The Effects of Ondansetron on the Analgesic Action of Intravenous Acetaminophen after Tonsillectomy in Children: A Triple-Blind Randomized Controlled Trial

Introduction. Severe pain, nausea, and vomiting after tonsillectomy surgery are among the issues that not only affect patient satisfaction but also may result in complications and delay patient discharge. This study was conducted to assess the effect of intravenous administration of ondansetron on the analgesic action of intravenous acetaminophen after tonsillectomy in children. Materials and methods. This randomized controlled trial was conducted on 53 children between the age of 3 and 12 years old who were referred to Besat Hospital Hamadan, Iran, for tonsillectomy. Patients were randomly assigned to two groups. The intervention group (I) received intravenous acetaminophen plus 0.1 mg/kg ondansetron intravenously while the control group (C) received intravenous acetaminophen plus 2 ml of normal saline intravenously. Postoperative pain severity was assessed using the Children’s Hospital Eastern Ontario Pain Scale (CHEOPS). Frequency of nausea, vomiting, and need for analgesic was assessed and recorded four times, at recovery unit, after 6, 12, and 24 hours postsurgery. Data analysis was performed at 95% confidence level using the statistical package for social sciences (SPSS) software version 21. Results. The number of patients in groups I and C was 27 and 26 patients, respectively. Mean pain score in I and C groups was 4.48 and 2.88 at recovery unit, 2.74 and 2.04 after 6 hours, 1.67 and 0.81 after 12 hours, and 0.67 and 0.20 after 24 hours postsurgery, respectively. Frequency of nausea at recovery unit was 23.1% in I group and 0.0% in group C ( p = 0.010 ) while the mean number of analgesic requirements in I and C groups was 1.07 and 0.56 times, respectively ( p = 0.027 ). Conclusions. Intravenous administration of 0.1 mg/kg ondansetron reduces the analgesic action of intravenous acetaminophen after tonsillectomy in 3 to 12-year-old children.

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Rapid Intervention of Chlorpromazine and Promethazine for Hibernation-Like Effect in Stroke: Rationale, Design, and Protocol for a Prospective Randomized Controlled Trial

Frontiers in Neurology ◽

10.3389/fneur.2021.621476 ◽

2021 ◽

Vol 12 ◽

Author(s):

Shuyu Lv ◽

Wenbo Zhao ◽

Gary B. Rajah ◽

Chaitu Dandu ◽

Lipeng Cai ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Intravenous Administration ◽

Neuroprotective Effect ◽

Controlled Trial ◽

Intervention Group ◽

Intravenous Thrombolysis ◽

Control Group ◽

Short Treatment ◽

Randomized Controlled ◽

Prospective Randomized Controlled Trial

Background: Following an acute ischemic stroke (AIS), rapidly initiated reperfusion therapies [i. e., intravenous thrombolysis (IVT) and endovascular treatment (EVT)] demonstrate robust clinical efficacy. However, only a subset of these patients can benefit from these therapies due to their short treatment windows and potential complications. In addition, many patients despite successful reperfusion still have unfavorable outcomes. Thus, neuroprotection strategies are urgently needed for AIS patients. Chlorpromazine and promethazine (C+P) have been employed in clinical practice for antipsychotic and sedative purposes. A clinical study has also shown a neuroprotective effect of C+P on patients with cerebral hemorrhage and subarachnoid hemorrhage. The safety, feasibility, and preliminary efficacy of intravenous administration of C+P in AIS patients within 24 h of onset will be elucidated.Methods: A prospective randomized controlled trial is proposed with AIS patients. Participants will be randomly allocated to an intervention group and a control group with a 1:1 ratio (n = 30) and will be treated with standard therapies according to the current stroke guidelines. Participants allocated to the intervention group will receive intravenous administration of C+P (chlorpromazine 50 mg and promethazine 50 mg) within 24 h of symptom onset. The primary outcome is safety (mainly hypotension), while the secondary outcomes include changes in functional outcome and infarction volume.Discussions: This study on Rapid Intervention of Chlorpromazine and Promethazine for Hibernation-like Effect in Stroke (RICHES) will be the first prospective randomized controlled trial to ascertain the safety, feasibility, and preliminary efficacy of intravenous C+P as a neuroprotection strategy in AIS patients. These results will provide parameters for future studies, provide insights into treatment effects, and neuroprotection with phenothiazine in AIS.Clinical Trial Registration:www.chictr.org.cn, identifier: ChiCTR2000038727.

