scholarly journals P125: Low dose intravenous ketorolac in renal colic, a pilot randomized controlled trial

CJEM ◽  
2020 ◽  
Vol 22 (S1) ◽  
pp. S109-S110
Author(s):  
J. Chao ◽  
P. Brasher ◽  
K. Cheung ◽  
R. Sharma ◽  
K. Badke ◽  
...  
Keyword(s):  
Dose Group ◽  
Low Dose ◽  
Renal Colic ◽  
Standard Dose ◽  
Controlled Trial ◽  
Pain Reduction ◽  
Primary Objective ◽  
Recruitment Rate ◽  
Convenience Sample ◽  
Increased Risk

Introduction: Non-steroidal anti-inflammatory drugs (NSAIDs) are first-line analgesics for emergency department (ED) patients with renal colic. Lower doses of intravenous (IV) ketorolac may provide similar pain relief to standard dosing in patients with acute pain. Patients with renal colic may be at increased risk of acute kidney injury; exposing them to lower doses of NSAIDs may put them at lower risk while providing equally effective analgesia. We conducted a pilot study to determine the feasibility of a randomized trial comparing the effectiveness and safety of low with standard ketorolac dosing in ED patients with suspected renal colic. The primary objective was to demonstrate the ability to achieve an enrolment target of 2 patients per week. Methods: We enrolled a convenience sample of adults presenting to an academic urban ED with unilateral flank pain suspected to be renal colic. We randomized patients to 10 mg (low dose, intervention) or 30 mg (standard dose, control). Participants, treating physicians and nurses, and researchers were blinded to treatment allocation. Our main feasibility outcome was the recruitment rate. Secondary outcomes were changes in pain scores (0-10) at 30 and 120 minutes post-ketorolac administration, vital signs, adverse events and ED length of stay. Results: We approached 82 patients, of whom 47 (57.3%) were eligible. Of these, 36 consented to participating and 30 were randomized. The proportion of screened patients who were enrolled was 36.6% (30/82). We completed enrolment over a 21-week period, with an average recruitment rate of 1.5 patients/week (range 0-4). The average baseline pain score for all participants was 6.9 (SD = 2.1). At 30 minutes post-ketorolac administration, the low dose group had a mean pain reduction of 2.0 points compared to a pain reduction of 1.7 in standard dose group (difference = 0.3, 90% CI: -0.7 to 1.4). Conclusion: These preliminary results support the possibility that low dose ketorolac may be efficacious in this patient population. We did not meet our target recruitment of 2 patients per week as this was primarily due to restricted recruitment hours. To successfully conduct a larger trial, we would need to expand both recruitment hours and the number of sites.

Double-Blind Comparison of Half-Dose and Standard-Dose Flupenthixol Decanoate in the Maintenance Treatment of Stabilised Out-Patients with Schizophrenia

1987 ◽  
Vol 151 (5) ◽  
pp. 634-638 ◽  
Author(s):  
D. A. W. Johnson ◽  
J. M. Ludlow ◽  
K. Street ◽  
R. D. W. Taylor
Keyword(s):  
Dose Reduction ◽  
Dose Group ◽  
Maintenance Treatment ◽  
Low Dose ◽  
Standard Dose ◽  
Controlled Trial ◽  
Social Function ◽  
Double Blind ◽  
Blind Comparison ◽  
Flupenthixol Decanoate

A double-blind controlled trial of 50% dose reduction in maintenance treatment in stable out-patients with low BPRS scores and good social function shows a significantly higher relapse rate in the low-dose group at 12 months (P < 0.05). After an interval of 24–36 months from dose reduction, 56–76% had experienced a relapse and 76–79% had resumed their former dosage. No clear advantage was shown for the lower dose in either a reduction of side-effects or improved social function, but a reduced prevalence or lower rate of symptom emergence for tardive dyskinesia was suggested.

scholarly journals Intermediate vs Standard-dose Prophylactic Anticoagulation in Patients with COVID-19 Admitted to ICU: Ninety-day Results from the INSPIRATION Trial

