Drotaverine to shorten the duration of labour in primigravidas: a randomised, double-blind, placebo-controlled trial.

Background: Drotaverine, a spasmolytic, has been found to have potential to achieve a reduction in the duration of labour and prevent prolonged labour. Objective: To compare the effects of intravenous drotaverine hydrochloride with placebo for shortening the duration of active phase of labour in primigravidas. Methods: A double-blind, placebo-controlled randomized trial of 246 primigravidas in active phase of labour 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 labour. The secondary outcome measures were cervical dilatation rate, oxytocin augmentation rate, incidence of prolonged labour, labour pain scores, mode of delivery, maternal and neonatal outcomes. Results: The mean duration of active phase of labour (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 labour, labour 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 labour without adverse maternal and neonatal outcomes. However, more evidence is needed to explore its role in active phase of labour among primigravid women. Trial registration number: PACTR201810902005232.

Clinical Efficacy of Intracoronary Papaverine After Nicorandil Administration for Safe and Optimal Fractional Flow Reserve Measurement.

Fractional flow reserve (FFR) is considered the standard for assessment of the physiological significance of coronary artery stenosis. Intracoronary papaverine (PAP) is the most potent vasodilator used for the achievement of maximal hyperemia. However, its use can provoke ventricular tachycardia (VT) due to excessive QT prolongation. We evaluated the clinical efficacy and safety of the administration of PAP after nicorandil (NIC), a potassium channel opener that prevents VT, for optimal FFR measurement.A total of 127 patients with 178 stenoses were enrolled. The FFR values were measured using NIC (NIC-FFR) and PAP (PAP-FFR). We administered PAP following NIC (NIC-PAP). Changes in the FFR and electrogram parameters (baseline versus NIC versus PAP) were assessed and the incidence of arrhythmias after PAP was evaluated. In addition, we analyzed another 41 patients with 51 stenoses by assessing the FFR using PAP before NIC (PAP-NIC). After propensity score matching, the electrogram parameters between 2 groups were compared.The mean PAP-FFR was significantly lower than the mean NIC-FFR (0.82 ± 0.11 versus 0.81 ± 0.11, P < 0.05). The mean baseline-QTc, NIC-QTc, and PAP-QTc values were 425 ± 37 ms1/2, 424 ± 41 ms1/2, and 483 ± 54 ms1/2, respectively. VT occurred in only 1 patient (0.6%). Although PAP induced QTc prolongation (P < 0.05), the PAP-QTc duration was significantly shorter in NIC-PAP compared to PAP-NIC (P < 0.05).The administration of PAP with NIC may induce sufficient hyperemia and prevent fatal arrhythmia through reductions in the PAP-induced QTc prolongation during FFR measurement.

Pregnancy outcomes following gestational exposure to papaverine: An observational comparative study.

AIMS: Papaverine is indicated for abdominal pain of various aetiologies. However, data on maternal and foetal safety following gestational exposure are lacking. The aim was to examine whether first trimester exposure to papaverine is associated with increased risk for major malformation and whether gestational exposure at any stage is associated with increased risk for preterm delivery, lower birthweight, small for gestational age, caesarean section (CS), lower Apgar score and perinatal death. METHODS: A retrospective comparative study consisted of pregnant women treated with papaverine between February 2010 and October 2019 at a large tertiary center. The control group comprised of livebirth deliveries randomly selected from the institutional obstetric database. RESULTS: The study group consisted of 498 pregnancies, which resulted in 537/544 (98.7%) live births, of whom 46/537 (8.6%) were exposed during the first trimester. The control group consisted of 498 pregnancies and 514 live births. Rate of major malformations did not differ between study group (2/46, 4.3%) and control (25/315, 4.9%, P = .67). Papaverine exposure was associated with higher rate of preterm delivery (22.3 vs. 10.3%, P < .001), CS (35.9 vs. 24.1%, P < .001) and lower birth weight (3207 vs. 3246 g, P = .02). Adjustment for treatment indication demonstrated that these remained significant only when given for obstetrical/surgical aetiologies. Comparable rates were observed for the remaining outcomes. CONCLUSIONS: Short-term gestational exposure to papaverine adjusted for indication was not associated with preterm deliveries, CS, lower birthweight, small for gestational age or perinatal death. Rate of major malformations among 46 first trimester exposures was comparable to controls.