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EXPRESS: Bufei Huoxue Capsules in the management of convalescent COVID-19 infection: study protocol for a multicentre, double-blind, and randomized controlled trial

Pulmonary Circulation ◽

10.1177/20458940211032125 ◽

2021 ◽

pp. 204589402110321

Author(s):

Yuqin Chen ◽

Wenjun He ◽

Wenju Lu ◽

Yue Xing ◽

Jianling Bai ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Blood Stasis ◽

Blood Stasis Syndrome ◽

Small Scale ◽

Control Group ◽

Cumulative Number ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Number Of Patients

Up to the 30th May, 2021, the cumulative number of patients diagnosed with Corona Virus Disease-19 (COVID-19) globally has exceeded 170 million, with more than 152 million patients recovered from COVID-19. However, the long-term effect of the virus infection on the human bodyâs function is unknown for convalescent patients. It was reported that about 63% of COVID-19 patients had observable lung damage on CT scans after being released from the hospital. Bufei Huoxue Capsules (BFHX), including three active ingredients of traditional Chinese herbal medicine, has been used clinically to prevent and treat pulmonary heart diseases with Qi deficiency and blood stasis syndrome. Some small-scale clinical trials have found that BFHX can improve lung ventilation function, reduce blood viscosity, and improve cardiopulmonary function. However, the efficacy and safety of BFHX in the treatment of the recovery phase of COVID-19 are unknown. This study is a multicentre, double-blinded, randomized, controlled trial. Subjects with convalescent COVID-19 were randomized (1:1) into either a BFHX or control group and observed for 3months concomitant with receiving routine treatment. The primary efficacy indicators are the evaluation results and changes of the St. Georgeâs Respiratory Questionnaire (SGRQ) score, Fatigue Assessment Inventory (FAI), and 6-minute walk distance (6MWD). Based on the intention-to-treat (ITT) principle, all randomly assigned participants will be included in the statistical analysis. The last visitâs outcomes will be used as the final outcomes for participants who prematurely withdraw from the trial. Per protocol set will pick up from the full analysis set for analysis. Efficacy analysis will be performed on the ITT datasets and per-protocol datasets. Prior to participation, all subjects provided written informed consent. Results will be disseminated at medical conferences and in journal publications. We aimed to determine the efficacy and safety of BFHX for the treatment of the convalescent COVID-19 patients.

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Randomized Controlled Trial of Modified Radical Mastectomy with and Without Quilting Technique and Its Effect on Seroma Formation

10.47363/jsar/2021(2)122 ◽

2021 ◽

pp. 1-4

Author(s):

Munazzah Aziz ◽

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Radical Mastectomy ◽

Seroma Formation ◽

Control Group ◽

Modified Radical Mastectomy ◽

Randomized Controlled ◽

Group I ◽

Flap Fixation ◽

Group Ii

Objective: To determine the frequency of seroma formation after flap fixation by quilting technique in MRM patients as compared to control group. Study Design: Randomized controlled trial. Place and Duration of study: This study was conducted from 11th November ,2017 to 10th May , 2018 in Department of Surgery, Holy family Hospital, Rawalpindi. Patients and Method: A total of 60 patients were included in the study having histologically proven breast cancer stage 2 or 3 in age group of 40-70 years undergoing modified radical mastectomy. Patients were allocated to group1 or 2 by random selection. In group I patients, flap fixation was done by quilting technique during MRM . In group II , no quilting was done. Post operative follow up was done after 05 days in OPD and development of seroma was observed clinically. Results: Mean age of patients was 55.23 ± 7.94 years. Mean BMI was 30.05 ± 2.63 kg/m2. Seroma formation was seen in 04 patients (13.33%) in group I (flap fixation by quilting technique ) and 19 patients (63.33%) in group II (control group) with p-value of 0.0001. Conclusion: This study concluded that there is significantly low incidence of post mastectomy seroma formation in MRM patients with quilting technique as compared to the conventional method of wound closure in MRM

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Rapid Intravenous Glyceryl Trinitrate in Ischemic Damage (RIGID) After Stroke: Rationale, Design and Protocol for a Prospective Randomized Controlled Trial

Frontiers in Neurology ◽

10.3389/fneur.2021.693330 ◽

2021 ◽

Vol 12 ◽

Author(s):

Lipeng Cai ◽

Gary Rajah ◽

Honglian Duan ◽

Jie Gao ◽

Zhe Cheng ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Glyceryl Trinitrate ◽

