Two oral sedation regimens in pediatric dentistry: a randomized controlled trial

Objectives: Dental procedures are always associated with some degree of anxiety, and children are usually more prone to it. General anesthesia may have to be used in more complex procedures, but many dental procedures can successfully be undertaken with therapeutic sedation. The aim of this trial was to evaluate the effectiveness of oral sedation using dexmedetomidine in comparison with ketamine in the management of uncooperative pediatric patients during dental treatment. Methodology: A randomized clinical trial was carried out on 40 ASA physical status-I children aged 2-6 y to investigate the effect of using dexmedetomidine and ketamine with atropine for sedation. The children were equally and randomly divided into two groups: Group K: received oral ketamine 5 mg/kg with atropine 0.01 mg/kg, and Group D: received oral dexmedetomidine 3 µg/kg. Recovery time, vital signs, and side effects were all recorded. Behavior rating was also assessed using the Ohio State University Behavioral Rating Scale (OSUBRS). Results: The children in Group D were more sedated than in Group K, but the difference was not statistically significant (p = 0.22). The median recovery time was significantly shorter in Group D than in Group K (p = 0.003). No adverse effects, episodes of respiratory or cardiovascular instability were noted in either groups. Conclusions: Oral dexmedetomidine is equally effective to oral ketamine for sedation in children undergoing outpatient dental procedures, but has relatively a shorter recovery time. Citation: Hammadyeh A, Altinawi M, Rostom F. Two oral sedation regimens in pediatric dentistry: a randomized controlled trial. Anaesth pain & intensive care 2019;23(4)__

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Objective recovery time with end-to-side versus side-to-side anastomosis after laparoscopic right hemicolectomy for colon cancer: a randomized controlled trial

Surgical Endoscopy ◽

10.1007/s00464-021-08536-5 ◽

2021 ◽

Author(s):

Min Hyun Kim ◽

Sung Il Kang ◽

Jung Rae Cho ◽

Jeehye Lee ◽

In Jun Yang ◽

...

Keyword(s):

Colon Cancer ◽

Randomized Controlled Trial ◽

Recovery Time ◽

Controlled Trial ◽

Right Hemicolectomy ◽

Randomized Controlled ◽

Laparoscopic Right Hemicolectomy

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Boxing vs Sensory Exercise for Parkinson’s Disease: A Double-Blinded Randomized Controlled Trial

Neurorehabilitation and Neural Repair ◽

10.1177/15459683211023197 ◽

2021 ◽

pp. 154596832110231

Author(s):

Kishoree Sangarapillai ◽

Benjamin M. Norman ◽

Quincy J. Almeida

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Randomized Controlled Trial ◽

Repeated Measures ◽

Rating Scale ◽

Controlled Trial ◽

Motor Symptoms ◽

Post Intervention ◽

Randomized Controlled ◽

Double Blinded

Background. Exercise is increasingly becoming recognized as an important adjunct to medications in the clinical management of Parkinson’s disease (PD). Boxing and sensory exercise have shown immediate benefits, but whether they continue beyond program completion is unknown. This study aimed to investigate the effects of boxing and sensory training on motor symptoms of PD, and whether these benefits remain upon completion of the intervention. Methods. In this 20-week double-blinded randomized controlled trial, 40 participants with idiopathic PD were randomized into 2 treatment groups, (n = 20) boxing or (n = 20) sensory exercise. Participants completed 10 weeks of intervention. Motor symptoms were assessed at (week 0, 10, and 20) using the Unified Parkinson’s Disease Rating Scale (UPDRS-III). Data were analyzed using SPSS, and repeated-measures ANOVA was conducted. Results. A significant interaction effect between groups and time were observed F(1, 39) = 4.566, P = .036, where the sensory group improved in comparison to the boxing group. Post hoc analysis revealed that in comparison to boxing, the effects of exercise did not wear off at washout (week 20) P < .006. Conclusion. Future rehabilitation research should incorporate similar measures to explore whether effects of exercise wear off post intervention.

