Circulating levels of incretin hormones and amylin in the fasting state and after oral glucose in GH-deficient patients before and after GH replacement: a placebo-controlled study

OBJECTIVE: Hyperinsulinemia in association with GH excess is considered a compensatory response to insulin resistance, but the possibility of alternative insulinotropic mechanisms has not been investigated in vivo. It is also unknown how GH influences the secretion from pancreatic beta-cells of amylin, a peptide which regulates prandial glucose homeostasis and may be linked to development of beta-cell dysfunction. We therefore measured plasma concentrations of two gut insulinotropic hormones, glucagon-like peptide 1 (GLP-1) and glucose-dependent insulin-releasing peptide (GIP), and total as well as non-glycosylated amylin, in 24 GH-deficient adults before and after 4 months of GH replacement (daily evening injections of 2 IU GH/m). DESIGN: Double-blind, placebo-controlled, parallel study. METHODS: All participants underwent an oral glucose tolerance test (OGTT) at 0 and 4 months. RESULTS: A 33% suppression of fasting GLP-1 concentrations was measured in the GH group at 4 months (P=0.02), whereas a non-significant increase occurred in the placebo group (P=0.08). Fasting levels of GIP and amylin did not change significantly after 4 months in either group. The incremental response in GLP-1 during the OGTT was significantly lower after GH treatment as compared with both baseline (P=0.02) and the response in the placebo group (P=0. 03). The stimulation of GIP secretion following OGTT was similar on all occasions. The OGTT-induced incremental response in non-glycosylated amylin was moderately elevated after GH treatment as compared with placebo (P=0.05). Plasma concentrations of glucose and insulin, both in the fasting state and after the OGTT, were higher after GH treatment, but the ratio between amylin and insulin remained unchanged. CONCLUSIONS: GH-induced hyperinsulinemia is accompanied by proportionate elevations in amylin concentrations and a blunting of gut GLP-1 secretion. The mechanisms underlying the suppression of GLP-1 remain to be elucidated.

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Efficacy of probiotics in irritable bowel syndrome: A randomized, double blind placebo-controlled study

Bangabandhu Sheikh Mujib Medical University Journal ◽

10.3329/bsmmuj.v6i1.29020 ◽

2016 ◽

Vol 6 (1) ◽

pp. 21 ◽

Cited By ~ 1

Author(s):

Md. Zahidur Rahman ◽

Mohammad Shoaib Chowdhury ◽

Mohammad Asadur Rahman ◽

Shohely Parveen ◽

Rajib Barua ◽

...

Keyword(s):

Irritable Bowel Syndrome ◽

Placebo Group ◽

Intestinal Microbiota ◽

Therapeutic Potential ◽

Intestinal Barrier ◽

Controlled Study ◽

Double Blind ◽

Before And After ◽

Irritable Bowel

Background: Gut flora have important trophic effects on intestinal epithelia and on immune structure and fonction.They also protect colonized host against invasion by alien microbes.Recent research suggests that an imbalance of the intestinal microbiota and a dysfunctional intestinal barrier might trigger irritable bowel syndrome (lBS). As probiotics have been reported to restore the intestinal microbiota and the gut barrier, the therapeutic potential of probiotics within IBS became of strong interest. Objectives: To assess the efficacy of probiotics in lBS. Methods: Patients of 15 to 60 years old and both sexes were included f om the out patient department (OPD) of gastroenterology, Bangabandhu Sheikh Mujib Medical University (BSMMU). A validated lBS-QOL instmment consisted of 34 questions used to assess improvement of quality of Iife before and after treatment. A total of 65 diarrhoea predominant LBS patients were randomised to receive either probiotics(n-33) or placebo(n-32) twice daily frir 6 weeks.Results: At the end of 6 weeks therapy, improvement in various symptoms(abclominal pain, stool frequency, consistency and 11atulence) in probiotics group was statistically significant. Mean QOL score before treatment was 103 in probiotics group and I 06 in placebo group. After 6 weeks of treatment mean QOL score was 82 in probiotics group and I 02.58 in placebo group. No side effects of the therapeutic agents were observed in any patient during the trial. Conclusions: Probiotics effectively alleviates global IBS and improves TBS symptoms simultaneously with an improvement of quality of life.

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Failure of prophylactically administered phenytoin to prevent early posttraumatic seizures

Journal of Neurosurgery ◽

10.3171/jns.1983.58.2.0231 ◽

1983 ◽

Vol 58 (2) ◽

pp. 231-235 ◽

Cited By ~ 78

Author(s):

Byron Young ◽

Robert P. Rapp ◽

J. A. Norton ◽

Dennis Haack ◽

Phillip A. Tibbs ◽

...

