Does intraoperative ciprofloxacin‐soaked gelfoam have adverse effects on graft success rate? A randomized, double‐blind controlled trial

Objective. To evaluate the effects of aminophylline (Am) in children hospitalized with asthma. Methods. Prospective, randomized, double-blind, placebo-controlled trial. Subjects were children between the ages of 5 and 18 years admitted for asthma exacerbation to either a tertiary care children's hospital or an innercity general hospital in New York. Exclusion criteria were admission to the intensive care unit, initial theophylline level > 5 µg/dL, or the presence of other systemic disorders. All patients received nebulized albuterol therapy and intravenous glucocorticosteroids in standardized doses. Thirty-one patients were randomized to receive either an Am bolus followed by continuous Am infusion or placebo (P) bolus and infusion. The outcome variables were: duration of hospitalization, percent of predicted peak expiratory flow rates recorded at 12-hour intervals, number of albuterol treatments required, and adverse effects. Results. There were no significant differences at study entry in age, sex, race, number of previous hospital admissions, prior medications used, clinical symptom scores, or initial peak flow rates for the two groups. For 26 patients who completed this study, 15 patients in the P group were hospitalized for a mean duration of 2.33 ± 1.3 days, whereas 11 patients in the Am group required 2.58 ± 1.5 days. There were no significant differences between the two groups for hospital days, peak flow rates at any time interval, or amount of albuterol therapy required (P > .2). In the Am group, 6 of the 14 patients who entered the study experienced significant adverse effects consisting of nausea, emesis, headache, abdominal pain, and palpitations. Only 1 of 17 patients in the P group had an adverse effect (P <. 05). Conclusions. There is no benefit and considerable risk of adverse effects associated with the use of Am in hospitalized asthmatic children.

The Effect of Oral Niacinamide on Plasma Phosphorus Levels in Peritoneal Dialysis Patients

Peritoneal Dialysis International ◽

10.1177/089686080902900515 ◽

2009 ◽

Vol 29 (5) ◽

pp. 562-567 ◽

Cited By ~ 29

Author(s):

Daniel O. Young ◽

Steven C. Cheng ◽

James A. Delmez ◽

Daniel W. Coyne

Keyword(s):

Peritoneal Dialysis ◽

Adverse Effects ◽

Controlled Trial ◽

Treatment Options ◽

Study Drug ◽

Phosphate Binders ◽

Open Label ◽

Double Blind ◽

Phosphorus Levels ◽

Plasma Phosphorus

Background Hyperphosphatemia remains a significant problem for patients requiring dialysis and is associated with increased mortality. Current treatment options include dietary restriction, dialysis, and phosphate binders. Treatment using the latter is frequently limited by cost, tolerability, and calcium loading. One open-label trial found niacinamide to be effective at decreasing serum phosphorus values in hemodialysis patients. Niacinamide may effectively reduce phosphorus levels in peritoneal dialysis (PD) patients already receiving standard phosphorus-lowering therapies. Methods An 8 week, randomized, double blind, placebo-controlled trial to evaluate the effectiveness of niacinamide to reduce plasma phosphorus levels in PD patients. Patients had to demonstrate a baseline phosphorus value > 4.9 mg/dL. Patients were randomized to niacinamide or placebo and prescribed 250 mg twice daily, with titration to 750 mg twice daily, as long as safety parameters were not violated. Phosphate binders, active vitamin D, and cinacalcet were kept constant during the study. The primary end point was change in plasma phosphorus. Secondary end points included changes in lipid parameters. Results 15 patients started on the study drug (8 niacinamide, 7 placebo) and 7 in each arm had at least one on-study phosphorus measurement. The niacinamide treatment group experienced an average 0.7 ± 0.9 mg/dL decrease in plasma phosphorus and the placebo-treated group experienced an average 0.4 ± 0.8 mg/dL increase. The treatment effect difference (1.1 mg/dL) was significant ( p = 0.037). No significant changes in high- or low-density lipoproteins or triglycerides were demonstrated. Two of the 8 patients randomized to the niacinamide treatment arm had to withdraw from the study due to drug-related adverse effects. Adverse effects may limit the use of niacinamide in PD patients. Conclusion Niacinamide, when added to standard phosphorus-lowering therapies, resulted in a modest yet statistically significant reduction in plasma phosphorus levels at 8 weeks. [ClinicalTrials.gov number NCT00508885 (ClinicalTrials.gov)]

Cinnarizine and sodium valproate as the preventive agents of pediatric migraine: A randomized double-blind placebo-controlled trial

Cephalalgia ◽

10.1177/0333102419888485 ◽

2019 ◽

Vol 40 (7) ◽

pp. 665-674

Author(s):

Man Amanat ◽

Mansoureh Togha ◽

Elmira Agah ◽

Mahtab Ramezani ◽

Ali Reza Tavasoli ◽

...

