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pediatric double blind

Ahmet Baştürk, Reha Artan, Aygen Yılmaz
BACKGROUND/AIMS: Irritable bowel syndrome (IBS) is an important health problem that presents serious social burdens and high costs. Our study investigated the efficacy of synbiotic (Bifidobacterium lactis B94 with inulin), probiotic (B. lactis B94), and prebiotic (inulin) treatment for IBS in a pediatric age group. MATERIAL AND METHODS: This study was randomized, double-blind, controlled, and prospective in design and included 71 children between the ages of 4 and 16 years who were diagnosed with IBS according to the Rome III criteria...
September 2016: Turkish Journal of Gastroenterology: the Official Journal of Turkish Society of Gastroenterology
Terence A Ketter, Suresh Durgam, Ronald Landbloom, Mary Mackle, Xiao Wu, Maju Mathews
BACKGROUND: Asenapine (ASN) is approved in the United States as monotherapy and adjunctive therapy (to lithium or valproate) in adults with bipolar mania, and as monotherapy in pediatric patients with bipolar mania. This is the first long-term study evaluating safety and tolerability of ASN fixed doses in this population. METHODS: After completing a 3-week, randomized, placebo (PBO)-controlled acute trial, patients could enroll in this 26-week, fixed-dose (5 or 10mg twice daily), double-blind extension study...
October 14, 2016: Journal of Affective Disorders
Aris Oates, Kelly A Benedict, Karen Sun, Paul R Brakeman, Jessica Lim, Cynthia Kim
Evaluate laser acupuncture as an adjuvant therapy in pain management during percutaneous kidney biopsy procedure in children and adolescents. This prospective, double-blinded, randomized controlled trial enrolled patients aged 7-26 years admitted to a children's hospital for percutaneous kidney biopsy. Patients received laser acupuncture to treatment points (acupuncture group) or sham points (control group) prior to the procedure. Laser delivered a dose of 42 J/cm over 10 acupoints. Patients and parents rated the pain during and after the biopsy, and change in pain scores were calculated for each patient...
September 29, 2016: Pain
Chandni Sinha, Bindey Kumar, Umesh Kumar Bhadani, Ajeet Kumar, Amarjeet Kumar, Alok Ranjan
BACKGROUND: Caudal block is a reliable regional analgesic technique for pediatric urogenital surgeries. Various adjuvants have been tried to enhance the duration of action of bupivicaine. Though clonidine is extensively used as an adjuvant in caudal anaesthesia, it can have troublesome adverse effects like bradycardia, hypotension and sedation. Lately dexamethasone has become popular as an adjuvant in paediatric caudals due to its safety profile. AIM: The aim of this study was to compare dexamethasone and clonidine coadministered with bupivicaine caudally in paediatric patients undergoing urogenital surgeries in terms of analgesia and adverse effects...
September 2016: Anesthesia, Essays and Researches
Shlomo Chamny, Dan Miron, Nadia Lumelsky, Hana Shalev, Elana Gazal, Rita Keynan, Avner Shemer, Dov Tamarkin
BACKGROUND: Currently available treatment options for impetigo are limited by either systemic side effects (for oral therapy) or lack of ease of use (for topical ointment). A novel foam formulation of minocycline for topical use may improve convenience and treatment utilization for pediatric patients with impetigo. OBJECTIVE: To evaluate the safety and efficacy of topically applied minocycline foam (FMX-102 1% and 4%) in the treatment of impetigo and to determine the optimal therapeutic active ingredient concentration...
October 1, 2016: Journal of Drugs in Dermatology: JDD
Niran J Amar, Tulin Shekar, Tracey A Varnell, Anish Mehta, George Philip
OBJECTIVES: Mometasone furoate (MF), delivered via dry-powder inhaler (DPI) QD in the evening (PM), is a treatment option for pediatric patients with asthma. We evaluated MF delivered via a metered-dose inhaler (MDI), in children ages 5-11 years with persistent asthma. METHODS: This was a 12-week double-blind, double-dummy, placebo-controlled trial. Pateints were randomized to the following treatments: MF-MDI 50 mcg BID, MF-MDI 100 mcg BID, MF-MDI 200 mcg BID, MF-DPI 100 mcg QD PM, and placebo...
October 14, 2016: Pediatric Pulmonology
David Smith, High Cheek, Brenda Denson, Christopher M Pruitt
OBJECTIVE: Intranasal (IN) midazolam is a commonly prescribed medication for pediatric sedation and anxiolysis. One of its most frequently-encountered adverse effects is discomfort with administration. While it has been proposed that premedicating with lidocaine reduces this undesirable consequence, this combination has not been thoroughly researched. The objective of our study was to assess whether topical lidocaine lessens the discomfort associated with IN midazolam administration. METHODS: This was a double-blinded, randomized, placebo-controlled trial performed in an urban, academic pediatric emergency department...