Independent Predictive Factors for Occurrence of Ischemic Priapism after Papaverine Injection.

PURPOSE: To analyze the predictive factors causing ischemic priapism following penile doppler ultrasonography (PDU) with intracavernosal papaverine injection   Materials and methods: Medical records of 467 patients who underwent PDU examination following intracavernosal papaverine injection for erectile dysfunction (ED) between 2009 and 2017 were retrospectively reviewed. Patients with hematological disease anamnesis, patients taking phosphodiesterase-5 inhibitor, patients with intracavernosal injection therapy anamnesis and patients who underwent PDU with other intracavernosal vasodilator drugs other than papaverine were excluded from the study. The remaining 268 patients were divided into two groups as priapism (38 patients) and non-priapism (230 patients). The groups were compared in terms of demographic data, American Society of Anesthesiologists (ASA) score, comorbidities, international index of erectile dysfunction (IIEF) score and PDU results. The significant parameters were analyzed with binary logistic regression analysis. The receiver operating analysis was used to obtain cut-off, sensitivity and specificity values for the independent predictive factors.    Results: The age, ASA score, diabetes mellitus, IIEF score, duration of ED, peak arterial and peak end diastolic venous flow values in the 20th minute were significantly different in the two groups (p<0.001). Binary logistic regression analysis found age, duration of erectile dysfunction, IIEF score, peak arterial flow and venous flow rate in the 20th minute were predictive variables for the occurrence of priapism.   Conclusions: Young patients, patients with good IIEF score, patients with ED for a short time, and patients with normal peak arterial and venous flows are more prone to developing post-papaverine ischemic priapism.

Confirmation of maximal hyperemia by the incremental dose of intracoronary papaverine.

We investigated the effect of the papaverine dose increment method to confirm maximal hyperemia for fractional flow reserve (FFR) measurements. We evaluated 115 consecutive patients involving 200 lesions. FFR was measured after intracoronary papaverine injection into the left (12 mg) and right (8 mg) coronary arteries as standard doses. Except for 2 patients who had ventricular tachyarrythmia (VTA), we administered a higher papaverine dose (2 mg added to the standard dose). We compared the FFR values after using different papaverine doses. VTA incidence and electrocardiogram parameters were compared according to the papaverine doses used. The QTU interval and corrected QTU were significantly prolonged after using a higher dose compared with a standard dose. VTA occurred in one patient (0.9%) at the higher dose. There was no significant difference with a strong correlation between the FFR values in the 2 doses (r = 0.963, P < 0.001). Maximal hyperemia was achieved in most patients at the standard papaverine dose. However, 19 lesions changed ischemic diagnosis at the higher dose (12 lesions changed from ischemia negative to positive, and 7 lesions changed from positive to negative). Therefore, to confirm the appropriate ischemia diagnosis for borderline FFR values, it may be favorable to perform another FFR measurement at an incremental papaverine dose.

Superior mesenteric artery syndrome coexists with Nutcracker syndrome in a female: a case report.