Keyword(s):

Placebo Group ◽

Plasma Concentrations ◽

Controlled Study ◽

Early Administration ◽

Double Blind ◽

Content Type ◽

Significant Difference ◽

Oral Doses ◽

Early Seizure ◽

Posttraumatic Seizures

✓ A randomized double-blind placebo-controlled study was carried out to determine whether phenytoin administered soon after injury lessens the incidence of epilepsy in the 1st week after severe head trauma. In this study, 244 patients were randomized into either a phenytoin or placebo group. The patients in the phenytoin group were administered phenytoin intravenously or intramuscularly within 24 hours of hospital admission. Patients in the placebo group received intravenous or intramuscular diluent. The patients were switched from parenterally administered phenytoin or placebo as soon as oral doses could be tolerated. Over 78% of the phenytoin patients had plasma concentrations of at least 10 µg/ml at 1, 3, and 7 days after injury. There was no significant difference in the percentage of patients having early seizures in the treated and placebo groups (p = 0.99). There was no significant difference in the interval from injury to first seizure between the treated and placebo groups (p = 0.41). The early administration of phenytoin did not lessen the occurrence of seizures in the 1st week after head injury. Since the effectiveness of seizure prophylaxis has not been established, the authors suggest that anticonvulsant drugs be administered only after an early seizure has occurred.

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Effect of Dietary Supplementation with a Natural Extract of Sclerocarya birrea on Glycemic Metabolism in Subjects with Prediabetes: A Randomized Double-Blind Placebo-Controlled Study

Nutrients ◽

10.3390/nu13061948 ◽

2021 ◽

Vol 13 (6) ◽

pp. 1948

Author(s):

Desirée Victoria-Montesinos ◽

Maravillas Sánchez-Macarro ◽

José Antonio Gabaldón-Hernández ◽

María Salud Abellán-Ruiz ◽

María Querol-Calderón ◽

...

Keyword(s):

Placebo Group ◽

Cell Function ◽

Antidiabetic Activity ◽

Controlled Study ◽

Oral Glucose ◽

Double Blind ◽

Natural Extract ◽

Double Blind Placebo ◽

Sclerocarya Birrea ◽

Experimental Group

A randomized, double-blind, placebo-controlled study was conducted with the primary objective of assessing the effect of a natural extract of Sclerocarya birrea on glucose metabolism in subjects with prediabetes. The duration of the study was 90 days. Thirty-three subjects assigned to the experimental group (daily ingestion of 100 mg of the nutraceutical product) and 34 assigned to the placebo group completed the study. There were 36 men and 31 women with a mean age of 32.3 ± 14.1 years. In the area under the curve (AUC) of the oral glucose tolerance test (OGTT), statistically significant decreases in the experimental group at 40 and 90 days as compared with baseline were found, whereas significant changes in the placebo group were not observed. Within-group differences were statistically significant in favor of the experimental group for glucose peak at OGTT, serum insulin, insulin resistance markers, and flow-mediated dilation. Changes in lipid and anthropometric parameters were not observed, although there was a trend for lower cholesterol levels and a decrease in body weight in the experimental group. Decreases in systolic blood pressure were also higher among subjects in the experimental group. This exploratory study confirms the antidiabetic activity of Sclerocarya birrea in prediabetes. Further studies using better measurements of beta-cell function are needed to clarify the underlying mechanisms of the hypoglycemic effect of this natural compound.

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113 Dasotraline for the Treatment of Moderate to Severe Binge Eating Disorder in Adults: Results From a Randomized, Double-Blind, Placebo-Controlled Study

CNS Spectrums ◽

10.1017/s1092852918000135 ◽

2018 ◽

Vol 23 (1) ◽

pp. 72-73 ◽

Cited By ~ 3

Author(s):

Bradford Navia ◽

James I. Hudson ◽

Susan L McElroy ◽

Anna I. Guerdjikova ◽

Ling Deng ◽

...