October 14, 2016: Academic Emergency Medicine: Official Journal of the Society for Academic Emergency Medicine
Lan Chi Vo, Christopher Snyder, Courtney McCracken, Christopher J McDougle, James T McCracken, Michael G Aman, Elaine Tierney, L Eugene Arnold, Daniel Levi, Michael Kelleman, Deirdre Carroll, John Morrissey, Benedetto Vitiello, Lawrence Scahill
OBJECTIVES: Risperidone is approved for the treatment of serious behavioral problems in children with autism spectrum disorder (ASD). This study examined the effects of risperidone on cardiac conduction in children with ASD. METHODS: Data were collected from an 8-week, five-site trial conducted by the Research Units on Pediatric Psychopharmacology Autism Network. Children (age 5-17 years) were randomly assigned to risperidone (n = 49) or placebo (n = 52) under double-blind conditions...
October 11, 2016: Journal of Child and Adolescent Psychopharmacology
Ronen Bar-Yoseph, Nir Kugelman, Galit Livnat, Michal Gur, Fahed Hakim, Vered Nir, Lea Bentur
BACKGROUND AND OBJECTIVES: Asthma is a chronic inflammatory disorder requiring intermittent or continuous anti-inflammatory therapy. Patients often turn to alternative treatments as complements or replacements to conventional treatments. We aimed to evaluate the effect of salt room chambers (halotherapy) on bronchial hyper-responsiveness (BHR), fractional exhaled nitric oxide (FeNO), and quality of life in children with asthma. PATIENTS AND METHODS: Children aged 5-13 years with a clinical diagnosis of mild asthma not receiving anti-inflammatory therapy...
October 10, 2016: Pediatric Pulmonology
Michael Glenn O'Connor, Kelly Thomsen, Rebekah F Brown, Michael Laposata, Adam Seegmiller
BACKGROUND: Airway inflammation is a significant contributor to the morbidity of cystic fibrosis (CF) disease. One feature of this inflammation is the production of oxygenated metabolites, such as prostaglandins. Individuals with CF are known to have abnormal metabolism of fatty acids, typically resulting in reduced levels of linoleic acid (LA) and docosahexaenoic acid (DHA). METHODS: This is a randomized, double-blind, cross-over clinical trial of DHA supplementation with endpoints of plasma fatty acid levels and prostaglandin E metabolite (PGE-M) levels...
October 2016: Prostaglandins, Leukotrienes, and Essential Fatty Acids
Saro H Armenian, Melissa M Hudson, Ming Hui Chen, Steven D Colan, Lanie Lindenfeld, George Mills, Aida Siyahian, Sarah Gelehrter, Ha Dang, Wendy Hein, Daniel M Green, Leslie L Robison, F Lennie Wong, Pamela S Douglas, Smita Bhatia
BACKGROUND: Anthracyclines are widely used in the treatment of childhood cancer. One of the well-recognized side-effects of anthracycline therapy is dose-dependent cardiomyopathy that may progress to heart failure (HF) years after completion of cancer-directed therapy. This study will evaluate the efficacy of low-dose beta-blocker (carvedilol) for HF risk reduction in childhood cancer survivors at highest risk for HF. The proposed intervention has the potential to significantly reduce chronic cardiac injury via interruption of neurohormonal systems responsible for left ventricular (LV) remodeling, resulting in improved cardiac function and decreased risk of HF...
October 4, 2016: BMC Cardiovascular Disorders
Andrea L Conroy, Michael Hawkes, Chloe R McDonald, Hani Kim, Sarah J Higgins, Kevin R Barker, Sophie Namasopo, Robert O Opoka, Chandy C John, W Conrad Liles, Kevin C Kain
Background.  Host responses to infection are critical determinants of disease severity and clinical outcome. The development of tools to risk stratify children with malaria is needed to identify children most likely to benefit from targeted interventions. Methods.  This study investigated the kinetics of candidate biomarkers of mortality associated with endothelial activation and dysfunction (angiopoietin-2 [Ang-2], soluble FMS-like tyrosine kinase-1 [sFlt-1], and soluble intercellular adhesion molecule-1 [sICAM-1]) and inflammation (10 kDa interferon γ-induced protein [CXCL10/IP-10] and soluble triggering receptor expressed on myeloid cells-1 [sTREM-1]) in the context of a randomized, double-blind, placebo-controlled, parallel-arm trial evaluating inhaled nitric oxide versus placebo as adjunctive therapy to parenteral artesunate for severe malaria...
September 2016: Open Forum Infectious Diseases
Jiyalal Harnot, Sanjay Verma, Sunit Singhi, Naveen Sankhyan, Naresh Sachdeva, Bhavneet Bharti
OBJECTIVE: To compare the efficacy and safety of 300,000 and 600,000 IU vitamin-D single-oral dose for the treatment of vitamin-D deficiency (VDD) in young children (3 mo - 3 y). METHODS: This double-blind randomized control trial (Clinical Trail Registration-CTRI/2012/05/002621) was conducted in the Pediatric out-patient department (OPD) at a tertiary-care referral hospital. Children (3 mo - 3 y) with clinical/radiological features suggestive of VDD were screened; those found to be having 25(OH)D below 15 ng/ml and meeting inclusion and exclusion criteria's were enrolled after taking informed consent...
