Single dose intravenous paracetamol versus intravenous tramadol in orthopedic surgeries: A randomized study

2018 ◽  
Vol 6 (2) ◽  
pp. 23-26
Author(s):  
Sapkal Pravin S ◽  
◽  
Sandip Agarkar ◽  
Rajurkar Sampda S ◽  
◽  
...  
Keyword(s):  
Single Dose ◽  
Randomized Study ◽  
Intravenous Paracetamol

A randomized trial comparing intravenous paracetamol, topical lidocaine, and ice application for treatment of pain associated with scorpion stings

2014 ◽  
Vol 34 (6) ◽  
pp. 662-667 ◽  
Author(s):  
G Aksel ◽  
S Güler ◽  
NÖ Doğan ◽  
ŞK Çorbacioğlu
Keyword(s):  
Pain Intensity ◽  
Randomized Study ◽  
Signs And Symptoms ◽  
Treatment Modalities ◽  
Scorpion Sting ◽  
Lidocaine Group ◽  
Topical Lidocaine ◽  
Intravenous Paracetamol ◽  
Vas Scores ◽  
Scorpion Stings

Objective: Appropriate treatment for scorpion-associated pain was not previously studied in detail in the literature. The aim of this study was to compare the efficacy of three treatment modalities in patients with painful scorpion stings using visual analog scale (VAS) scores. Materials and Methods: A randomized study was carried out during a 1-year period in patients with scorpion stings who did not have any systemic signs or symptoms. Patients were treated with intravenous paracetamol, topical lidocaine, or ice application. Pain intensity was evaluated using VAS score at the time of presentation to emergency department and at 30th, 60th, 120th, and 240th minutes. Changes in VAS scores from baseline were recorded. Results: A total of 130 patients were included in the statistical analysis. Significant reduction in pain intensity was observed with topical lidocaine group when compared with the ice application group ( p < 0.001) and paracetamol group ( p < 0.001) in all selected time intervals. The median reduction in scores at 30 min after therapeutic intervention was 25.0 mm for topical lidocaine, 14.5 mm for ice application, and 10.0 mm for intravenous paracetamol. No adverse events were reported. Discussion: Our results revealed that topical lidocaine is superior to both intravenous paracetamol and local ice application and its effect lasts several hours after envenomation. conclusion: Topical lidocaine is an effective and safe treatment in scorpion sting associated with pain in patients with nonsystemic signs and symptoms.

Comparative study of the effects of zopiclone (7.5 mg), zolpidem, flunitrazepam and a placebo on nocturnal cognitive performance in healthy subjects, in relation to pharmacokinetics

1995 ◽  
Vol 10 (S3) ◽  
pp. 129s-135s ◽  
Author(s):  
H Allain ◽  
A Patat ◽  
A Lieury ◽  
F Le Coz ◽  
C Janus ◽  
...  
Keyword(s):  
Single Dose ◽  
Visual Analogue Scale ◽  
Cognitive Performance ◽  
Healthy Subjects ◽  
Analogue Scale ◽  
Randomized Study ◽  
Residual Effect ◽  
Pharmacodynamic Effect ◽  
Double Blind ◽  
Nocturnal Period

SummaryThe effect of zopiclone (7.5 mg) on attention, vigilance and memory components was evaluated during a nocturnal period in comparison to a placebo, to zolpidem (10 mg) and to flunitrazepam (1 mg) in a double blind, randomized study, after administration of a single dose in 16 young healthy volunteers. It appears that there is a clear effect on attention and vigilance; this effect is apparent during the kinetic phase of the absorption of the medication. The effect on memory is transient and is absent four hours after the ingestion of the drug. The objective results are not strictly consistent with the chronology of the subjective parameters (Leeds scale — Visual Analogue Scale). The three hypnotics under comparison do not fundamentally differ except in their kinetic/pharmacodynamic effect relationship. One important fact, taking the parameters as a whole, is that there is no objective “residual” effect.

scholarly journals Bioequivalence of levamlodipine besylate tablets in healthy Chinese subjects: A single-dose and two-period crossover randomized study

2020 ◽  
Author(s):  
Li Xin ◽  
Chenjing Wang ◽  
Ting Li ◽  
Yanping Liu ◽  
Shuqin Liu ◽  
...  
Keyword(s):  
Single Dose ◽  
Randomized Study ◽  
Pharmacokinetic Parameters ◽  
Reference Formulation ◽  
High Fat ◽  
Fasting Condition ◽  
Test Formulation ◽  
Healthy Chinese ◽  
Chinese Subjects ◽  
Fat Meal

