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Background: Drotaverine, a spasmolytic, has been found to have potential to achieve a reduction in the duration of labor and prevent prolonged labor. Objective: To compare the effects of intravenous drotaverine hydrochloride with placebo for shortening the duration of active phase of labor in primigravida's. Methods: A double-blind, placebo-controlled randomized trial of 246 primigravida's in active phase of labor at term was conducted. They were randomly (1:1 ratio) administered intravenous 2 ml (40mg) of drotaverine hydrochloride or 2 ml of Vitamin B complex as placebo. The primary outcome measure was the duration of active phase of labor. The secondary outcome measures were cervical dilatation rate, oxytocin augmentation rate, incidence of prolonged labor, labor pain scores, mode of delivery, maternal and neonatal outcomes. Results: The mean duration of active phase of labor (hour) was significantly lower in the drotaverine group compared to the control (drotaverine; 6.22 ± 2.41 vs placebo; 8.33 ± 3.56; p <0.001). Also, the cervical dilatation rate (cm/hr) was significantly faster in the drotaverine arm (drotaverine; 1.68 ± 1.02 versus placebo; 1.06 ± 0.53, p <0.001). There was a significantly higher probability of faster delivery among women who were given drotaverine (log-rank test, p < 0.001). The oxytocin augmentation rate, incidence of prolonged labor, labor pain scores, mode of delivery, maternal and neonatal outcomes were not significantly different among the groups. Conclusions: Drotaverine hydrochloride is effective in shortening the duration of active phase of labor without adverse maternal and neonatal outcomes. However, more evidence is needed to explore its role in active phase of labor among primigravid women. Trial registration number: PACTR201810902005232
Subject(s)
Parasympatholytics , Placebos , Clinical Laboratory Techniques , Duration of Therapy , Telomere Shortening , NigeriaABSTRACT
Background: Labor is the most perilous journey a woman has to undertake. Painless and short labor is desired by every woman and is a constant aim for obstetrician. Objective of this study was to compare the efficacy of drotaverine hydrochloride with valethamate bromide for cervical dilatation in labor in primigravida.Methods: The present study was conducted in the department of obstetrics and gynecology, S. P. Medical College and Associated Group of Hospitals, Bikaner, Rajasthan from 1st August 2018 to 31st July 2019 over a period of 1 year. Total of 300 patients were included in the study with 150 patients in each of the two groups. In this study the effects of Drotaverine hydrochloride (Group A) and Valethamate bromide (Group B) on cervical dilatation were compared.Results: In our study, the mean drug delivery interval was 101.58±78.06 mins in Group A and 134.24±94.12 mins in Group B. The mean number of doses of drug required was 1.27±0.55 in Group A and 4.17±1.62 in Group B. The difference was statistically highly significant (p <0.001).Conclusions: Drotaverine hydrochloride is found to be better than valethamate bromide in shortening the duration of active phase of labor in primigravidae. Drotaverine was found to be a better drug, hence, can be used to reduce the agony of the laboring woman without any significant side effects on the mother or the fetus.
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Camylofin dihydrochloride is an anti-spasmodic drug available in India and other Latin American and African countries, for the treatment of abdominal colic and for acceleration of labor. Although, the drug has been in use for over six decades, with multiple citations in academic text books of repute, treatment protocols, and multiple research publications, there is no consolidated published information on the pharmacology and clinical details of camylofin. This drug statement/monograph is an attempt to collate and present scientific information that will come in handy to practicing obstetricians and gynaecologists, as well as other primary care physicians, when treating cases of abdominal colic or managing prolonged labor. Approved clinical indications, clinical pharmacology, dosage, contraindications, precautions, drug interactions, adverse effects, overdose and clinical evidence in different indications are covered herein.
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This work describes a simple, rapid, and reliable HPLC method for the simultaneous determination of caffeine (CAF), dipyrone (DIP) and drotaverine hydrochloride (DRV). Chromatographic separation was achieved using a reversed phase Waters Symmetry C18 (3.9×150 mm, 5 μm particle size) column with gradient elution of the mobile phase composed of 0.05 M orthophosphoric acid and acetonitrile. The gradient elution started with 15% (by volume) acetonitrile ramped up linearly to 60% in 3 min then kept at this percentage till the end of the run. The flow rate was 1mL/min. Quantification was based on measuring peak areas at 210 nm. The analytes were resolved with retention times 1.47, 2.39 and 7.17 min for DIP, CAF and DRV, respectively. Analytical performance of the proposed procedure was validated with respect to system suitability, linearity, ranges, precision, accuracy, robustness, detection and quantification limits. The linearity ranges were 10-200, 5-100 and 5-100 μg/mL for DIP, CAF and DRV, respectively. The validated HPLC method was applied to the simultaneous determination of the three drugs in several laboratory-prepared mixtures of different ratios. Finally, laboratory made tablets containing the three drugs were assayed using the developed procedure where no interfering peaks were encountered from the tablet additives.