Keyword(s):

Placebo Group ◽

Eating Disorder ◽

Binge Eating ◽

Binge Eating Disorder ◽

Repeated Measures ◽

Plasma Concentrations ◽

Controlled Study ◽

Obsessive Compulsive ◽

Double Blind ◽

Secondary Endpoints

AbstractObjectivesBinge eating disorder (BED) is the most common eating disorder in the US, with a lifetime prevalence of 2.8%. Disturbances in reward circuitry have been implicated in its pathogenesis. Dasotraline is a novel and potent dopamine and norepinephrine reuptake inhibitor with slow absorption and a long half-life resulting in stable plasma concentrations over 24 hours with once-daily dosing. This study evaluated the efficacy and safety of flexibly-dosed dasotraline (4, 6, and 8 mg/day) vs placebo in adults with moderate to severe BED over a 12-week period (NCT02564588).MethodsKey inclusion criteria included moderate to severe BED based on a history of ≥2 binge eating days/week for ≥6 months prior to screening, and ≥3 binge eating days for each of2 weeks prior to randomization, as documented in participant’s binge eating diary. Patients were randomized 1:1 to flexibly-dosed dasotraline (4, 6, 8 mg/day) or placebo. Theprimary endpoint was change from baseline (CFB) in the number of binge eating days per week at Week 12. Key secondary endpoints were: CFB in Clinical Global Impression–Severity (CGI-S) Scale at Week 12; CFB in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) at Week 12; and the percentage ofsubjects with a 4-week cessation from binge eating prior to Week 12 or end of treatment (EOT). Except for 4-week cessation, the other three variables were analyzed using amixed model for repeated measures (MMRM).Results317 subjects (84% female) received ≥1 dose of study medication (mean age was 38.2 years; mean number of binge eating days per week, 4.25; mean CGI-S score, 4.5; mean BMI, 34.7). The MMRM analysis of CFB at Week 12 in the number of binge days/week yielded a significant mean difference of –0.99 (95% CI: –0.65 to –1.33; p<0.001) infavour of dasotraline (–3.74 in the dasotraline group vs –2.75 in the placebo group). All three key secondary endpoints were met at Week 12 or EOT: 46.5% of subjects in thedasotraline group achieved at least 4 consecutive weeks’ cessation from binge eating vs 20.6% in the placebo group (p<0.001); CFB in CGI-S and YBOCS-BE scores were also statistically significant in favour of dasotraline (p<0.001). The treatment-emergent adverse events (TEAEs) that occurred more frequently with dasotraline vs placebo at >2% incidence included: insomnia (44.6% vs 8.1%), dry mouth (27.4% vs 5.0%), decreased appetite (19.7% vs 6.9%), anxiety (17.8% vs 2.5%), nausea (12.7% vs 6.9%) and decreased body weight (12.1% vs 0%). Discontinuation due to AEs occurred in 11.5% of patients taking dasotraline vs 2.5% taking placebo.ConclusionsIn adults with moderate to severe BED, there were highly significant and clinically meaningful reductions with dasotraline vs placebo in the frequency of binge eating, global severity of illness, and obsessive-compulsive symptoms related to binge eating. These results suggest dasotraline may offer a novel, well-tolerated and efficacious treatmentfor BED.Funding AcknowledgementsStudy sponsored by Sunovion Pharmaceuticals Inc.

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Continuation of Growth Hormone (GH) Replacement in GH-Deficient Patients during Transition from Childhood to Adulthood: A Two-Year Placebo-Controlled Study

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/jcem.85.5.6598 ◽

2000 ◽

Vol 85 (5) ◽

pp. 1874-1881 ◽

Cited By ~ 44

Author(s):

Nina Vahl ◽

Anders Juul ◽

Jens O. L. Jørgensen ◽

Hans Ørskov ◽

Niels E. Skakkebæk ◽

...

Keyword(s):