Keyword(s):

Placebo Group ◽

Adverse Effects ◽

Confidence Interval ◽

Children And Adolescents ◽

Sodium Valproate ◽

Medical Center ◽

Controlled Trial ◽

Migraine Prophylaxis ◽

Double Blind ◽

Double Blind Placebo

Background Few migraine preventive agents have been assessed in a pediatric population. We evaluated the safety and efficacy of cinnarizine and sodium valproate for migraine prophylaxis in children and adolescents. Methods We carried out a randomized double-blind placebo-controlled trial in the Children’s Medical Center and Sina hospital, Tehran, Iran. Eligible participants were randomly assigned in 1:1:1 ratio via interactive web response system to receive either cinnarizine, sodium valproate, or placebo. The primary endpoints were the mean change in frequency and intensity of migraine attacks from baseline to the last 4 weeks of trial. The secondary endpoint was the efficacy of each drug in the prevention of migraine. The drug was considered effective if it decreased migraine frequency by more than 50% in the double-blind phase compared with the baseline. Safety endpoint was adverse effects that were reported by children or their parents. Results A total of 158 children participated. The frequency of migraine attacks significantly reduced compared to baseline in cinnarizine (difference: −8.0; 95% confidence interval (CI): −9.3 to −6.6), sodium valproate (difference: −8.3; 95% confidence interval: −9.3 to −7.2), and placebo (difference: −4.4; 95% confidence interval: −5.4 to −3.4) arms. The decrease was statistically greater in cinnarizine (difference: −3.6; 95% confidence interval: −5.5 to −1.6) and sodium valproate (difference: −3.9; 95% confidence interval: −5.8 to −1.9) arms, compared to placebo group. Children in all groups had significant reduction in intensity of episodes compared to baseline (cinnarizine: −4.6; 95% confidence interval: −5.2 to −4.0; sodium valproate: −4.0; 95% confidence interval: −4.8 to −3.3; placebo: −2.6; 95% confidence interval: −3.4 to −1.8). The decrease was statistically greater in cinnarizine (difference: −2.0; 95% confidence interval: −3.2 to −0.8) and sodium valproate (difference: −1.5; 95% confidence interval: −2.7 to −0.3) arms, compared to the placebo group. Seventy-one percent of individuals in the cinnarizine group, 66% of cases in the sodium valproate group, and 42% of people in the placebo arm reported more than 50% reduction in episodes at the end of the trial. The odds ratio for >50% responder rate was 3.5 (98.3% confidence interval: 1.3 to 9.3) for cinnarizine versus placebo and 2.7 (98.3% confidence interval: 1.0 to 6.9) for sodium valproate versus placebo. Nine individuals reported adverse effects (three in cinnarizine, five in sodium valproate, and one in the placebo group) and one case in the sodium valproate group discontinued the therapy due to severe sedation. Conclusion Cinnarizine and sodium valproate could be useful in migraine prophylaxis in children and adolescents. Trial registration: IRCT201206306907N4.

The Effects of Clinical Hypnosis versus Neurolinguistic Programming (NLP) before External Cephalic Version (ECV): A Prospective Off-Centre Randomised, Double-Blind, Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2012/626740 ◽

2012 ◽

Vol 2012 ◽

pp. 1-6 ◽

Cited By ~ 3

Author(s):

Joscha Reinhard ◽

Swati Peiffer ◽

Nicole Sänger ◽

Eva Herrmann ◽

Juping Yuan ◽

...