BACKGROUND: Superior mesenteric artery (SMA) syndrome, also known as Wilkie's syndrome or Benign duodenal stasis, is a rare benign disease. It could threaten the life if the manifestation is severe and the treatment is inappropriate. In the patients with SMA syndrome, the third portion (transverse part) of the duodenum is compressed externally between the SMA and abdominal aorta (AA) leading to duodenal stasis and gastrointestinal obstruction. SMA syndrome may rarely combine with Nutcracker syndrome when left renal vein (LRV) was compressed between SMA and AA. CASE PRESENTATION: A 32-year-old female patient presented with complaints of gradually severe bloating, epigastric pain, left flank ache, nausea and occasional vomiting of 1 month's duration. The epigastric and left flank ache was aggravated when the patient was supine and relieved in a prone or left lateral decubitus. The abdominal bloating was associated with early satiety. The vomiting always started 40 min after meal. The patient gave a history of urine stone with drotaverine hydrochloride tablets treatment for two weeks before the gastrointestinal symptoms arising. The patient had no significant surgical history, but had a rapid weight loss of approximately 10 kg with a body mass index (BMI) from 21 kg/m2 to less than 18 kg/m2 over the last two months. An abdominal examination revealed upper abdominal tenderness and distention. The urine routine examination showed no significant abnormality. The findings of initial blood tests and other laboratory investigations were unremarkable. CONCLUSIONS: This case reports a female patient with SMA syndrome with Nutcracker syndrome predisposed by Antispasmodics. We highlight the importance of the combination therapy of long-term nutritional supporting and prokinetic agents. Rehabilitating practice after discharge is beneficial to reduce recurrence.

Vasodilatory efficacy and impact of papaverine on endothelium in radial artery predilatation for cabg surgery: in search for optimal concentration

Abstract Objective: The aim of this study was to compare the efficacy of two different papaverine concentrations (0.5 mg/ml and 2 mg/ml) for vasospasm prevention and their impact on endothelium integrity. Methods: We have studied distal segments of radial arteries obtained by no-touch technique from coronary artery bypass graft (CABG) patients (n=10). The vasodilatory effect of papaverine (concentrations of 0.5 mg/ml and 2 mg/ml) was assessed in vitro, in isometric tension studies using ex vivo myography (organ bath technique) and arterial rings precontracted with potassium chloride (KCl) and phenylephrine. The impact of papaverine on endothelial integrity was studied by measurement of the percentage of vessel's circumference revealing CD34 endothelial marker. Results: 2 mg/ml papaverine concentration showed stronger vasodilatatory effect than 0.5 mg/ml, but it caused significantly higher endothelial damage. Response to KCl was 7.35±3.33 mN for vessels protected with papaverine 0.5 mg/ml and 2.66±1.96 mN when papaverine in concentration of 2 mg/ml was used. The histological examination revealed a significant difference in the presence of undamaged endothelium between vessels incubated in papaverine 0.5 mg/ml (72.86±9.3%) and 2 mg/ml (50.23±13.42%), P=0.002. Conclusion: Papaverine 2 mg/ml caused the higher endothelial damage. Concentration of 0.5 mg/ml caused better preservation of the endothelial lining.

Efficacy and safety of fixed-dose combination of drotaverine hydrochloride (80 mg) and paracetamol (500 mg) in amelioration of abdominal pain in acute infectious gastroenteritis: A randomized controlled trial.

BACKGROUND AND AIM: This randomized controlled trial was undertaken to assess efficacy and safety of fixed-dose combination of drotaverine hydrochloride (80 mg) and paracetamol (PCM) (500 mg). This was performed by comparison of mean pain intensity difference, total pain relief at 2 h, onset of pain relief, decrease in number of pain episodes, global improvement, and adverse effects. METHODS: A randomized double-blind controlled trial for adults between 18 and 59 years of either gender with acute infectious diarrhea (≥ 3 unformed, watery, or soft stools with symptoms at least within the last 24 h preceding randomization with duration of illness not more than 72 h) with moderate-to-severe abdominal pain. Participants were treated with either a fixed-dose combination of oral drotaverine hydrochloride (80 mg) and PCM (500 mg) or oral PCM (500 mg) three times a day for 3 days. RESULTS: Of 252 (126 in each group) participants, all received at least one dose of medication. Two hundred forty-two completed the study. Mean pain intensity difference at 60 min after administration of study medication by Visual Analogue Scale (VAS) and total pain relief at 2 h using both VAS and Verbal Rating Scale showed statistically significant improvement in drotaverine hydrochloride (80 mg) and PCM (500 mg) group. The onset of pain relief was also significantly better in drotaverine hydrochloride (80 mg) and PCM (500 mg) group when using VAS. CONCLUSION: Fixed-dose combination of drotaverine hydrochloride (80 mg) and PCM (500 mg) is an effective and safe antispasmodic agent in abdominal pain associated with acute infectious gastroenteritis.