Abstract Background: Levamlodipine, a calcium channel blocker, is used in treatment of hypertension. To compare the pharmacokinetic parameters between levamlodipine test formulation at a single dose of 5 mg and amlodipine reference formulation at a single dose of 10 mg, the bioequivalence study was carried out.Methods: A single-dose randomized, open-label, two-period crossover study was designed in healthy Chinese subjects. 48 subjects were divided into fasting and high-fat meal group equally. The subjects randomly received the test or reference formulations at the rate of 1:1. Following a 21-day washout period, the alternative formulations were received. The blood samples were collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours later. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) was applied to determine levamlodipine in the plasma samples.Results: Within equivalence limits between 80 ~ 125%, the test formulation and the reference formulation were bioequivalent, with the 90% confidence intervals (CIs) for the ratio of geometric means of Cmax, AUC0-t, and AUC0-∞. The data were shown as Cmax (89.59% ~ 101.61%), AUC0-t (87.83% ~ 94.87%) and AUC0-∞ (86.28% ~ 93.49%) under fasting condition, Cmax (90.93% ~ 102.37%), AUC0–t (95.75% ~ 104.93%) and AUC0–∞ (95.36% ~ 105.33%) under high-fat meal condition. Serious adverse event was not observed.Conclusions: The trial confirmed that levamlodipine at a single dose of 5 mg and amlodipine at a single dose of 10 mg were bioequivalent under both fasting condition and high-fat meal condition.Trial registration: Cinicaltrials, NCT04411875. Registered 3 June 2020 - Retrospectively registered, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0009W1Q&selectaction=Edit&uid=U00050YQ&ts=3&cx=-6iqkm8

scholarly journals Bioequivalence of levamlodipine besylate tablets in healthy Chinese subjects: A single-dose and two-period crossover randomized study

2020 ◽  
Author(s):  
Li Xin ◽  
Chenjing Wang ◽  
Ting Li ◽  
Yanping Liu ◽  
Shuqin Liu ◽  
...  
Keyword(s):  
Single Dose ◽  
Randomized Study ◽  
Plasma Concentrations ◽  
Bioequivalence Study ◽  
Pharmacokinetic Parameters ◽  
Open Label ◽  
Liquid Chromatography Tandem Mass ◽  
The Mean ◽  
Healthy Chinese ◽  
Chinese Subjects

Abstract Background: Levamlodipine, a calcium channel blocker, has been show act as a cardiovascular drug. To compare the pharmacokinetic parameters between levamlodipine (test formulation) at a single dose of 5 mg and amlodipine (reference formulation) at a single dose of 10 mg, the bioequivalence study was carried out.Methods: A single-dose randomized, open-label, two-period crossover study was designed in healthy Chinese subjects. 48 subjects were divided into fasted and fed groups equally. The subjects randomly received the test or reference formulations at the rate of 1:1. Following a 21-day washout period, the alternative formulations were received. The blood samples were collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168 hours later. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) was applied to determine the plasma concentrations of levamlodipine. Adverse events were recorded.Results: The 90% confidence intervals (CIs) of the ratio of geometric means (GMRs) of Cmax, AUC0-t, and AUC0-∞ under both fasted and fed conditions were within the prespecified bioequivalence limits between 80~125%. Under fasted conditions, 24 subjects were enrolled and completed the study. The mean Cmax was (2.70±0.49) ng/mL, AUC0-t was (141.32±36.24) ng×h/mL and AUC0-∞ was (157.14±45.65) ng×h/mL after a single dose of 5 mg levamlodipine. The mean Cmax was (2.83±0.52) ng/mL, AUC0-t was (153.62±33.96) ng×h/mL and AUC0-∞ was (173.05±41.78) ng×h/mL after a single dose of 10 mg amlodipine. Under fed conditions, 24 subjects were enrolled and completed the study. The mean Cmax was (2.73±0.55) ng/mL, AUC0-t was (166.93±49.96) ng×h/mL and AUC0-∞ was (190.99±70.89) ng×h/mL after a single dose of 5 mg levamlodipine. The mean Cmax was (2.87±0.81) ng/mL AUC0-t was (165.46±43.58) ng×h/mL and AUC0-∞ was (189.51±64.70) ng×h/mL after a single dose of 10 mg amlodipine. Serious adverse event was not observed.Conclusion: The trial confirmed that levamlodipine at a single dose of 5 mg and amlodipine at a single dose of 10 mg were bioequivalent under both fasted condition and fed condition.Trial registration: Cinicaltrials, NCT04411875. Registered 3 June 2020 - Retrospectively registered, https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0009W1Q&selectaction=Edit&uid=U00050YQ&ts=3&cx=-6iqkm8

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