September 29, 2016: Indian Journal of Pediatrics
Karthik Narayanan Ramaswamy, Sunit Singhi, Muralidharan Jayashree, Arun Bansal, Karthi Nallasamy
OBJECTIVE: We compared efficacy of dopamine and epinephrine as first-line vasoactive therapy in achieving resolution of shock in fluid-refractory hypotensive cold septic shock. DESIGN: Double-blind, pilot, randomized controlled study. SETTING: Pediatric emergency and ICU of a tertiary care teaching hospital. PATIENTS: Consecutive children 3 months to 12 years old, with fluid-refractory hypotensive septic shock, were enrolled between July 2013 and December 2014...
September 23, 2016: Pediatric Critical Care Medicine
Kyle A Williams, Susan E Swedo, Cristan A Farmer, Heidi Grantz, Paul J Grant, Precilla D'Souza, Rebecca Hommer, Liliya Katsovich, Robert A King, James F Leckman
OBJECTIVE: Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) are hypothesized to occur as a result of cross-reactive antibodies produced in response to group A streptococcal infections. Previous research suggests that immunomodulatory therapies, such as intravenous immunoglobulin (IVIG), may lead to rapid and sustained symptom improvement in patients with PANDAS. METHOD: A total of 35 children meeting criteria for PANDAS and moderate to severe obsessive-compulsive disorder (OCD) were enrolled in a randomized-entry, double-blind, placebo-controlled, 6-week trial of IVIG (1 g/kg/day on 2 consecutive days), followed by optional open-label treatment for nonresponders, with follow-up at 12 and 24 weeks...
October 2016: Journal of the American Academy of Child and Adolescent Psychiatry
Roberta Delasta Lazzari, Fabiano Politti, Stefany Ferreira Belina, Luanda André Collange Grecco, Cibele Almeida Santos, Arislander Jonathan Lopes Dumont, Jamile Benite Palma Lopes, Veronica Cimolin, Manuela Galli, Cláudia Santos Oliveira
The authors' aim was to investigate the effects of continuous transcranial direct current stimulation (tDCS) combined with virtual reality training on static and functional balance in children with cerebral palsy (CP). Twenty children with CP (6 girls and 14 boys; M age = 7 years 6 months ± 2 years) were randomly allocated to two groups. The experimental group received active tDCS and the control group received sham stimulation during the 10 sessions of virtual reality mobility training protocols. The children were evaluated on 3 occasions (preintervention, postintervention, and 1-month follow-up)...
September 20, 2016: Journal of Motor Behavior
Todd Milbrandt, Richard Kryscio, Ryan Muchow, Janet Walker, Vishwas Talwalkar, Henry Iwinski
BACKGROUND: Idiopathic clubfoot treatment is treated by manipulation and casting utilizing the Ponseti technique which can make the infant fussy and irritable. The goal of this study was to determine which intervention could decrease this pain response in infants undergoing Ponseti casting for idiopathic clubfeet. Our hypothesis was that the administration of oral sucrose solution or milk would be the most effective in accomplishing that goal. METHODS: We conducted a double-blinded randomized controlled trial at a tertiary pediatric orthopaedic center on 33 children (average age=17...
September 15, 2016: Journal of Pediatric Orthopedics
Zachary Farhood, Adrian A Ong, Christopher M Discolo
INTRODUCTION: Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcus (PANDAS) is a rare but important condition for pediatric otolaryngologists to recognize. Several treatment options exist including tonsillectomy, antibiotic treatment/prophylaxis, intravenous immunoglobulin (IVIG), and psychiatric medications/therapy. METHODS: A systematic review of the PubMed, EMBASE, and Scopus databases was performed searching for articles that focused exclusively on the aforementioned treatment modalities in the PANDAS population...
October 2016: International Journal of Pediatric Otorhinolaryngology
Mohammad Hossein Dadgarnia, Mohammad Ali Aghaei, Saeid Atighechi, Nasim Behniafard, Mohammad Reza Vahidi, Mojtaba Meybodian, Vahid Zand, Maryam Vajihinejad, Abdollah Ansari
OBJECTIVE: Although tonsillectomy is one of the most common surgeries performed in pediatric, it has potential major complications such as pain and bleeding. This study aimed to compare the bleeding and pain after tonsillectomy in bipolar electrocautery tonsillectomy versus cold dissection. METHODS: This double blind clinical trial was conducted on 70 pediatric patients who were candidate of tonsillectomy. Patients were divided into two groups of including bipolar cautery (BC) and cold dissection (CD)...
October 2016: International Journal of Pediatric Otorhinolaryngology
Khaled R Al-Zaben, Ibraheem Y Qudaisat, Aboud N Alja'bari, Omar A Ababneh, Al-Motassem M Yousef, Abdulrahman M Al-Shudifat
STUDY OBJECTIVES: The aim of this study was to compare the effects of caudal and intravenous (IV) dexmedetomidine (1 μg/kg) on postoperative analgesia after caudal bupivacaine in pediatric patients undergoing lower abdominal and perineal surgeries. DESIGN: A randomized controlled double-blind study. SETTING: University-affiliated teaching hospital. PATIENTS: Seventy-five American Society of Anesthesiologists I children, aged 1 to 6 years...
September 2016: Journal of Clinical Anesthesia
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