Body Composition ◽

Controlled Trial ◽

Muscle Volume ◽

Thigh Muscle ◽

Controlled Study ◽

Gh Therapy ◽

Gh Treatment ◽

Double Blind ◽

Gh Replacement ◽

Igf I

Abstract Previous studies have demonstrated beneficial effects of GH replacement, in adults with GH deficiency (GHD), on body composition, physical fitness, and quality of life. These studies, however, concern patients with adult-onset GHD or childhood-onset (CO) patients enrolled several years after withdrawal of initial therapy. So far, the effects of continuation of GH-administration in patients with CO-GHD have not been examined. We studied a group of nineteen young adults (13 males+ 6 females; 16–26 yr old; mean age, 20.2 ± 0.65 yr) with CO-GHD, in a randomized, parallel, double-blind, placebo-controlled trial for 1 yr, followed by an open phase with GH for 1 yr. All patients received GH therapy at the start of study, and trial medication (GH/placebo) was given in a similar dose. Patients randomized to continued GH treatment exhibited no significant changes in any parameters tested, but intra- and interindividual variations in insulin-like growth factor (IGF)-I levels could suggest compliance problems. Discontinuation of GH for 1 yr resulted in a decrease in serum IGF-I, from 422.0 ± 56.8 to 147.8 ± 33.4 μg/L, in the placebo group (P = 0.003). After discontinuation of GH for 1 yr, an increase in total body fat (TBF, kg), measured by dual-energy x-ray absorptiometry scan, was seen[ placebo: 22.7 ± 2.7 to 26.5 ± 2.5 (P = 0.01); GH:16.2 ± 2.1 to 17.2 ± 2.1 (not significant)]. Resumption of GH after placebo was followed by increments in serum IGF-I (μg/L) [from 147.8 ± 33.4 to 452 ± 76 (P = 0.001)] and IGF-binding protein 3, as well as in fasting glucose (mmol/L) [4.9 ± 0.2 vs. 5.3 ± 0.2 (P = 0.03)]. After resumption of GH lean body mass (kg) increased [52.4 ± 4.9 vs. 60.7 ± 5.6 (P = 0.006)]. Likewise, resumption of GH therapy increased thigh muscle volume and thigh muscle/fat ratio, as assessed by computed tomography [muscle volume (cm2/10 mm): 118.2 ± 11.7 vs. 130.0 ± 10.9 (P = 0.002); muscle/fat ratio: 1.33 ± 0.24 vs. 1.69 ± 0.36 (P = 0.02)]. In conclusion, discontinuation of GH treatment in GHD patients, during the transition from childhood to adulthood, induces significant and potentially unfavorable changes in IGF-I and body composition, both of which are reversed after resumption of GH treatment. By contrast, continuation of GH therapy results in unaltered IGF-I and body composition. We recommend continuation of GH therapy in these patients, to be undertaken in collaboration between pediatricians and adult endocrinologists.

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Effects of Consumption of Probiotic Powder Containing Lactobacillus Plantarum Dad-13 on Fecal Bacterial Population in School-Age Children in Indonesia

International Journal of Probiotics and Prebiotics ◽

10.37290/ijpp2641-7197.14:1-8 ◽

2019 ◽

Vol 14 (1) ◽

pp. 1-8 ◽

Cited By ~ 1

Author(s):

Banin Maghfirotin Marta ◽

Utami Tyas ◽

Cahyanto Muhammad Nur ◽

Widada Jaka ◽

Rahayu Endang Sutriswati

Keyword(s):

Placebo Group ◽

Gut Microbiota ◽

Lactobacillus Plantarum ◽

Coliform Bacteria ◽

School Age Children ◽

Controlled Study ◽

School Age ◽

Double Blind ◽

Probiotic Group ◽

E Coli

Consumption of probiotics is known to influence the gut microbiota. The aim of this study was to assess the effect of probiotic powder containing Lactobacillus plantarum Dad-13 on bacterial composition in the gut by examining fecal samples of school-age children in Yogyakarta, Indonesia. This is a randomized, double-blind, placebo-controlled study. A total of 40 healthy subjects were recruited for this study and were divided into two groups: placebo group and probiotic group. The placebo group consumed skim milk and the probiotic group consumed probiotic powder containing L. plantarum Dad-13 (2 × 109 CFU/g) for 65 days. The results showed that placebo intake had no significant effect on gut microbiota; however, probiotic caused a significant increase in L. plantarum and Lactobacillus population, while decreasing the population of E. coli and non-E. coli coliform bacteria by 55% and 75%, respectively and Bifidobacteria count did not change significantly. The study concluded that consumption of probiotic powder L. plantarum Dad-13 could increase propionic acid thereby decreasing the gut pH which has an effect on the microbial population.

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Cerebellar rTMS in PSP: a Double-Blind Sham-Controlled Study Using Mobile Health Technology

The Cerebellum ◽

10.1007/s12311-021-01239-6 ◽

2021 ◽

Author(s):

Andrea Pilotto ◽

Maria Cristina Rizzetti ◽

Alberto Lombardi ◽

Clint Hansen ◽

Michele Biggi ◽

...