Intravenous Administration ◽

Controlled Trial ◽

Intravenous Thrombolysis ◽

Control Group ◽

Ischemic Damage ◽

Randomized Controlled ◽

Prospective Randomized Controlled Trial ◽

Intravenous Glyceryl Trinitrate

Background: Despite intravenous thrombolysis and endovascular therapy for acute ischemic stroke (AIS), many survivors still have varying degrees of disability. Glyceryl trinitrate (GTN), a nitric oxide (NO) donor, has been previously reported to induce neuroprotection after AIS. The use of GTN to reduce brain damage after stroke remains yet to be elucidated. This study was designed to explore the safety, feasibility, and preliminary efficacy of intravenous administration of GTN after AIS.Methods: A prospective randomized controlled trial is proposed with AIS patients. Participants will be randomly allocated to GTN group and control group with a 1:1 ratio (n = 40). Both groups will be treated with standard therapies according to the current stroke guidelines. Participants allocated to the GTN group will receive intravenous administration of GTN (5 mg GTN in 50 ml saline at a rate of 0.4 mg/h that is continued for 12.5 h/day for 2 days) within 24 h of symptom onset. Participants allocated to the control group will receive intravenous administration at equal capacity of 0.9% normal saline (NS) (total 50 ml/day at 4 ml/h that is continued for 12.5 h/day for 2 days). The primary outcome is safety [systolic blood pressure (SBP) <110 mmHg, headache], while the secondary outcomes include changes in functional outcome and infarction volume.Discussion: Rapid Intravenous Glyceryl Trinitrate in Ischemic Damage (RIGID) is a prospective randomized controlled trial that aims to ascertain the safety, feasibility, and preliminary efficacy of intravenous GTN as a neuroprotection strategy after AIS. These results will provide parameters for future studies as well as provide insights into treatment effects. Any possible neuroprotective qualities of GTN in AIS will also be elucidated.Trial Registration:www.chictr.org.cn, identifier: ChiCTR2100046271.

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Effect of Intravenous Dexamethasone on the Duration of Labor Induction: A Randomized Controlled Trial

QJM ◽

10.1093/qjmed/hcab115.007 ◽

2021 ◽

Vol 114 (Supplement_1) ◽

Author(s):

Ahmed M Nour El-Din Hashad ◽

Amr H Yehia ◽

Amany A Mohammed

Keyword(s):

Randomized Controlled Trial ◽

Statistical Difference ◽

Controlled Trial ◽

Mode Of Delivery ◽

Labor Induction ◽

Control Group ◽

Term Pregnancy ◽

Significant Statistical Difference ◽

Randomized Controlled ◽

Group I

Abstract Background Induction of labor is one of the most common interventions practiced in modern obstetrics. In the developed World, the ability to induce labor has contributed to the reduction in maternal and perinatal mortality and morbidity. Aim of the work to establish whether Dexamethasone plays a role in shorting the duration interval between initiation of labor induction and beginning of true contraction of labor in post-term pregnancy, so shorting the duration of labor. Patients and Methods This randomized controlled trial study was conducted in the labor ward of Ain Shams University Maternity Hospital on one hundred thirty five pregnant women with full term pregnancy divided into the following: Group I (Dexamethasone group) injected with 2 ml (8 mg) of the product (dexamethasone) 4 hours before initiation of labor induction and Group II (Control group) received 2 ml saline (as a placebo). Results There was a non-significant statistical difference between the two studied groups as regards the age, gestational age on admission, body mass index (BMI), Bishop Score, mode of delivery and Apgar score. There was a high significant statistical difference between the two studied groups as regards Induction- delivery interval, induction-contraction, contraction – delivery interval were shorter in cases of study than control. Conclusion From the above data we can conclude that the intravenous administration of dexamethasone appear to shorten labor duration.

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Comparison of Interactive Education Versus Fluorescent Concretization on Hand Hygiene Compliance Among Primary School Students: A Randomized Controlled Trial

The Journal of School Nursing ◽

10.1177/1059840518785447 ◽

2018 ◽

Vol 35 (5) ◽

pp. 337-347 ◽

Cited By ~ 6

Author(s):

Emine Öncü ◽

Sümbüle Köksoy Vayısoğlu ◽

Diğdem Lafci ◽

Dilek Yurtsever ◽

Ebru Ravlı Bulut ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Hand Hygiene ◽

Controlled Trial ◽

Control Group ◽

Primary School Students ◽

School Students ◽

Randomized Controlled ◽

Interactive Education ◽

Group I ◽

Group Ii

Hand hygiene for children is crucial to keep them healthy. The purpose of the study was to evaluate the effects of two educational initiatives on “handwashing effectiveness (HWE).” A randomized controlled trial was carried out during April/June 2016, and 96 primary school students were randomly assigned to Group I receiving education with fluorescent gel; Group II receiving interactive education or control group continuing its normal education. Evaluation was made by scoring the fluorescent areas on the hands with photographs. There were significant differences in handwashing scores between preprogram and postprogram for all areas in only Group II ( p < .05). HWE increased from 17.9% to 18.4% in Group I, from 15.4% to 37.7% in Group II, and from 35.5% to 35.8% in control group. Only concretization with fluorescent gel is not a sufficiently strong motivator for increasing HWE. New techniques should be integrated into the training programs for children.