Neuromuscular electrical stimulation as an adjunctive therapy to drotaverine hydrochloride for treating patients with diarrhea-predominant irritable bowel syndrome: A retrospective study.

This retrospective study investigated the effectiveness and safety of neuromuscular electrical stimulation (NMES) as an adjunctive therapy to drotaverine hydrochloride (DHC) in patients with diarrhea-predominant irritable bowel syndrome (BP-IBS).A total of 108 patient cases with BP-IBS were included in this study. Of these, 54 cases were assigned to a treatment group and received NMES and DHC, whereas the other 54 subjects were assigned to a control group and underwent DHC alone. All patients were treated for a total of 4 weeks. Primary outcomes were measured by the visual analog scale (VAS), and average weekly stool frequency. Secondary outcome was measured by the Bristol scale. In addition, adverse events were documented. All outcome measurements were analyzed before and after 4-week treatment.Patients in the treatment group did not show better effectiveness in VAS (P = .14), and average weekly stool frequency (P = .42), as well as the Bristol scale (P = .71), compared with the patients in the control group. Moreover, no significant differences in adverse events were found between 2 groups.The results of this study showed that NMES as an adjunctive therapy to DHC may be not efficacious for patients with BP-IBS after 4-week treatment.

Evaluation of the risk factors for ventricular arrhythmias secondary to QT prolongation induced by papaverine injection during coronary flow reserve studies using a 4 Fr angio-catheter.

Estimation of the fractional flow reserve (FFR) is considered to be an established method by which to assess stable coronary artery stenosis. Induction of maximal coronary hyperemia is important during the FFR procedure. Papaverine has been reported to increase the risk of ventricular arrhythmia (VA). The purpose of the present study was to discover predictors of papaverine-induced VAs developing during FFR measurement. A total of 213 clinically stable patients were included in the study. FFRs were determined after intracoronary papaverine administration (12 mg into the left and 8 mg into the right coronary arteries). We compared patients in whom VA did and did not develop in terms of clinical and electrocardiogram characteristics. FFR measurements were performed on 244 lesions (133 in the left anterior descending arteries, 43 in the left circumflex arteries, and 68 in the right coronary arteries). We found that the QTc interval was prolonged in all patients after papaverine administration (average post-administration QTc interval = 569 ± 89 ms; average ΔQTc interval = 144 ± 80 ms). VA developed in three patients with significantly prolonged QT intervals (average post-administration QTc interval = 639 ± 19 ms, average ΔQTc interval = 220 ± 64 ms, p < 0.02) and transitioned from torsade de pointes to ventricular fibrillation. Bradycardia (< 50 beats/min), hypokalemia (serum K < 3.5 mEp/L), and low left ventricular function (ejection fraction (EF) < 50%) were associated with VA (bradycardia, p < 0.01; hypokalemia, p < 0.01; low left ventricular function, p < 0.01). Three-vessel disease was significantly predictive of VA (p < 0.003). In the three-vessel group, the complications of low left ventricular function, hypokalemia, and bradycardia were significantly associated with VA (p < 0.045). Three-vessel disease is a predictor of the development of VA during FFR measurement performed with the aid of papaverine, especially if accompanied by one or more of the following: low left ventricular function, hypokalemia, or bradycardia.

Sinus Standstill in a Patient after Intracoronary Papaverine Administration for a Coronary Fractional Flow Reserve.