Keyword(s):

Digital Technology ◽

Repetitive Transcranial Magnetic Stimulation ◽

Health Technology ◽

Controlled Study ◽

Double Blind ◽

Non Invasive ◽

Lower Back ◽

Before And After ◽

Double Blind Design ◽

Theta Burst

AbstractThere are no effective treatments in progressive supranuclear palsy (PSP). The aim of this study was to test the efficacy of theta burst repetitive transcranial magnetic stimulation (rTMS) on postural instability in PSP. Twenty PSP patients underwent a session of sham or real cerebellar rTMS in a crossover design. Before and after stimulation, static balance was evaluated with instrumented (lower back accelerometer, Rehagait®, Hasomed, Germany) 30-s trials in semitandem and tandem positions. In tandem and semitandem tasks, active stimulation was associated with increase in time without falls (both p=0.04). In the same tasks, device-extracted parameters revealed significant improvement in area (p=0.007), velocity (p=0.005), acceleration and jerkiness of sway (p=0.008) in real versus sham stimulation. Cerebellar rTMS showed a significant effect on stability in PSP patients, when assessed with mobile digital technology, in a double-blind design. These results should motivate larger and longer trials using non-invasive brain stimulation for PSP patients.

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DL-3-n-butylphthalide improves cerebral hypoperfusion in patients with large cerebral atherosclerotic stenosis. A single-center, randomized, double-blind, placebo-controlled study.

10.21203/rs.2.23503/v2 ◽

2020 ◽

Author(s):

Dawei Chen ◽

Yanwei Yin ◽

Jin Shi ◽

Fen Yang ◽

Kehua Wang ◽

...

Keyword(s):

Placebo Group ◽

Single Photon ◽

Photon Emission ◽

Cerebral Hypoperfusion ◽

Controlled Study ◽

Emission Computed Tomography ◽

Single Center ◽

Double Blind ◽

Double Blind Placebo ◽

Atherosclerotic Stenosis

Abstract Background: DL-3-n-butylphthalide (NBP) was demonstrated to increase the cerebral blood flow (CBF) in the animal models, but there are no clinic studies to verify this. We aimed to explore the effect of NBP on improving cerebral hypoperfusion caused by cerebral large-vessel stenosis. Methods: In this single-center, randomized, double-blind, placebo-controlled study, 120 patients with severe carotid atherosclerotic stenosis and cerebral hypoperfusion in the ipsilateral middle cerebral artery (MCA) were included and randomly assigned into NBP or placebo group as 1:1 radio. Patients in NBP or placebo group received 200mg or 20mg of NBP capsules three times daily for four weeks respectively. Single photon emission computed tomography (SPECT) was used to assess regional CBF (rCBF) in four regions of interest (ROIs) corresponding to MCA before and 12 weeks after the treatment. After therapy, the rCBF change for every ROI and the whole CBF change in MCA territory for every patient were classified into amelioration, stabilization and deterioration respectively. Results: 48 NBP patients (6 with bilateral stenosis) and 46 placebo patients (8 with bilateral stenosis) completed the trial. Overall, both groups had 54 stenotic carotid arteries and 216 ROIs for rCBF change analysis. After therapy, the rCBF in ROIs increased in NBP group (83.5%±11.4% vs. 85.8%±12.5%, p=0.000), whereas no change was found in placebo group (86.9%±11.6% vs. 87.8%±11.7%, p=0.331). Besides, there was higher percentages of ROIs with rCBF amelioration and stabilization in NBP group than in placebo group (93.1% vs. 79.2%, p=0.000). Furthermore, ordinal regression analysis showed that compared with placebo, NBP independently made more patients to have whole CBF amelioration in ipsilateral MCA (Wald-χ2=5.247, OR=3.31, p=0.022). Conclusions: NBP might improve the cerebral hypoperfusion in the patients with carotid artery atherosclerotic stenosis. Trial registration: Chinese Clinical Trial Registry, ChiCTR1900028005, registered December 8th 2019- Retrospectively registered ( http://www.chictr.org.cn/index.aspx ).

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Effects of luteolin-rich chrysanthemum flower extract on purine base absorption and blood uric acid in Japanese subjects

Functional Foods in Health and Disease ◽

10.31989/ffhd.v12i1.863 ◽

2022 ◽

Vol 12 (1) ◽

pp. 12

Author(s):

Tsuyoshi Takara ◽

Kazuo Yamamoto ◽

Naoko Suzuki ◽

Shin-ichiro Yamashita ◽

Shin-ichiro Iio ◽

...

