对症处理和咪达唑仑镇静。D1、D2、D3组分别予地佐辛20、30、40 μg·kg-1·h-1,SF组予舒芬太尼0.08 μg·kg-1·h-1,M组予吗啡20 μg·kg-1·h-1,均为静脉泵注。疼痛评分包括脸谱疼痛评分法（FPS）和CRIES评分法,镇静评分包括Ramsay评分法和舒适行为量表（Comfort B评分）,均由PICU专科护士完成。 主要结局指标:术后1 h、4 h、8 h、12 h和24 h的镇痛/镇静满意度百分比。 结果:共152例CHD患儿入组,D1、D2、D3、SF和M组分别为30、30、31、31和30例,均完成设计的干预和观察。5组患儿年龄、体重、性别、体外循环时间、危重症评分（PCIS）和术前ASA分级差异均无统计学意义。①FPS评分：D2组术后24 h,D3组术后4 h、24 h镇痛满意度高于M组;CRIES评分：D1、D2组术后1 h、4 h,D3组术后4 h、24 h镇痛满意度高于M组;Ramsay评分： D2、D3组术后1 h、4 h镇静满意度高于M组;Comfort B评分： D1组术后4 h、12 h,D2组术后1 h、4 h,D3组术后1 h、4 h、12 h镇静满意度高于M组;差异均有统计学意义。4种评分D组和SF组的镇痛/镇静满意度差异均无统计学意义。②5组术后各时间点生命体征及相关指标差异均无统计学意义;D1、D2组追加镇静/镇痛药物的比例低于M组和SF组,差异均有统计学意义。M组观察到2例低血压及1例呼吸抑制。 结论:地佐辛应用于儿童CHD术后的镇痛效果优于吗啡,与舒芬太尼效果相当,且不良反应少。     

Efficacy and Safety of <Emphasis Type="Italic">Saccharomyces boulardii</Emphasis> in Acute Childhood Diarrhea: A Double Blind Randomised Controlled Trial

Objective  

To see the efficacy and safety of 250 mg of Saccharomyces boulardii twice daily for 5 d in acute childhood diarrhea.     

Efficacy and Safety of Orally Administered Intravenous Midazolam Versus a Commercially Prepared Syrup

Background:

Among different categories of sedative agents, benzodiazepines have been prescribed for more than three decades to patients of all ages. The effective and predictable sedative and amnestic effects of benzodiazepines support their use in pediatric patients. Midazolam is one of the most extensively used benzodiazepines in this age group. Oral form of drug is the best accepted route of administration in children.

Objectives:

The purpose of this study was to compare the efficacy and safety of a commercially midazolam syrup versus orally administered IV midazolam in uncooperative dental patients. Second objective was to determine whether differences concerning sedation success can be explained by child‘s behavioral problems and dental fear.

Patients and Methods:

Eighty eight uncooperative dental patients (Frankl Scales 1,2) aged 3 to 6 years, and ASA I participated in this double blind, parallel randomized, controlled clinical trial. Midazolam was administered in a dose of 0.5 mg/kg for children under the age 5 and 0.2 mg/kg in patients over 5 years of age. Physiologic parameters including heart rate, respiratory rate, oxygen saturation and blood pressure were recorded. Behavior assessment was conducted throughout the course of treatment using Houpt Sedation Rating Scale and at critical moments of treatment (injection and cavity preparation) by North Carolina Scale. Dental fear and behavioral problems were evaluated using Child Fear Schedule Survey-Dental Subscale (CFSS-DS), and Strength and Difficulties Questionnaire (SDQ). Independent t-test, Chi-Square, and Pearson correlation were used for statistical analysis.

Results:

Acceptable overall sedation ratings were observed in 90% and 86% of syrup and IV/Oral group respectively; Chi-Square P = 0.5. Other domains of Houpt Scale including: sleep, crying and movement were also not significantly different between groups. Physiological parameters remained in normal limits during study without significant difference between groups.

Conclusions:

“Orally administered IV midazolam” preparation can be used as an alternative for commercially midazolam syrup.     

Doppler Pressure Gradient Estimation in Children Accuracy, Effect of Activity and Exercise, and the Need for Sedation during Examination

ABSTRACT. Noninvasive estimation of pressure drop has been shown to be an accurate and useful application of Doppler echocardiography. Most accuracy series have used patient-sedated catherization gradient measurements as the standard of reference. Doppler gradient estimates, however, are commonly made without sedation of the patient when hemodynamics may differ from those present at catheterization. We questioned whether (1) "unsedated" Doppler gradient estimates would correlate in a useful way with "sedated" catheter measurements, (2) Doppler gradient estimates would vary with patient activity, exercise or crying, and (3) Doppler gradient estimates made using chloral hydrate sedation would prove useful in predicting sedated catheter measurements. Twenty-five infants and children were examined under conditions 1 and 2 above, and 20 under condition 3. Sedated Doppler estimates, performed at the time of catheterization corresponded closely with catheter measurements ( r =0.97, SEE=4.8), confirming the accuracy of the Doppler method. Gradients estimated by Doppler without sedation, or with activity, correlated poorly with sedated catheter measurements (SEE=16.2, SEE=34.9, respectively). Use of chloral hydrate sedation for Doppler estimates resulted in good correlation with subsequent sedated catheter measurements. The results demonstrate marked increases in noninvasive Doppler pressure gradient estimates under conditions other than sedation. Clinicians tend to think in terms of sedated catheter-gradients as the standard of reference for evaluation of severity and need for surgery. Ultrasonic data can only be used if Doppler estimates are performed under similar physiologic conditions; in children this requires sedation.     