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@#Objective To explore the effect of Drotaverine hydrochloride on preventing bladder spasm after transurethral prostatectomy.Methods 124 patients after transurethral prostatectomy were divided into patient-controlled epidural analgesia pump group (group I, n=61) and Drotaverine hydrochloride group (group II, n=63). Group I received bupivacaine by patient-controlled epidural analgesia, and the pump was withdrawed after 72 h. Group II received Drotaverine hydrochloride by intramuscular injection, 80 mg every 12 h, and then orally taken after anal exhaust for 3 days. Bladder spasm and adverse reaction were recorded in both groups. Results There was no significant difference in bladder spasm between group I (11.48%) and group II (12.70%) (P>0.05), as well as in side reaction between group I (16.39%) and group II (17.46%) (P>0.05). Conclusion Drotaverine hydrochloride is effective on preventing bladder spasm after transurethral resection of the prostate, with small side effect.
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A new, simple, sensitive luminescence method for the determination of drotaverine hydrochloride is developed and validated. The Drotaverine hydrochloride can remarkably quench the luminescence intensity of the Tb3+ ion in terbium complex with 1-bythyl-4-hydroxy-2-oxo-1,2-dihydroquinoline-3-carboxylic acid-(4-methyl-pyridin-2- yl)-amide (R) in aqueous solutions containing urotropine buffer (pH 7.5) at λex=317 nm and λem=545 nm. Under optimal conditions, the quenching of luminescence intensity is directly proportion to the concentration of Drotaverine hydrochloride in the range of 0.5-300 μg/mL and detection limit is 0.16μg/mL. This method was applied for the determination of Drotaverine hydrochloride in tablets “No-spa”.
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A simple, rapid, reproducible, accurate and precise Reverse Phase HPLC method was developed for the quantitative simultaneous estimation of Drotaverine hydrochloride and Paracetamol in combined tablet dosage form. Drotaverine hydrochloride is an analog of papaver and is used mainly as an antispasmodic, smooth muscle relaxant. Paracetamol has analgesic and antipyretic activity. The chromatographic separation of both drugs was achieved with 250 x 4.6 mm, i.d 5 μm C-18 column using Methanol: water pH adjusted to 4.0 with O- Phosphoric acid. (60:40 v/v) at the flow rate of 1ml/min. The measurements were made at 243.0 nm using UV detector. The linearity range was found to be 5-80 μg/ml for Drotaverine hydrochloride and 5-70 μg/ml for Paracetamol. The coefficient of correlation for Drotaverine hydrochloride and Paracetamol was found to be 0.9994 and 0.9990 respectively. The retention time for Drotaverine hydrochloride and Paracetamol were 4.562 min and 8.146 min, respectively. The tailing factor for Drotaverine hydrochloride and Paracetamol was found to be 1.12 and 1.18 respectively. The percent recoveries obtained for Drotaverine hydrochloride and Paracetamol were found to be 99.85 and 99.92 respectively. The relative standard deviation for intraday and interday precision in tablet was always less than 2%. The method was validated for linearity, range, precision, accuracy, specificity, selectivity, intermediate precision, ruggedness, robustness, stability and suitability.
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Objective To evaluate the effects of drotaverine hydrochloride versus scopolamine in re-ducing duodenal motility and in facilitating cannulation during endoscopic retrograde cholangiopancreatogra-phy (ERCP). Methods Randomized controlled trial of 650 participants from 4 endoscopic centers assigned to receive scopolamine 20 mg or drotaverine hydrochloride 40 mg intravenously 15 minutes before ERCP. Pa-rameters including duodenal motility grades, success rates of deep cannulation, ERCP-related complications and adverse effects were recorded. Results The data of 638 patients (319 in each group) were valid. There were no significant differences in duodenal motility grades (1.17 ±0. 82 vs. 1.13 ± 0.89, P =0. 705), success rate of deep cannulation (90. 9% vs. 91.8%, P =0. 672) and incidence of ERCP-related complications (11.3% vs. 11.0%, P =0. 900) between 2 groups. However, the incidence of tachycardia (heart rate > 120 bpm) during ERCP was lower in drotaverine group than in scopolamine group (2. 2% vs. 6. 9%, P = 0. 004). There was no significant difference in other adverse effects (nausea, vomiting) between 2 groups. Conclusion Drotaverine hydrochloride may provide a reasonable alternative as antimotility agent before ERCP.