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Evaluation of the short-term efficacy of local analgesic (lidocaine) and opioid analgesic (sufentanil) on patients with centrally mediated abdominal pain syndrome: a randomized controlled trial

Therapeutic Advances in Gastroenterology ◽

10.1177/17562848211021783 ◽

2021 ◽

Vol 14 ◽

pp. 175628482110217

Author(s):

Hang Yang ◽

Honglin Chen ◽

Bing Hu

Keyword(s):

Randomized Controlled Trial ◽

Abdominal Pain ◽

Rating Scales ◽

Rating Scale ◽

Controlled Trial ◽

Opioid Analgesic ◽

Pain Syndrome ◽

Short Term ◽

Randomized Controlled ◽

Term Efficacy

Background: Centrally mediated abdominal pain syndrome (CAPS) is characterized by continuous or frequently recurring abdominal pain and can result in functional loss across several life domains. The efficacy of the present management methods has not been established yet. We performed a prospective randomized controlled trial to explore the short-term efficacy of local analgesic (lidocaine) and opioid analgesic (sufentanil) in patients with CAPS. Methods: We consecutively enrolled 130 patients who met the Rome IV CAPS criteria and divided them into the sufentanil + lidocaine (S + L) group and sufentanil (S) group. Patients completed the pain rating scales, including the numeric rating scale (NRS) and verbal rating scale (VRS), 60 min before colonoscopy. All the patients were initially administered sufentanil. In the S + L group, we sprayed a 5 ml solution of lidocaine on the surface of ascending, transverse, descending, and sigmoid colon during colonoscope withdrawal, while 5 ml saline was sprayed in the S group. Follow up was performed 1 day, 3 days, 1 week, 2 weeks, 1 month, and 3 months after colonoscopy, to complete the pain scaling. Results: A comparison of the NRS and VRS showed that there were no significant differences between the S + L and S groups and within each group ( p > 0.05). Conclusions: Local analgesic lidocaine and opioid analgesic sufentanil showed negative efficacy during short-term observation. The opioid receptor blocker sufentanil did not worsen symptoms in patients with CAPS after colonoscopy under general anesthesia in the short term. [chictr.org.cn, Chinese Clinical Trial Identifier, ChiCTR-IOR-16008187]

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Intensive Motion Style Acupuncture Treatment (MSAT) Is Effective for Patients with Acute Whiplash Injury: A Randomized Controlled Trial

Journal of Clinical Medicine ◽

10.3390/jcm9072079 ◽

2020 ◽

Vol 9 (7) ◽

pp. 2079

Author(s):

Doori Kim ◽

Kyoung-Sun Park ◽

Jin-Ho Lee ◽

Won-Hyung Ryu ◽

Heeyoung Moon ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Whiplash Injury ◽

Rating Scale ◽

Acupuncture Treatment ◽

Controlled Trial ◽

Rank Test ◽

Control Group ◽

Korean Medicine ◽

Randomized Controlled ◽

Motion Style

In this single-center, parallel, randomized controlled trial, we aim to examine the effects and safety of motion style acupuncture treatment (MSAT; a combination of acupuncture and Doin therapy) on pain reduction and functional improvement in patients with whiplash-associated disorders (WADs). Ninety-seven patients with cervical pain admitted to the Bucheon Jaseng Hospital of Korean Medicine, South Korea, due to acute whiplash injury were treated with integrative Korean medicine (IKM) with (MSAT group, 48 patients) or without (control group, 49 patients) an additional 3-day MSAT during hospitalization (5–14 days) and followed-up for 90 days. The mean numeric rating scale (NRS) scores of the MSAT and control groups at baseline were 5.67 (95% confidence interval (CI), 5.33, 6.01) and 5.44 (95% CI, 5.06, 5.82), respectively, and on day 5, 3.55 (95% CI, 3.04, 4.06) and 4.59 (95% CI, 4.10–5.07), respectively. The NRS change difference between the groups was −1.07 (95% CI, −1.76, −0.37). The rate of recovery of neck pain (NRS score change ≥ 2 points) was significantly faster in the MSAT than in the control group (log-rank test p = 0.0055). IKM treatment combined with MSAT may be effective in reducing the pain and improving the range of motion in patients with WADs.