2021 ◽  
Author(s):  
Behnood Bikdeli ◽  
Azita H Talasaz ◽  
Farid Rashidi ◽  
Hooman Bakhshandeh ◽  
Farnaz Rafiee ◽  
...  
Keyword(s):  
Hospital Discharge ◽  
Major Bleeding ◽  
Arterial Thrombosis ◽  
Dose Group ◽  
Standard Dose ◽  
Controlled Trial ◽  
Bleeding Events ◽  
Major Bleeding Events ◽  
Prophylactic Anticoagulation ◽  
Intermediate Dose

Background: Thrombotic complications are considered among the main extrapulmonary manifestations of COVID-19. The optimal type and duration of prophylactic antithrombotic therapy in these patients remain unknown. Methods: This manuscript reports the final (90-day) results of the Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) study. Patients with COVID-19 admitted to intensive care were randomized to intermediate-dose versus standard-dose prophylactic anticoagulation for 30 days, irrespective of hospital discharge status. The primary efficacy outcome was a composite of adjudicated venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation (ECMO), or all-cause death. The main safety outcome was major bleeding. Results: Of 600 randomized patients, 562 entered the modified intention-to-treat analysis (median age [Q1, Q3]; 62 (50, 71) years; 237 (42.2%) women), of whom 336 (59.8%) survived to hospital discharge. The primary outcome occurred in 132 (47.8%) of patients assigned to intermediate-dose and 130 (45.4%) patients assigned to standard-dose prophylactic anticoagulation (hazard ratio [HR]: 1.21, 95% confidence interval [CI]: 0.95-1.55, P=0.11). No significant differences were observed between the two groups for other efficacy outcomes, or in the landmark analysis from days 31-90. Overall, there were 7 (2.5%) major bleeding events in the intermediate-dose group (including 3 fatal events) and 4 (1.4%) major bleeding events in the standard-dose group (none fatal) (HR: 1.82, 95% CI: 0.53-6.24, P=0.33). Conclusion: Intermediate-dose compared with standard-dose prophylactic anticoagulation did not reduce a composite of death, treatment with ECMO, or venous or arterial thrombosis at 90-day follow-up.

Low-Dose (0.05 Unit/kg/hour) vs Standard-Dose (0.1 Unit/kg/hour) Insulin in the Management of Pediatric Diabetic Ketoacidosis: A Randomized Double-Blind Controlled Trial

2021 ◽  
Vol 58 (7) ◽  
pp. 617-623
Author(s):  
Ramachandran Rameshkumar ◽  
Ponnarmeni Satheesh ◽  
Puneet Jain ◽  
Jagadeesh Anbazhagan ◽  
Shilpa Abraham ◽  
...  
Keyword(s):  
Diabetic Ketoacidosis ◽  
Low Dose ◽  
Standard Dose ◽  
Controlled Trial ◽  
Double Blind

Comparative Analysis on Low- and Standard-Dose Regimes of Alteplase Thrombolytic Therapy for Acute Ischemic Stroke: Efficacy and Safety

2017 ◽  
Vol 79 (1-2) ◽  
pp. 68-73 ◽  
Author(s):  
Guangjian Zhao ◽  
Tingfen Huang ◽  
Mei Zheng ◽  
Yansen Cui ◽  
Yunyong Liu ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Thrombolytic Therapy ◽  
Acute Ischemic Stroke ◽  
Dose Group ◽  
Low Dose ◽  
Standard Dose ◽  
Efficacy And Safety ◽  
Significant Difference ◽  
Symptomatic Intracranial Hemorrhage ◽  
Intravenous Alteplase