Keyword(s):

Medical Care ◽

Success Rate ◽

Controlled Trial ◽

Randomised Trial ◽

External Cephalic Version ◽

Control Group ◽

Amniotic Fluid Index ◽

Double Blind ◽

Standard Medical Care ◽

Clinical Hypnosis

Objective. To examine the effects of clinical hypnosis versus NLP intervention on the success rate of ECV procedures in comparison to a control group.Methods. A prospective off-centre randomised trial of a clinical hypnosis intervention against NLP of women with a singleton breech fetus at or after 370/7(259 days) weeks of gestation and normal amniotic fluid index. All 80 participants heard a 20-minute recorded intervention via head phones. Main outcome assessed was success rate of ECV. The intervention groups were compared with a control group with standard medical care alone ().Results. A total of 42 women, who received a hypnosis intervention prior to ECV, had a 40.5% (), successful ECV, whereas 38 women, who received NLP, had a 44.7% () successful ECV (). The control group had similar patient characteristics compared to the intervention groups (). In the control group () 27.3% () had a statistically significant lower successful ECV procedure than NLP () and hypnosis and NLP ().Conclusions. These findings suggest that prior clinical hypnosis and NLP have similar success rates of ECV procedures and are both superior to standard medical care alone.

Hydrocortisone as an Intervention for Dexamethasone-Induced Adverse Effects in Pediatric Patients With Acute Lymphoblastic Leukemia: Results of a Double-Blind, Randomized Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.2015.66.0761 ◽

2016 ◽

Vol 34 (19) ◽

pp. 2287-2293 ◽

Cited By ~ 22

Author(s):

Lidewij T. Warris ◽

Marry M. van den Heuvel-Eibrink ◽

Femke K. Aarsen ◽

Saskia M.F. Pluijm ◽

Marc B. Bierings ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Acute Lymphoblastic Leukemia ◽

Adverse Effects ◽

Pediatric Patients ◽

Lymphoblastic Leukemia ◽

Controlled Trial ◽

Metabolic Parameters ◽

Dexamethasone Treatment ◽

Double Blind ◽

Randomized Controlled

Purpose Dexamethasone is a key component in the treatment of pediatric acute lymphoblastic leukemia (ALL), but can induce serious adverse effects. Recent studies have led to the hypothesis that neuropsychological adverse effects may be a result of cortisol depletion of the cerebral mineralocorticoid receptors. We examined whether including a physiologic dose of hydrocortisone in dexamethasone treatment can reduce neuropsychologic and metabolic adverse effects in children with ALL. Patients and Methods We performed a multicenter, double-blind, randomized controlled trial with a crossover design. Of 116 potentially eligible patients (age 3 to 16 years), 50 were enrolled and were treated with two consecutive courses of dexamethasone in accordance with Dutch Childhood Oncology Group ALL protocols. Patients were randomly assigned to receive either hydrocortisone or placebo in a circadian rhythm (10 mg/m2/d) during both dexamethasone courses. Primary outcome measure was parent-reported Strength and Difficulties Questionnaire in Dutch, which assesses psychosocial problems. Other end points included questionnaires, neuropsychological tests, and metabolic parameters. Results Of 48 patients who completed both courses, hydrocortisone had no significant effect on outcome; however, a more detailed analysis revealed that in 16 patients who developed clinically relevant psychosocial adverse effects, addition of hydrocortisone substantially reduced their Strength and Difficulties Questionnaire in Dutch scores in the following domains: total difficulties, emotional symptoms, conduct problems, and impact of difficulties. Moreover, in nine patients who developed clinically relevant, sleep-related difficulties, addition of hydrocortisone reduced total sleeping problems and disorders of initiating and maintaining sleep. In contrast, hydrocortisone had no effect on metabolic parameters. Conclusion Our results suggest that adding a physiologic dose of hydrocortisone to dexamethasone treatment can reduce the occurrence of serious neuropsychological adverse effects and sleep-related difficulties in pediatric patients with ALL.

Safe and effective delivery of supplemental iron to healthy older adults: The double-blind, randomized, placebo-controlled trial protocol of the Safe Iron Study

Gates Open Research ◽

10.12688/gatesopenres.13039.1 ◽

2019 ◽

Vol 3 ◽

pp. 1510

Author(s):

Erin D. Lewis ◽

Dayong Wu ◽

Joel B. Mason ◽

Athar H. Chishti ◽

John M. Leong ◽

...