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Open release versus radiofrequency microtenotomy in the treatment of lateral epicondylitis: a prospective randomized controlled trial

Shoulder & Elbow ◽

10.1177/1758573217715255 ◽

2017 ◽

Vol 10 (1) ◽

pp. 45-51 ◽

Cited By ~ 5

Author(s):

Katharine Hamlin ◽

Christopher Munro ◽

Scott L. Barker ◽

Sean McKenna ◽

Kapil Kumar

Keyword(s):

Randomized Controlled Trial ◽

Grip Strength ◽

Rating Scale ◽

Numerical Rating Scale ◽

Controlled Trial ◽

Lateral Epicondylitis ◽

Open Release ◽

Randomized Controlled ◽

Prospective Randomized Controlled Trial ◽

Significant Difference

Background Optimal surgical treatment of lateral epicondylitis remains uncertain. Recently, radiofrequency microtenotomy (RFMT) has been proposed as a suitable treatment. We compared RFMT with standard open release (OR) in this prospective randomized controlled trial. Methods In total, 41 patients with symptoms for at least 6 months were randomized into two groups: 23 patients had RFMT and 18 had OR. Two patients from RFMT withdrew. Each patient underwent Numerical Rating Scale (NRS) pain score, grip strength and Disabilities of the Arm, Shoulder and Hand (DASH) scores pre-operatively and at 6 weeks. Pain and DASH scores were repeated at 6 months and 12 months. Results NRS pain scores improved by 4.8 points for RFMT and by 3.9 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Grip strength improved by 31% in the RFMT group compared to 38% in OR. There was no significant difference between the initial and 6 weeks scores or between treatments. At 1 year, DASH was 39.8 points for RFMT and 24.4 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Conclusions Both groups showed significant improvements and similar benefit to the patient. The results of the present study do not show any benefit of RFMT over the standard OR. As a result of the extra expense of RFMT, we therefore recommend that OR is offered as the standard surgical management.

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Comparison of Intravenous Lidocaine and Dexmedetomidine Infusion for Prevention of Postoperative Catheter-Related Bladder Discomfort: A Randomized Controlled Trial

10.21203/rs.2.69/v1 ◽

2018 ◽

Author(s):

Shuying Li ◽

Hui Li ◽

Juan Ni ◽

Yushan Ma

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Abdominal Hysterectomy ◽

Urinary Catheterization ◽

Intravenous Lidocaine ◽

Time Points ◽

Randomized Controlled ◽

Significant Difference ◽

Group D ◽

Dexmedetomidine Infusion

Abstract Background: Catheter-related bladder discomfort (CRBD) frequently occurs during recovery in patients who undergo intra-operative urinary catheterization distress. We conducted this study to compare the effect of intravenous lidocaine and dexmedetomidine infusion for preventing CRBD. Methods: 120 patients undergoing elective open abdominal hysterectomy and hysteromyoma requiring urinary bladder catheterization were randomly allocated into three groups of 40 each. Group L received a 2 mg/kg lidocaine bolus followed by infusion of 1.5 mg/kg/h; Group D received a 0.5 mg/kg dexmedetomidine bolus followed by infusion of 0.4 mg/kg/h; Group C received a bolus and infusion of normal saline of equivalent volume. The incidence and different severity (mild, moderate, and severe) of CRBD were assessed on arrival in the postanaesthesia care unit at 0, 1, 2, and 6 h postoperatively. Results: The incidence of CRBD was significantly lower in Group L and Group D compared with Group C at 0, 1, and 2 h. However, there was no significant difference among the three groups regarding the different severity of CRBD at all time points. The requirement of rescue tramadol for CRBD was lower in group L and group D than in group C. The incidence of sedation was significantly higher in Group D compared to Group L and Group C, though no difference in other adverse effects was observed. Conclusions: Intravenous lidocaine and dexmedetomidine infusion reduced the incidence of CRBD as well as the additional tramadol requirement for CRBD, but had no effect on the different severity of CRBD.

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Effect of Anesthesia on The Outcome of High-Grade Glioma Patients Undergoing Supratentorial Resection: Study Protocol for A Randomized Controlled Trial

10.21203/rs.3.rs-290224/v1 ◽

2021 ◽

Author(s):