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Premedication with dexmedetomidine to reduce emergence agitation: a randomized controlled trial

10.21203/rs.2.9493/v2 ◽

2019 ◽

Author(s):

Jong Chan Kim ◽

Jihee Kim ◽

Hayeon Kwak ◽

So Woon Ahn

Keyword(s):

Randomized Controlled Trial ◽

Bone Fracture ◽

Closed Reduction ◽

Controlled Trial ◽

Nasal Bone ◽

Control Group ◽

Emergence Agitation ◽

Point Scale ◽

Randomized Controlled ◽

Number Of Patients

Abstract Background: Nasal bone fracture is the most common type of facial fracture, and the high incidence of severe emergence agitation occurring after closed reduction of the nasal bone fracture can be challenging to manage. The purpose of this trial was to evaluate whether pre-operative administration of dexmedetomidine is effective in reducing the incidence and severity of emergence agitation in adults undergoing closed reduction of nasal bone fractures. Methods: In this randomized controlled trial, 90 patients who were scheduled to undergo closed reduction of a nasal bone fracture were prospectively included and were randomly assigned to either the control group (n = 45; 0.9% saline infusion) or the dexmedetomidine group (n = 45; 1 mcg/kg over 10 minutes, pre-operatively). The primary endpoint was Aono's four-point scale after anesthesia. The recovery time and numeric rating scale score were assessed as secondary endpoints. Results: Aono's four-point scale scores were lower in the dexmedetomidine group than in the control group (median: 1 [1-1] vs. 1 [1-2], 95% comfidence interval of difference: 0.01 to 0.02, P = 0.02). The number, severity, and duration of agitation episodes were significantly lower in the dexmedetomidine group than in the control group. Furthermore, the number of patients exhibiting intraoperative movement was lower in the dexmedetomidine group. Conclusions: Pre-operative administration of dexmedetomidine demonstrated several significant benefits, such as a lower incidence of emergence agitation, reduced agitation severity, and a shorter duration of agitation. Additionally, we observed more stable maintenance of intraoperative anesthesia with less movement during the surgery.

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Premedication with dexmedetomidine to reduce emergence agitation: a randomized controlled trial

10.21203/rs.2.9493/v1 ◽

2019 ◽

Author(s):

Jong Chan Kim ◽

Jihee Kim ◽

Hayeon Kwak ◽

So Woon Ahn

Keyword(s):

Randomized Controlled Trial ◽

Bone Fracture ◽

Closed Reduction ◽

Controlled Trial ◽

Nasal Bone ◽

Control Group ◽

Emergence Agitation ◽

Point Scale ◽

Randomized Controlled ◽

Number Of Patients

Abstract Background Nasal bone fracture is the most common type of facial fracture, and the high incidence of severe emergence agitation occurring after closed reduction of the nasal bone fracture can be challenging to manage. The purpose of this trial was to evaluate whether pre-operative administration of dexmedetomidine is effective in reducing the incidence and severity of emergence agitation in adults undergoing closed reduction of nasal bone fractures. Methods In this randomized controlled trial, 90 patients who were scheduled to undergo closed reduction of a nasal bone fracture were prospectively included and were randomly assigned to either the control group (n = 45; 0.9% saline infusion) or the dexmedetomidine group (n = 45; 1 mcg/kg over 10 minutes, pre-operatively). The primary endpoint was Aono's four-point scale after anesthesia. The recovery time and numeric rating scale score were assessed as secondary endpoints. Results Aono's four-point scale scores were lower in the dexmedetomidine group than in the control group [median (IQR); 1 (1-1) vs. 1 (1-2), 95% CI of difference; 0.01 to 0.02, P = 0.02]. The number, severity, and duration of agitation episodes were significantly lower in the dexmedetomidine group than in the control group. Furthermore, the number of patients exhibiting intraoperative movement was lower in the dexmedetomidine group. Conclusions Pre-operative administration of dexmedetomidine demonstrated several significant benefits, such as a lower incidence of emergence agitation, reduced agitation severity, and a shorter duration of agitation. Additionally, we observed more stable maintenance of intraoperative anesthesia with less movement during the surgery.

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Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

10.2196/preprints.13973 ◽

2019 ◽

Author(s):

Sarah Dineen-Griffin ◽

Victoria Garcia Cardenas ◽

Kylie Williams ◽

Shalom Isaac Benrimoj

Keyword(s):

Randomized Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Self Care ◽

Cluster Randomized Controlled Trial ◽

Control Group ◽

Community Pharmacies ◽

Randomized Controlled ◽

Minor Ailments ◽

Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

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Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

10.2196/preprints.16141 ◽

2019 ◽

Author(s):

Jan van Lieshout ◽

Joyca Lacroix ◽

Aart van Halteren ◽

Martina Teichert

Keyword(s):

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Community Pharmacies ◽

Web Based ◽

Randomized Controlled ◽

Tailored Interventions ◽

Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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