Keyword(s):

Iron Deficiency ◽

Adverse Effects ◽

Phase I ◽

Ex Vivo ◽

Iron Status ◽

Controlled Trial ◽

Double Blind ◽

Sulfate Heptahydrate ◽

Bacterial Proliferation ◽

Forms Of Iron

The forms of iron currently available to correct iron deficiency have adverse effects, including infectious diarrhea, increased susceptibility to malaria, inflammation and detrimental changes to the gut microbiome. These adverse effects limit their use such that the growing burden of iron deficiency has not abated in recent decades. Here, we summarize the protocol of the “Safe Iron Study”, the first clinical study examining the safety and efficacy of novel forms of iron in healthy, iron-replete adults. The Safe Iron Study is a double-blind, randomized, placebo-controlled trial conducted in Boston, MA, USA. This study compares ferrous sulfate heptahydrate (FeSO4·H2O) with two novel forms of iron supplements (iron hydroxide adipate tartrate (IHAT) and organic fungal iron metabolite (Aspiron™ Natural Koji Iron)). In Phase I, we will compare each source of iron administrated at a low dose (60 mg Fe/day). We will also determine the effect of FeSO4 co-administrated with a multiple micronutrient powder and weekly administration of FeSO4. The forms of iron found to produce no adverse effects or adverse effects no greater than FeSO4 in Phase I, Phase II will evaluate a higher, i.e., a therapeutic dose (120 mg Fe/day). The primary outcomes of this study include ex vivo malaria (Plasmodium falciparum) infectivity of host erythrocytes, ex vivo bacterial proliferation (of selected species) in presence of host plasma and intestinal inflammation assessed by fecal calprotectin. This study will test the hypotheses that the novel forms of iron, administered at equivalent doses to FeSO4, will produce similar increases in iron status in iron-replete subjects, yet lower increases in ex vivo malaria infectivity, ex vivo bacterial proliferation, gut inflammation. Ultimately, this study seeks to contribute to development of safe and effective forms of supplemental iron to address the global burden of iron deficiency and anemia. Registration: ClinicalTrials.gov identifier: NCT03212677; registered: 11 July 2017.

Lorazepam as an adjuvant to haloperidol for agitated delirium at the end of life: A double-blind randomized controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.10003 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 10003-10003

Author(s):

David Hui ◽

Susan Frisbee-Hume ◽

Annie Wilson ◽

Seyedeh Dibaj ◽

Thuc Nguyen ◽

...

Keyword(s):

Overall Survival ◽

Adverse Effects ◽

Controlled Trial ◽

Group Differences ◽

Double Blind ◽

Wilcoxon Rank Sum Test ◽

Comparison Results ◽

Secondary Endpoints ◽

Agitated Delirium ◽

Clinical Trial Information

10003 Background: Agitated delirium is a highly distressing neuropsychiatric syndrome common in the last days of life. The use of benzodiazepines for agitated delirium is highly controversial. We compared the effect of lorazepam versus placebo as an adjuvant to haloperidol for persistent agitated delirium. Methods: In this double-blind trial, we randomly assigned patients with advanced cancer admitted to an acute palliative care unit with agitated delirium despite scheduled haloperidol to either lorazepam 3 mg IV or placebo, in addition to haloperidol 2 mg IV upon the onset of agitation. The primary outcome was the Richmond Agitation Sedation Scale (RASS) over the first 8 hours, ranging from -5 (unarousable) to +4 (combative). Secondary endpoints were rescue neuroleptic use, perceived comfort, delirium-related distress, adverse effects and overall survival. 26 patients per arm provided 80% power to detect a between arm difference of 0.5 effect size in mean RASS with a=5%. We used the Wilcoxon Rank Sum test for primary comparison. Results: 52 of 58 (90%) patients who received the medications completed 8 h of observation. RASS decreased significantly within 30 min of treatment in both arms (Table). The lorazepam arm was associated with significantly greater reduction of RASS (Table), less rescue neuroleptics (mean haloperidol equivalent dose 1 mg v. 3 mg, P=0.02), and greater comfort as perceived by blinded caregivers (84% v. 37%, P=0.007) and nurses (77% v. 30%, P=0.005) compared to placebo. We found no significant between-group differences in delirium-related distress, adverse effects and overall survival (median 68 v. 73 h, P=0.56). Conclusions: The combination of lorazepam/haloperidol resulted in rapid and significant reduction of agitation compared to haloperidol alone. Our study supports the judicious use of single dose lorazepam/haloperidol for persistent agitated delirium. Clinical trial information: NCT01670097. [Table: see text]

SP1.2.9To Evaluate the Analgesic Efficacy of Intraperitoneal Tramadol Vs Placebo for Post Operative Pain Relief Following Laparoscopic Cholecystectomy, A Double Blind Randomized Control Trial