Keyword(s):

Uric Acid ◽

Placebo Group ◽

Serum Uric Acid ◽

Random Number Generator ◽

Double Blind ◽

Japanese Men ◽

Purine Base ◽

Flower Extract ◽

Before And After ◽

Body Parameters

Background and objective: Chrysanthemum flowers are consumed as fresh condiments, herbal teas, and processed foods in Japan and Taiwan. They contain luteolin as a major polyphenol and are traditionally used for eye care. We previously demonstrated that the ingestion of Chrysanthemum flower extract (CFE) for 1 month reduced serum uric acid levels. However, the findings obtained were considered to be biased because the study was performed by a CFE manufacturer. Therefore, we herein conducted a clinical trial on CFE on a larger scale and examined its effects on purine base absorption from the intestines, which represents an effective approach for reducing serum uric acid levels. Methods: Both studies were performed as randomized, double-blind, placebo-controlled trials and CFE (100 mg) containing 1 mg of luteolin was used as the active sample. We enrolled 44 healthy Japanese men and women with 6.0 to 7.9 mg/dL serum uric acid. All subjects were randomly allocated to an active group (n=22) or placebo group (n=22) using a computerized random number generator. In the purine base absorption study, CFE was ingested with a purine base-rich diet and serum uric acid levels were measured chronologically. In the 12-week consecutive ingestion study, CFE or placebo was administered between January and April 2021. Serum uric acid levels after 12 weeks were assessed as the primary outcome, and uric acid were measured before and after 4 weeks of the intervention as secondary outcomes. Blood, urine and body parameters were examined to evaluate the safety of CFE. Results: Thirty-nine subjects completed the trial, and the per protocol set comprised 18 and 21 subjects in the active and placebo groups, respectively. In the single dosing study of CFE on subjects loaded by the purine base-rich diet, no significant changes were observed between the CFE and placebo groups. On the other hand, in the 12-week ingestion study, serum uric acid levels were significantly lower in the CFE group than in the placebo group. Laboratory tests revealed no abnormalities to suggest any side effects of CFE.Conclusions: CFE (100 mg/day) containing 1 mg of luteolin reduced serum uric acid levels. CFE may be beneficial for improving hyperurichemia. Trial Registration: UMIN-CTR: UMIN000042327Foundation: The present study was funded by Oryza Oil & Fat Chemical Co., Ltd. Keywords: Chrysanthemum, luteolin, uric acid, purine base

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A Randomised Controlled Trial on the Efficacy and Safety of Oral Ketamine in Neonatal Circumcision

JOURNAL FOR CLINICAL AND DIAGNOSTIC RESEARCH ◽

10.7860/jcdr/2021/46341.14400 ◽

2021 ◽

Author(s):

Victor Ifeanyichukwu Modekwe ◽

Jideofor Okechukwu Ugwu ◽

Okechukwu Hyginus Ekwunife ◽

Andrew Nwankwo Osuigwe ◽

Jideofor Chukwuma Orakwe ◽

...

Keyword(s):

Placebo Group ◽

Controlled Trial ◽

Controlled Study ◽

Categorical Variables ◽

Paediatric Surgery ◽

Peripheral Oxygen Saturation ◽

Double Blind ◽

Oral Ketamine ◽

The Mean ◽

Neonatal Circumcision

Introduction: Procedural analgesia use in neonatal circumcision is not widespread in the developing world. An easy-to-administer, adequate and safe analgesia will encourage usage in neonatal circumcision. Orally administered ketamine may prove effective and safe, and may encourage procedural analgesia use in neonatal circumcision. Aim: To determine the analgesic efficacy of oral ketamine in Plastibell® neonatal circumcision. Materials and Methods: A hospital based randomised double blind controlled study was conducted at the paediatric surgery unit of the hospital, from March 2015 to December 2015. Total 121 neonates were sequentially recruited, and randomised into two groups. Group A received oral ketamine, and Group B received plain syrup (placebo) as procedural analgesia. Continuous pulse oximeter monitoring was done before, during and immediately after the procedure. The pre-procedural and intra-procedural peripheral oxygen saturation (SpO2) and Pulse Rate (PR) were determined at the various stages. Also, the Neonatal Infant Pain Scale (NIPS) scores were assessed during the stages of the procedure. Differences in mean scores were analysed. Mann-Whitney U test and Independent t-test were used to compare means of continuous variable, while Fisher’s exact test was used to compare categorical variables. Significance was set at p<0.05. Results: Sixty-one neonates received oral ketamine, while 60 received placebo. The intraoperative mean SpO2 were lower in the placebo group and significant at the tying stage with p=0.022. The mean intraoperative PR was higher in the placebo group and significant at dorsal-slit, tying and excision stages (p<0.05). The mean intraoperative NIPS scores were significantly higher in the placebo group. Conclusion: Oral ketamine provides effective and safe analgesia for neonatal Plastibell® circumcision in comparison to placebo.

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