A 78-year-old woman had paroxysmal atrial fibrillation and effort angina. Two months before she was admitted for a coronary angiography, she had been feeling dizzy. A Holter 24-hour electrocardiography monitor exhibited an asymptomatic episode of 2.9 seconds of RR interval. She underwent a coronary angiography, which showed intermediate stenosis in the left descending artery. Fractional flow reserve (FFR) measurement using intracoronary papaverine administration was performed. After intracoronary papaverine (12 mg) administration, pause of 4 seconds led to polymorphic ventricular tachycardia (VT), although the VT terminated spontaneously. Premature ventricular beat occurred and led to sustained polymorphic VT. In cardiac electrophysiology study, pacing from the right atrium showed that the maximum sinus node recovery time (SRT) was 910 ms. After procainamide (10 mg/kg) administration, the maximum SRT was 16.3 seconds with some junctional escapes. After intravenous papaverine administration, there was a slight change. Intracoronary papaverine administration induced about 9-seconds pause with some junctional escapes. We conclude that intracoronary papaverine administration reveals potential sinus node dysfunction. The patient has been asymptomatic since the implantation of the pacemaker. Patients with suspicious sinus dysfunction should be careful.

Prolonged Intracisternal Papaverine Toxicity: Index Case Description and Proposed Mechanism of Action.

BACKGROUND: Intracisternal papaverine (iPPV) is a vasodilator used for prophylaxis of intraoperative vasospasm during aneurysmal clipping. Postoperative side effects of iPPV include transient cranial nerve palsies, most commonly mydriasis owing to oculomotor nerve involvement, with rapid resolution. METHODS: We critically reviewed current literature on the adverse effects of iPPV in aneurysmal surgery with a focus on oculomotor nerve involvement. We also present the index case of prolonged bilateral mydriasis secondary to iPPV irrigation toxicity and its putative underlying mechanism. RESULTS: Papaverine toxicity occurs in the setting of its antimuscarinic action and blood-cerebrospinal fluid and blood-brain barrier compromise owing to acute subarachnoid hemorrhage and direct effect of papaverine. Our patient also experienced severe vasospasm and a minor stroke, both contributing to further blood-brain barrier disruption, and relatively acidic pH of the subarachnoid hemorrhage milieu. CONCLUSIONS: We propose that these factors perpetuate phase dynamics of papaverine crystals and facilitate a sustained slow release of papaverine within the cisternal system. Were it indicated, 0.3% iPPV would reasonably diminish the risk for neurotoxicity.

Vasodilatory Efficacy and Impact of Papaverine on Endothelium in Radial Artery Predilatation for CABG Surgery: in Search for Optimal Concentration.

OBJECTIVE: The aim of this study was to compare the efficacy of two different papaverine concentrations (0.5 mg/ml and 2 mg/ml) for vasospasm prevention and their impact on endothelium integrity. METHODS: We have studied distal segments of radial arteries obtained by no-touch technique from coronary artery bypass graft (CABG) patients (n=10). The vasodilatory effect of papaverine (concentrations of 0.5 mg/ml and 2 mg/ml) was assessed in vitro, in isometric tension studies using ex vivo myography (organ bath technique) and arterial rings precontracted with potassium chloride (KCl) and phenylephrine. The impact of papaverine on endothelial integrity was studied by measurement of the percentage of vessel's circumference revealing CD34 endothelial marker. RESULTS: 2 mg/ml papaverine concentration showed stronger vasodilatatory effect than 0.5 mg/ml, but it caused significantly higher endothelial damage. Response to KCl was 7.35±3.33 mN for vessels protected with papaverine 0.5 mg/ml and 2.66±1.96 mN when papaverine in concentration of 2 mg/ml was used. The histological examination revealed a significant difference in the presence of undamaged endothelium between vessels incubated in papaverine 0.5 mg/ml (72.86±9.3%) and 2 mg/ml (50.23±13.42%), P=0.002. CONCLUSION: Papaverine 2 mg/ml caused the higher endothelial damage. Concentration of 0.5 mg/ml caused better preservation of the endothelial lining.