Objective: This study analyzed the efficacy and safety of low-dose and standard-dose alteplase intravenous thrombolytic therapy for acute ischemic stroke (AIS). Methods: Patients with AIS who underwent intravenous alteplase thrombolysis from July 2012 to December 2016 were retrospectively analyzed and correspondingly divided into low-dose (0.6–0.89 mg/kg) group and standard-dose group (0.9 mg/kg) according to alteplase dosage. The clinical outcome was evaluated by modified Rankin Scale (mRS) at 90 days after onset. The safety index was the mortality at 90 days after onset and the incidence of symptomatic intracranial hemorrhage (SICH) within 7 days. Results: A total of 1,486 patients were included (1,115 cases in low-dose group and 371 cases in standard-dose group). There were no significant differences in baseline data between the 2 groups. As mRS, good outcome rate as well as mortality rate in both groups had no significant difference (36.1 vs. 37.6%; χ2 = 10.882, p = 0.890; 5.5 vs. 7.3%; χ2 = 2.163, p = 0.076), but the incidence of SICH in low-dose group was significantly lower than that of the standard-dose group (2.2 vs. 5.9%; χ2 = 3.157, p = 0.001). Conclusion: The efficacy of low-dose alteplase intravenous thrombolytic therapy for AIS was equivalent to the standard-dose regimen but with higher safety.

scholarly journals Protocol for a factorial randomised controlled trial, embedded within WHiTE 8 COPAL, of an Enhanced Trainee Principal Investigator Package and Additional Digital Nudge to increase recruitment rates

F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 1153 ◽  
Author(s):  
Nickil Agni ◽  
Caroline Fairhurst ◽  
Catriona McDaid ◽  
Mike Reed ◽  
David Torgerson
Keyword(s):  
Randomised Controlled Trial ◽  
Positive Reinforcement ◽  
Controlled Trial ◽  
Significant Proportion ◽  
Educational Programme ◽  
Primary Objective ◽  
Recruitment Rate ◽  
Principal Investigators ◽  
Link Type ◽  
Randomised Controlled

Recruitment remains an issue when conducting randomised controlled trials (RCTs) with a significant proportion of studies failing to reach their target sample size. Studies evaluating interventions to improve recruitment aimed specifically at recruiters to the trial are limited in number. This factorial RCT will evaluate the effectiveness of an educational intervention to trainee principal investigators and a positive reinforcement intervention via an email nudge on increasing recruitment. The targeted recruiters will be in 20 centres nationally recruiting to one large orthopaedic randomised controlled trial, WHiTE 8 COPAL. Centres will be randomised via minimisation to one of four groups. The primary outcome is recruitment rate in the first six months that a centre is actively recruiting, with data being analysed via a Poisson regression model. Results will be presented as adjusted incidence rate ratios with 95% confidence intervals. Secondary outcomes relate to the feasibility and logistics of running the interventions.  We will also collect feedback regarding the educational programme set out for the trainee principal investigators. The study started in August 2018 with the anticipation of the primary objective endpoint by October 2019. The results of this study will be used to inform the design of future RCTs, particularly in orthopaedics in the UK, where the role of Trainee Principal Investigators is now a consistent one across different trials. Trial registration: 11600053, ISRCTN, 20/08/2018; SWAT 67, Northern Ireland Hub for Trials Methodology Research SWAT repository, 01/10/2017.

scholarly journals Effect of low-dose lidocaine on objective upper extremity strength and immediate pain relief following cervical interlaminar epidural injections: a double-blinded randomized controlled trial

2020 ◽  
Vol 45 (10) ◽  
pp. 767-773
Author(s):  
Zachary L. McCormick ◽  
Taylor Burnham ◽  
Shellie Cunningham ◽  
Richard W Kendall ◽  
David Bougie ◽  
...  
Keyword(s):  
Pain Relief ◽  
Upper Extremity ◽  
Low Dose ◽  
Controlled Trial ◽  
Pain Reduction ◽  
Radicular Pain ◽  
Spinal Block ◽  
Epidural Injections ◽  
Significant Difference ◽  
Double Blinded

