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

A randomized controlled trial comparing standard- and low-dose strategies for transfusion of platelets (SToP) to patients with thrombocytopenia

Blood ◽  
2009 ◽  
Vol 113 (7) ◽  
pp. 1564-1573 ◽  
Author(s):  
Nancy M. Heddle ◽  
Richard J. Cook ◽  
Alan Tinmouth ◽  
C. Tom Kouroukis ◽  
Tor Hervig ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Dose ◽  
Standard Dose ◽  
Controlled Trial ◽  
Data Safety Monitoring Board ◽  
World Health ◽  
Double Blind ◽  
Who Grade ◽  
Randomized Controlled ◽  
Platelet Transfusions

Abstract A noninferiority study was performed comparing low-dose and standard-dose prophylactic platelet transfusions. A double-blind randomized controlled trial (RCT) was performed in 6 sites in 3 countries. Thrombocytopenic adults requiring prophylactic platelet transfusion were randomly allocated to standard-dose (300-600 × 109 platelets/product) or low-dose (150- < 300 × 109 platelets/product) platelets. The primary outcome (World Health Organization [WHO] bleeding ≥ grade 2) was assessed daily through clinical examination, patient interview, and chart review. A WHO grade was assigned through adjudication. The Data Safety Monitoring Board stopped the study because the difference in the grade 4 bleeding reached the prespecified threshold of 5%. At this time, 129 patients had been randomized and 119 patients were included in the analysis (58 low dose; 61 standard dose). Three patients in the low-dose arm (5.2%) had grade 4 bleeds compared with none in the standard-dose arm. WHO bleeding grade 2 or higher was 49.2% (30/61) in the standard-dose arm and 51.7% (30/58) in the low-dose group (relative risk [RR], 1.052; 95% confidence interval [CI], 0.737-1.502). A higher rate of grade 4 bleeding in patients receiving low-dose prophylactic platelet transfusions resulted in this RCT being stopped. Whether this finding was due to chance or represents a real difference requires further investigation. These clinical studies are registered on http://www.clinicaltrials.gov as NCT00420914.

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 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.

scholarly journals Discharge Readiness after Propofol with or without Dexmedetomidine for Colonoscopy

2019 ◽  
Vol 131 (2) ◽  
pp. 279-286 ◽  
Author(s):  
Leonard U. Edokpolo ◽  
Daniel J. Mastriano ◽  
Joanna Serafin ◽  
Jeremy C. Weedon ◽  
Maryam T. Siddiqui ◽  
...  
Keyword(s):  
Bolus Dose ◽  
Low Dose ◽  
Enhanced Recovery ◽  
Controlled Trial ◽  
Positive Pressure ◽  
Double Blind ◽  
Hemodynamic State ◽  
Discharge Readiness ◽  
Recovery Protocols ◽  
Discharge Criteria

Abstract Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New Background Enhanced recovery protocols employ various approaches to minimize detrimental side effects of anesthetizing agents. The authors tested the hypothesis that adding low-dose dexmedetomidine to propofol for anesthesia in ambulatory colonoscopies, compared with propofol alone, would lower the propofol requirement, improve the intra-procedure hemodynamic state, and not increase time-to-discharge. Methods In this noninferiority, double-blind, randomized controlled trial, patients having colonoscopies received total IV anesthesia either with propofol and placebo (n = 50), or propofol and a bolus dose of dexmedetomidine, 0.3 μg/kg (n = 51). Additional propofol was administered to maintain a Bispectral Index score of 60. Following the procedure, readiness for discharge was assessed regularly using the Modified Post Anesthetic Discharge Scoring System until discharge criteria were met. The primary outcome was the percentage of patients meeting discharge criteria within 30 min from procedure end-time. Results Twenty-six of 51 (51%) patients receiving propofol-dexmedetomidine were ready for discharge by 30 min from procedure end time, compared with 44 of 50 (88%) receiving propofol (P &lt; 0.001). Propofol consumption was lower in subjects receiving propofol–dexmedetomidine (140 μg · kg-1 · min-1) compared to those receiving propofol (180 μg · kg-1 · min-1) with P = 0.011. The lowest mean arterial pressure decreased further from baseline in those receiving propofol–dexmedetomidine (−30%; mean decrease −30 ±10.5 mmHg) compared to propofol (−21%; mean decrease, −22 ± 14.2 mmHg) with P = 0.003. There was no difference in incidence of bradycardia, with sustained bradycardia occurring in 3 of 51 (6%) patients receiving propofol–dexmedetomidine compared to 1 of 50 (2%) patients receiving propofol (P = 0.62). No apnea episodes requiring positive-pressure ventilation occurred in either group. Conclusions For anesthesia in ambulatory colonoscopy, combining low-dose dexmedetomidine with propofol delayed discharge readiness and provoked hypotension compared to propofol alone.

Prevention of Opioid-Induced Nausea and Vomiting During Treatment of Moderate to Severe Acute Pain: A Randomized Placebo-Controlled Trial Comparing CL-108 (Hydrocodone 7.5 mg/Acetaminophen 325 mg/Rapid-Release, Low-Dose Promethazine 12.5 mg) with Conventional Hydrocodone 7.5 mg/Acetaminophen 325 mg

Pain Medicine ◽  
2019 ◽  
Vol 20 (12) ◽  
pp. 2528-2538
Author(s):  
John R Zuniga ◽  
Athena S Papas ◽  
Stephen E Daniels ◽  
Kyle Patrick ◽  
Derek D Muse ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Acute Pain ◽  
Low Dose ◽  
Controlled Trial ◽  
Third Molar ◽  
Nausea And Vomiting ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Rapid Release ◽  
Surgical Extraction

Abstract Objectives To evaluate the prevention of opioid-induced nausea and vomiting (OINV) and the relief of moderate to severe acute pain by CL-108, a novel drug combining a low-dose antiemetic (rapid-release promethazine 12.5 mg) with hydrocodone 7.5 mg/acetaminophen 325 mg (HC/APAP) was used. Methods This was a multicenter, randomized, double-blind, placebo- and active-controlled multidose study. After surgical extraction of two or more impacted third molar teeth (including at least one mandibular impaction), 466 patients with moderate to severe pain (measured on a categorical pain intensity scale [PI-CAT]) were randomized to CL-108, HC/APAP, or placebo. Over the next 24 hours, patients used the PI-CAT to assess pain at regular intervals whereas nausea, vomiting, and other opioid-related side effects were also assessed prospectively. Study medications were taken every four to six hours as needed; supplemental rescue analgesic and antiemetic medications were permitted. Co-primary end points were the incidence of OINV and the time-weighted sum of pain intensity differences over 24 hours (SPID24). Results Relative to HC/APAP treatment alone, CL-108 treatment reduced OINV by 64% (P &lt; 0.001). Treatment with CL-108 significantly reduced pain intensity compared with placebo (SPID24 = 16.2 vs 3.5, P &lt; 0.001). There were no unexpected or serious adverse events. Conclusions CL-108 is a safe and effective combination analgesic/antiemetic for the prevention of OINV during treatment of moderate to severe acute pain.

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