Etiological factors and management in priapism patients and attitude of emergency physicians.

OBJECTIVE: To present the underlying etiological factors in patients referring with priapism, sharing how they are managed according to etiology and priapism type together with our experiences, creating awareness so that urologists and emergency physicians may play a more active role together in priapism management. MATERIALS AND METHODS: Patients referring to emergency service with priapism were examined. Penile Doppler ultrasonography (PDU) and/or corporeal aspiration and blood gas analysis were made in order to determine priapism type after anamnesis and physical examination. The most appropriate treatment option was chosen and applied on the patients considering priapism type, underlying etiological factors and priapism time. Presence of a statistical difference between etiological factors causing priapism, priapism type and applied treatment methods was calculated using Chi square (χ2) test. RESULTS: A total of 51 patients referring to emergency service with priapism attacks for 53 times were included in the evaluation. When compared to other etiological factors, number of priapism cases developing secondary to papaverine after PDU was found statistically significantly high (p < 0.001). Ischemic priapism ratio was detected statistically higher compared to other groups (p < 0.001). Aspiration and/or irrigation treatment were the most common method used for treatment at a statistically significant level (p < 0.001). All patients (100%) were hospitalized in urology service without applying any treatment in emergency service and had treatment and intervention under the control of the urologist. CONCLUSIONS: Application of non-invasive treatments in suitable priapism patients would protect patients from invasive painful interventions. We believe that emergency physicians should be more effective in priapism phase management and at least noninvasive treatment phase.

Papaverine-induced polymorphic ventricular tachycardia during coronary flow reserve study of patients with moderate coronary artery disease.

BACKGROUND: Papaverine is useful for evaluating the functional status of a coronary artery, but it may provoke malignant ventricular arrhythmia (VA). The aim of this study was to investigate the incidence, and clinical and ECG characteristics of patients with papaverine-induced VAs. METHODS AND RESULTS: The 182 consecutive patients underwent fractional flow reserve (FFR) measurement of 277 lesions. FFR was determined after intracoronary papaverine administration by standard procedures. The clinical and ECG characteristics were compared between patients with and without ventricular tachycardia (VT: ≥3 successive premature ventricular beats (PVBs), or ventricular fibrillation (VF)). After papaverine administration, the QTc interval, QTUc interval, and T-peak to U-end interval were prolonged significantly. Single PVBs on the T-wave or U-wave type developed in 29 patients (15.9%). Polymorphic VT (torsade de pointes) occurred in 5 patients (2.8%), and of those, VF developed in 3 patients (1.7%). No clinical and baseline ECG parameters were predictors for VT or VF except for sex and administration of papaverine into the left coronary artery. Excessive prolongation of QT (or QTU), T-peak to U-end intervals and giant T-U waves were found immediately prior to the ventricular tachyarrhythmias (VTAs), which were unpredictable from the baseline data. CONCLUSIONS: Intracoronary administration of papaverine induced fatal VTAs, although the incidence is rare. Excessive prolongation of the QT (and QTU) interval appeared prior to VTAs; however, they were unpredictable.

Transient pupillary dilation following local papaverine application in intracranial aneurysm surgery.

Isolated cases of transient pupillary changes after local intracisternal papaverine administration during aneurysm surgery have been reported. This study aimed to determine the prevalence and factors associated with this phenomenon. We assessed a total of 103 consecutive patients who underwent craniotomy for cerebral aneurysm clipping for the presence of postoperative pupillary dilation (mydriasis) after intracisternal papaverine administration. Univariate and multivariate logistic regression were conducted to evaluate the association of mydriasis with patient age, sex, duration of surgery, and aneurysm location. We observed either ipsilateral or bilateral pupillary dilation in the immediate postoperative period in nine out of 103 patients (8.7%). This phenomenon was not associated with patient age or sex. There was a trend towards positive correlation with aneurysms located at the anterior communicating artery (odds ratio 3.76, p=0.10), and a negative correlation with the duration of surgery (odds ratio 0.57, p=0.08). All pupillary dilation resolved within several hours, and the onset and resolution were consistent with the half-life of papaverine. To our knowledge, this represents the largest study of posteropative pupillary changes due to papaverine. The current findings are consistent with the small number of prior case reports of transient pupillary changes after papaverine administration and appear to reflect the local anesthetic action of papaverine on the oculomotor nerve.