BackgroundLow-dose lidocaine is a common diluent for analgesia following cervical interlaminar epidural steroid injection (CIESI). Concerns with this practice exist. A single-arm cohort reported that 20% of patients develop postprocedural upper extremity weakness when using lidocaine as a diluent. Furthermore, a high-cervical spinal block with unintended intrathecal or subdural administration is possible.ObjectiveDetermine if low-dose lidocaine as a diluent during CIESI causes clinically meaningful (1) upper extremity weakness and (2) immediate pain relief when compared with saline.DesignDouble-blinded randomized control trial.MethodsPatients with cervical radicular pain scheduled for CIESI were enrolled. Participants received lidocaine (CIESI-L) or saline (CIESI-S) as a diluent for the epidural injectate. Myotomal strength was measured with dynamometry before and between 20 and 30 min after CIESI. Pre-pain and post-pain scores were obtained. Primary and secondary outcomes were post-CIESI weakness of ≥20% (minimal clinically important difference (MCID)) in >1 myotome and ≥50% pain reduction on the numerical scale.Results120 participants (64 females (53%), mean age, 56 (SD 13.7) years) completed the study and were analyzed (CIESI-L n=60; CIESI-S n=60). There was no significant between-group difference in the proportion of participants with postprocedural weakness, CIESI-L 41.7% (95% CI, 29.8% to 54.5%), CIESL-S 50% (95% CI, 37.5% to 62.5%). Between-group comparison showed no significant difference in pain reduction, relative risk 1.53 (95% CI, 0.82 to 2.86).ConclusionLow-dose lidocaine as a diluent in CIESI does not significantly increase the risk of post-CIESI myotomal weakness when compared with saline, but also does not substantially increase the likelihood of immediate, meaningful pain relief.Trial registration detailsClinicalTrials.gov (NCT03127137); December 26, 2017.

Comparative efficacy of reduced or standard doses of lenograstim for peripheral blood stem cell mobilization and transplantation: A randomized study in patients undergoing autologous peripheral stem cell transplantation

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 7099-7099
Author(s):  
M. Ozturk ◽  
F. Arpaci ◽  
S. Ataergin ◽  
A. Ozet ◽  
T. Cetin ◽  
...  
Keyword(s):  
Stem Cell ◽  
Peripheral Blood ◽  
Dose Group ◽  
Low Dose ◽  
Peripheral Blood Stem Cell ◽  
Standard Dose ◽  
Randomized Study ◽  
Median Number ◽  
Cd34 Cells ◽  
Pbsc Mobilization

7099 Background: 10 microg/kg/day of filgrastim and lenograstim have been recommended for mobilization of CD34+ cells without associated chemotherapy. However,in our previous randomized study we demonstrated that a 7.5 microg/kg/day dose of lenograstim has been as efficacious as 10 microg/kg/day of filgrastim. In this study, we investigated whether a reduced dose of lenograstim is equavalent to standard dose for autologous peripheral blood stem cell (PBSC) mobilization and transplantation. Methods: A total of 49 consecutive patients were randomized to either low dose (7.5 microg/kg/day, n = 24) or standard dose (10 microg/kg/day, n = 25) of lenograstim. These two groups were similar in regard to disease, sex, body weight, body surface area, conditioning regimens, previous chemotherapy cycles and radiotherapy. Each dose of lenograstim was administered for 4 consecutive days. The first PBSC apheresis was done on the 5th day. In the posttransplant period, lenograstim was given at 5 microg/kg/day until leukocyte engraftment. Results: Successful mobilization with the first apheresis, was achieved in 10/24 (42%) patients in low dose group versus 14/25 (56%) patients in standard dose group. No significant difference was seen in the median number of CD34+cells mobilized, as well as the median number of apheresis, median volume of apheresis, percentage of CD34+ cells, and CD34+ cell number. Leukocyte and platelet engraftments, the number of days requiring G-CSF and parenteral antibiotics, the number of transfusions were similar in both groups in the posttransplant period. Conclusions: Lenograstim 7.5 microg/kg/day is as efficious as Lenograstim 10 microg/kg/day for autologous PBSC mobilization and transplantation. No significant financial relationships to disclose.

scholarly journals Prevalence of alternative diagnoses in patients with suspected uncomplicated renal colic undergoing computed tomography: a prospective study

CJEM ◽  
2015 ◽  
Vol 17 (1) ◽  
pp. 67-73 ◽  
Author(s):  
Julie Pernet ◽  
Sandra Abergel ◽  
Jerome Parra ◽  
Amine Ayed ◽  
Jerome Bokobza ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Primary Outcome ◽  
Low Dose ◽  
Renal Colic ◽  
Primary Objective ◽  
University Hospital ◽  
Future Research ◽  
Childbearing Age ◽  
Alternative Diagnosis ◽  
Unenhanced Ct