British Journal of Surgery ◽

10.1093/bjs/znab361.019 ◽

2021 ◽

Vol 108 (Supplement_7) ◽

Author(s):

Siddhartha Handa ◽

MS Sangolli ◽

Sanjay Panchal

Keyword(s):

Adverse Effect ◽

Laparoscopic Cholecystectomy ◽

Pain Relief ◽

Adverse Effects ◽

Controlled Trial ◽

Analgesic Efficacy ◽

Double Blind ◽

Institutional Ethics ◽

Intraperitoneal Instillation ◽

The Mean

Abstract Aim To study the effectiveness of intraperitoneal instillation of tramadol for postoperative laparoscopic cholecystectomy (LC) pain relief and improve incidence of adverse effect. Methods Double blinded randomized controlled trial over 1 year. The Ethical Clearance was obtained from Institutional Ethics Committee. 60 patients scheduled for LC were enrolled in the study. Patients were randomly assigned into 2 groups using computer generated random numbers. Group T: Received intraperitoneal tramadol 100 mg (diluted in 20 mls distilled water). Group S: Received 20 ml of intraperitoneal normal saline. Pain was assessed using VAS. The assessment was done at 0, 15, 30, 60 minutes, 4, 8, 12, 16 and 24 hours. Incidence of adverse effect were observed. Results In group T, the mean pain scores at all the intervals were significantly low (p < 0.050) except at 24 hours (p = 0.210). Analgesia requirement was significantly high in group S compared to group T immediate post op, 15, 60 minutes, 8 and 12 hours (p < 0.050). The mean requirement of analgesia immediate post op, 15 minutes, 4 and 8 hours was significantly low in group T compared to group S (p < 0.050). 30% patients in group T did not require analgesia at all compared to S (p < 0.001). Incidence of adverse effects at 4 hours was 43% in group S compared to 40% in group T (p > 0.050). Conclusion Intraperitoneal instillation of tramadol in LC has beneficial effect in terms of postoperative pain relief following LC and lower requirement of analgesia. However, the incidence of adverse effects was comparable in both the groups.

The Safety of Mother’s Milk® Tea: Results of a Randomized Double-Blind, Controlled Study in Fully Breastfeeding Mothers and Their Infants

Journal of Human Lactation ◽

10.1177/0890334418787474 ◽

2018 ◽

Vol 35 (2) ◽

pp. 248-260 ◽

Cited By ~ 4

Author(s):

Carol L. Wagner ◽

Andrea D. Boan ◽

Alicia Marzolf ◽

Carolyn W. Finch ◽

Kristen Morella ◽

...

Keyword(s):

Quality Of Life ◽

Adverse Effects ◽

Controlled Trial ◽

Test Group ◽

Psychological State ◽

Controlled Study ◽

Double Blind ◽

Mother's Milk ◽

Mother’S Milk

Background: Various natural products are reported to improve maternal milk supply yet are not necessarily safe for infants. Researchers have not systematically studied galactagogue teas for safety. Research aim: This study evaluates the safety of a galactagogue tea in breastfeeding women and their infants, assessing short- and long-term adverse effects. Methods: Healthy, exclusively/fully breastfeeding women ( N = 60) with no milk insufficiency were randomized into (1) an all-natural tea containing fruits of bitter fennel, anise, and coriander; fenugreek seed; and other herbs (Mother’s Milk® herbal tea; test) group or (2) a lemon verbena leaf (placebo) group. Maternal diaries captured self-reported maternal and infant adverse effects, tea consumed, and perceived infant satisfaction. Maternal quality of life and psychological state were assessed at baseline and 2 and 4 weeks. Poststudy calls assessed adverse effects through the infants’ age of 12 months. Results: No adverse effects attributable to the interventions were reported at any time point. No differences were found between test and placebo groups in sociodemographic characteristics, maternal or infant adverse symptoms, quality of life, breastfeeding self-efficacy, maternal psychological measures, infant growth, and infant satisfaction (all p >.05). Conclusions: This double-blind, randomized controlled trial (RCT) of an herbal galactagogue versus placebo among healthy, exclusively/fully breastfeeding mothers and infants found no adverse events associated with the test tea across the 30-day study or the first year of their infant’s life. This composite tea appears to present no safety risk for mothers or their young babies.