Dexiang Wang ◽

Jia Dong ◽

Min Zeng ◽

Xiaoyuan Liu ◽

Xiang Yan ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Rating Scale ◽

Numerical Rating Scale ◽

Controlled Trial ◽

Tumor Resection ◽

High Grade Glioma ◽

High Grade ◽

Intravenous Anesthesia ◽

Inhalation Anesthesia ◽

Randomized Controlled

Abstract Background High-grade glioma (HGG) is the most malignant brain tumor with poor outcome. Whether anesthetic methods have impact on the outcome of these patients is still unknown. Retrospective study has found that there is no difference between two anesthesia methods on the overall survival (OS), however, intravenous anesthesia with propofol might be beneficial in subgroup patients of KPS<80. Further prospective studies are needed to evaluate the results.Methods This is a single-centered, randomized controlled, parallel group trial. 196 patients with primary HGG for tumor resection will be randomly assigned to receive either the intravenous anesthesia with propofol or inhalation anesthesia with sevoflurane. The primary outcome is the OS within 18 months. Secondary outcomes include progression-free survival (PFS), the numerical rating scale (NRS) of pain intensity and sleep quality, the postoperative encephaloedema volume, complications, the length and cost effectiveness of hospital stay of the patients.Discussion This is a randomized controlled trial to compare the effect of intravenous or inhalation anesthesia maintenance on the outcome of supratentorial HGG patients.The results will help to optimizing the anesthesia methods in these patients.Trial registration: ClinicalTrials.gov (ID: NCT02756312). Registered on 27 April 2020 https://register.clinicaltrials.gov/

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A randomized controlled trial with 4-month follow-up of adjunctive repetitive transcranial magnetic stimulation of the left prefrontal cortex for depression

Psychological Medicine ◽

10.1017/s0033291707001663 ◽

2007 ◽

Vol 38 (3) ◽

pp. 323-333 ◽

Cited By ~ 52

Author(s):

A. Mogg ◽

G. Pluck ◽

S. V. Eranti ◽

S. Landau ◽

R. Purvis ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Magnetic Stimulation ◽

Sham Group ◽

Rating Scale ◽

Repetitive Transcranial Magnetic Stimulation ◽

Controlled Trial ◽

Randomized Controlled ◽

Real Group ◽

The Mean

BackgroundEffectiveness of repetitive transcranial magnetic stimulation (rTMS) for major depression is unclear. The authors performed a randomized controlled trial comparing real and sham adjunctive rTMS with 4-month follow-up.MethodFifty-nine patients with major depression were randomly assigned to a 10-day course of either real (n=29) or sham (n=30) rTMS of the left dorsolateral prefrontal cortex (DLPFC). Primary outcome measures were the 17-item Hamilton Depression Rating Scale (HAMD) and proportions of patients meeting criteria for response (⩾50% reduction in HAMD) and remission (HAMD⩽8) after treatment. Secondary outcomes included mood self-ratings on Beck Depression Inventory-II and visual analogue mood scales, Brief Psychiatric Rating Scale (BPRS) score, and both self-reported and observer-rated cognitive changes. Patients had 6-week and 4-month follow-ups.ResultsOverall, Hamilton Depression Rating Scale (HAMD) scores were modestly reduced in both groups but with no significant group×time interaction (p=0.09) or group main effect (p=0.85); the mean difference in HAMD change scores was −0.3 (95% CI −3.4 to 2.8). At end-of-treatment time-point, 32% of the real group were responders compared with 10% of the sham group (p=0.06); 25% of the real group met the remission criterion compared with 10% of the sham group (p=0.2); the mean difference in HAMD change scores was 2.9 (95% CI −0.7 to 6.5). There were no significant differences between the two groups on any secondary outcome measures. Blinding was difficult to maintain for both patients and raters.ConclusionsAdjunctive rTMS of the left DLPFC could not be shown to be more effective than sham rTMS for treating depression.

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Comparing sensitivity to change using the 6-item versus the 17-item Hamilton depression rating scale in the GUIDED randomized controlled trial

BMC Psychiatry ◽

10.1186/s12888-019-2410-2 ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 1

Author(s):

Boadie W. Dunlop ◽

Sagar V. Parikh ◽

Anthony J. Rothschild ◽

Michael E. Thase ◽

Charles DeBattista ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Drug Interactions ◽