AbstractObjectivesUnenhanced computed tomography (CT) has become a standard imaging technique for uncomplicated renal colic in many countries. The appropriate timing of CT imaging has not been established, and guidelines recommend that this imaging be performed between 1 and 7 days of presentation. The primary objective of this study was to determine the prevalence of alternative diagnosis identified with low-dose unenhanced CT in the emergency department (ED) in patients with suspected uncomplicated renal colic.MethodsThis prospective single-centre study was carried out in a large university hospital ED. Over a 6-month period, all patients with clinically diagnosed renal colic and a plan to be discharged underwent low-dose unenhanced CT in the ED. Pregnant women, women of childbearing age not willing to have a pregnancy test, and patients who had already undergone diagnostic imaging were excluded. The primary outcome was the number and nature of the alternative diagnosis. Univariate analyses were performed to assess factors associated with the primary outcome.ResultsA total of 178 patients were screened, and 155 underwent CT in the ED. The mean age was 42.2 years; 69% were male. The diagnosis of uncomplicated renal colic was confirmed in 118 participants (76%); 27 (17%) had an inconclusive CT scan. Overall, 10 patients (6%; 95% confidence interval [CI] 3–10) had an alternative diagnosis, 5 of whom were subsequently hospitalized.ConclusionLow-dose unenhanced CT in the ED detects alternative diagnoses in 6% (95% CI 3–10) of patients with suspected uncomplicated renal colic, half of whom are subsequently hospitalized. Our prospective findings, which were similar to those reported in retrospective studies, are a potential argument for a systematic approach to ED imaging in suspected renal colic. Future research involving intervention and control groups would be helpful.

High-Dose Nadroparin Following Endovascular Aneurysm Treatment Benefits Outcome After Aneurysmal Subarachnoid Hemorrhage

Neurosurgery ◽  
2017 ◽  
Vol 83 (2) ◽  
pp. 281-287 ◽  
Author(s):  
Rene Post ◽  
IJsbrand A.J Zijlstra ◽  
Rene van den Berg ◽  
Bert A Coert ◽  
Dagmar Verbaan ◽  
...  
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Dose Group ◽  
Low Dose ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Controlled Trial ◽  
Delayed Cerebral Ischemia ◽  
Neurological Status ◽  
High Dose ◽  
Aneurysm Treatment ◽  
Significant Difference

Abstract BACKGROUND Delayed cerebral ischemia (DCI) is one of the major causes of delayed morbidity and mortality in patients with aneurysmal subarachnoid hemorrhage (aSAH). OBJECTIVE To evaluate the effect of high-dose nadroparin treatment following endovascular aneurysm treatment on the occurrence of DCI and clinical outcome. METHODS Medical records of 158 adult patients with an aSAH were retrospectively analyzed. Those patients treated endovascularly for their ruptured aneurysm were included in this study. They received either high-dose (twice daily 5700 AxaIE) or low-dose (once daily 2850 AxaIE) nadroparin treatment after occlusion of the aneurysm. Medical charts were reviewed and imaging was scored by 2 independent neuroradiologists. Data with respect to in-hospital complications, peri-procedural complications, discharge location, and mortality were collected. RESULTS Ninety-three patients had received high-dose nadroparin, and 65 patients prophylactic low-dose nadroparin. There was no significant difference in clinical DCI occurrence between patients treated with high-dose (34%) and low-dose (31%) nadroparin. More patients were discharged to home in patients who received high-dose nadroparin (40%) compared to low-dose (17%; odds ratio [OR] 3.13, 95% confidence interval [95% CI]: 1.36-7.24). Furthermore, mortality was lower in the high-dose group (5%) compared to the low-dose group (23%; OR 0.19, 95% CI: 0.07-0.55), also after adjusting for neurological status on admission (OR 0.21, 95% CI: 0.07-0.63). CONCLUSION Patients who were treated with high-dose nadroparin after endovascular treatment for aneurysmal SAH were more often discharged to home and showed lower mortality. High-dose nadroparin did not, however, show a decrease in the occurrence of clinical DCI after aSAH. A randomized controlled trial seems warranted.

Sign in / Sign up

Export Citation Format

Share Document