Clinical Trial of Vigabatrin as Adjunctive Therapy in Children with Refractory Epilepsy

Objective

Approximately one-third of all children with epilepsy do not achieve complete seizure improvement. This study evaluated the efficacy of Vigabatrin in children with intractable epilepsy.

Methods

From November 2011 to October 2012, 73 children with refractory epilepsy (failure of seizure control with the use of two or more anticonvulsant drugs) who were referred to the Children’s Medical Center and Mofid Children’s Hospital were included in the study. The patients were treated with Vigabatrin in addition to their previous medication, and followed-up after three to four weeks to determine the daily frequency, severity, and duration of seizures in addition to any reported side effects.

Findings

Of the 67 children, 41 (61.2%) were males and 26 (38.8%) females, their age ranging from three months to 13 years with an average of 3.1 [standard deviation (SD), 2.6] years. The mean daily frequency of seizures at baseline was 6.61 (SD, 5.9) seizures per day. Vigabatrin reduced the seizure frequency ≤2.9 (SD, 5.2) (56% decline) and 3.0 (SD, 5.3) (54.5% decline) per day after three and six months of treatment, respectively. A significant difference was observed between seizure frequencies at three (P<0.001) and six months (P<0.001) after Vigabatrin initiation compared with the baseline. Somnolence [3 (4.5%)], horse laugh [1 (1.5%)], urinary stones [1 (1.5%)], increased appetite [1 (1.5%)], and abnormal electroretinographic pattern [3 (4.5%)] were the most common side effects in our patients.

Conclusion

This study confirms the short-term efficacy and safety of Vigabatrin in children with refractory epilepsies.     

白三烯受体拮抗剂在儿童支气管哮喘并变应性鼻炎的临床研究

目的评价白三烯受体拮抗剂在治疗儿童支气管哮喘(哮喘)与变应性鼻炎(AR)的临床效果。方法选择2005年10月至2006年4月在我院儿科门诊诊断为哮喘并AR的患儿100例,随机分3组:口服孟鲁司特组(1组,吸入布地奈德都保加口服孟鲁司特5 mg,每晚1次);鼻内吸入激素组(2组,吸入布地奈德都保加鼻内吸入布地奈德鼻喷剂64μg,每日1次);对照组(仅吸入布地奈德都保)。观察期为6个月,每隔4周随访,记录患儿的临床症状评分;在治疗前及治疗后第8、24周检查肺功能,记录1秒钟用力呼气量占正常预计值的百分比(FEV1%)、鼻内分泌物嗜酸性细胞数、速效β2受体激动剂使用次数、所用药物分值以及哮喘急性发作次数及无症状天数。结果与治疗前比较,1组和2组明显降低了哮喘日间、夜间症状评分与鼻炎症状评分,差异均有统计学意义(P<0.05)。1组在哮喘日间、夜间症状评分与鼻炎症状评分、速效β2受体激动剂使用次数、所用药物分值与对照组比较,差异有统计学意义(P<0.05),而与2组比较,差异无统计学意义(P>0.05)。但1组在改善FEV1%、增加无症状天数及减少哮喘急性发作的次数均优于2组(P<0.05、P<0.001、P<0.0...     

Comparison of Acetaminophen and Ketoprofen in Febrile Children: A Single Dose Randomized Clinical Trial

Objective  

To compare ketoprofen with acetaminophen in febrile children in terms of proportion of achieved temperatures below 37.8°C and time of temperature reduction.     

Pindolol and Methylphenidate in Children with Attention-Deficit Hyperactivity Disorder. Clinical Efficacy and Side-Effects

The purpose of this study was to examine the efficacy and side-effects of pindolol, a β-blocker, in children with attention-deficit hyperactivity disorder (ADHD). Fifty-two ADHD children, 7–13 years old, participated in a prospective double-blind placebo-controlled comparison of pindolol and methylphenidate (MPH). Active treatment was pindolol and MPH: pindolol 20 mg b.i.d. or MPH 10 mg b.i.d. for 4 weeks. The outcome was assessed on the basis of the Abbreviated Conners Rating Scales (ACRS) completed by parents, teachers, and by a psychologist during psychological testing. Pindolol treatment was associated with a higher incidence of paraesthesias and with more intense nightmares and hallucinations than MPH or placebo treatment. These side-effects led to an interim change in design by ending pindolol treatment after 32 participants. Pindolol proved to be just as effective as MPH in decreasing hyperactivity and conduct problems at home, and hyperactivity problems at school. Pindolol, however, had less therapeutic effects than MPH during psychological testing, and failed to affect conduct problems in school. In sum, pindolol was modestly effective in the treatment of ADHD. Safety concerns on troubling side-effects clearly limit the use of it.