Active Treatment ◽

Rating Scale ◽

Controlled Trial ◽

Symptom Improvement ◽

Scale Analysis ◽

Mokken Scale Analysis ◽

Hamilton Depression Rating Scale ◽

Randomized Controlled

Abstract Background Previous research suggests that the 17-item Hamilton Depression Rating Scale (HAM-D17) is less sensitive in detecting differences between active treatment and placebo for major depressive disorder (MDD) than is the HAM-D6 scale, which focuses on six core depression symptoms. Whether HAM-D6 shows greater sensitivity when comparing two active MDD treatment arms is unknown. Methods This post hoc analysis used data from the intent-to-treat (ITT) cohort (N = 1541) of the Genomics Used to Improve DEpression Decisions (GUIDED) trial, a rater- and patient-blinded randomized controlled trial. GUIDED compared combinatorial pharmacogenomics-guided care with treatment as usual (TAU) in patients with MDD. Percent of symptom improvement, response rate and remission rate from baseline to week 8 were evaluated using both scales. Analyses were performed for the full cohort and for the subset of patients who at baseline were taking medications predicted by the test to have moderate or significant gene-drug interactions. A Mokken scale analysis was conducted to compare the homogeneity of HAM-D17 with that of HAM-D6. Results At week 8, the guided-care arm demonstrated statistically significant benefit over TAU when the HAM-D6 (∆ = 4.4%, p = 0.023) was used as the continuous measure of symptom improvement, but not when using the HAM-D17 (∆ = 3.2%, p = 0.069). Response rates increased significantly for guided-care compared with TAU when evaluated using both HAM-D6 (∆ = 7.0%, p = 0.004) and HAM-D17 (∆ = 6.3%, p = 0.007). Remission rates also were significantly greater for guided-care versus TAU using both measures (HAM-D6 ∆ = 4.6%, p = 0.031; HAM-D17 ∆ = 5.5%, p = 0.005). Patients in the guided-care arm who at baseline were taking medications predicted to have gene-drug interactions showed further increased benefit over TAU at week 8 for symptom improvement (∆ = 7.3%, p = 0.004) response (∆ = 10.0%, p = 0.001) and remission (∆ = 7.9%, p = 0.005) using HAM-D6. All outcomes showed continued improvement through week 24. Mokken scale analysis demonstrated the homogeneity and unidimensionality of HAM-D6, but not of HAM-D17, across treatment arms. Conclusions The HAM-D6 scale identified a statistically significant difference in symptom improvement between combinatorial pharmacogenomics-guided care and TAU, whereas the HAM-D17 did not. The demonstrated utility of pharmacogenomics-guided treatment over TAU as detected by the HAM-D6 highlights its value for future biomarker-guided trials comparing active treatment arms. Trial registration Clinicaltrials.gov: NCT02109939. Registered 10 April 2014.

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Effects of Bupropion on Cognitive Function in Schizophrenia: A Double Blind Randomized Controlled Trial

Global Journal of Health Science ◽

10.5539/gjhs.v9n5p67 ◽

2016 ◽

Vol 9 (5) ◽

pp. 67

Author(s):

Mansoureh Mirzadeh ◽

Najmeh Shahini ◽

Masoud Kashani Lotf Abadi ◽

Maryam Tavakoli ◽

Arash Javanbakht ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Function ◽

Rating Scale ◽

Controlled Trial ◽

Control Group ◽

P Value ◽

Double Blind ◽

Randomized Controlled ◽

Significant Difference ◽

Schizophrenic Patients

Smoking habits are common in schizophrenic patients. Nicotine can suppress negative symptoms and cognitive impairments. The aim of this study was to determine the efficacy of bupropion on cognitive function in schizophrenic patients. This study is a double blind randomized controlled trial in a large referral psychiatric university hospital in Iran. Ninety smoker schizophrenic patients were randomly allocated (based on DSM -IV TR criteria) in two groups (46 patients for case group and 44 patients in control group). They get risperidone up to 6 mg/d and bupropion up to 400 mg/d .clinical assessment (Positive and Negative Syndrome Scale (PANSS), Brief psychiatric rating scale (BPRS) were taken in beginning of study, 14th and 28th days of study. Cognitive assessment (Stroop, Digit Span, and Wechsler, Wisconsin) were taken in begging of study, the days 2nd, 7th, 14th, 28th. All data were analyzed by SPSS Ver. 17 with analytic and descriptive tests. Mean age of patients was 37.66±1.01. Mean duration of disorder was 11.63±.98 years. The scores were significantly lower at the day 28th compared to the beginning of the study in both groups in Wechsler, Stroop color word , Stroop word , Stroop color , BPRS, PANSS p value ≤0.05 .The difference between the two treatments was not significant as indicated by the effect of group, the between-subjects factor p value ≥0.05. In this study, the side effects were examined and there was no significant difference between the two groups p value ≥0.05. Augmentation of bupropion to routine treatment improves cognitive symptoms of schizophrenia in abstinence of tobacco.

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