Papaverine-induced QT interval prolongation and ventricular fibrillation in a patient with a history of drug-induced QT prolongation.

A 64-year-old woman underwent a coronary flow reserve evaluation using intracoronary-administered papaverine into the left anterior descending artery. Her baseline electrocardiogram (ECG) was normal, but toward the end of papaverine administration, the QTU intervals were excessively prolonged and torsade de pointes occurred, leading to ventricular fibrillation. Ten months previously, the patient's ECG showed mildly prolonged QTc (480 ms(1/2)), which normalized after the cessation of bepridil. This case report suggests that a history of drug-induced QT prolongation can be a risk factor for papaverine-induced fatal ventricular arrhythmia.

Clinical efficacy of Spasmofen® suppository in the emergency treatment of renal colic: a randomized, double-blind, double-dummy comparative trial.

BACKGROUND: Renal colic is typically characterized by the sudden onset of severe pain radiating from the flank to the groin and its acute management in emergency departments essentially aims at rapid pain relief. Spasmofen(®) is a brand of Amriya Pharmaceutical Industries in the form of rectal suppositories containing ketoprofen 100 mg and hyoscine butylbromide 10 mg. This combination is intended for the rapid relief of severe colicky pain in the renal system, hepatobiliary system, or gastrointestinal tract. This trial aims to compare a single-dose of Spasmofen rectal suppository to a single intravenous (IV) ketorolac tromethamine 30 mg/2 mL dose in patients with acute renal colic. METHODS: A total of 80 eligible consecutive patients presenting to the emergency departments of two medical centers with acute renal colic were included in the study. Eligible patients who signed the informed consent were randomly assigned into two treatment groups: an experimental group (Spasmofen group) who received one Spasmofen rectal suppository plus an IV injection of 2 mL of normal saline solution; and a control group (ketorolac group) who received one ketorolac 30 mg/2 mL ampoule IV plus one placebo suppository. Treatment success, defined as a change in the verbal rating score from severe or moderate pain to none or mild at 60 minutes after the dose, was compared between groups using the chi-square/Fisher's exact test. Percentage reductions in visual pain analog scale (VPAS) scores at 15 and 60 minutes after the dose were compared between groups using the Z-test for proportions. RESULTS: Successful treatment at 60 minutes occurred in 35 of 40 (87.5%) of Spasmofen-treated patients and in 33 of 40 (82.5%) of ketorolac-treated patients. The difference was not statistically significant by Fisher's exact test (P=0.755). The mean percentage reduction of VPAS after 15 minutes was 61.82% in the Spasmofen-treated group and 64.76% in the ketorolac-treated group. The difference was also not statistically significant by the Z-test for proportions (P=0.795). Sixty minutes after being treated, Spasmofen was associated with a statistically significant greater reduction in VPAS (mean% reduction =92.36%) than ketorolac (75.06%; P=0.0466). CONCLUSION: Single-dose Spasmofen rectal suppository might be a safe and effective first-aid treatment for the emergency department relief of acute renal colic.

Drotaverine to improve progression of labor among nulliparous women.

OBJECTIVE: To reevaluate the role of the antispasmodic drug drotaverine in shortening the length of the active first stage of labor among nulliparous women. METHODS: In a randomized, double-blind, placebo-controlled trial, 422 young nulliparous women admitted to Ain-shams University Maternity Hospital, Cairo, Egypt, in spontaneous labor were initially enrolled between May and December 2012. Drotaverine hydrochloride (40mg) or placebo was given at the start of the active phase of labor and then repeated every 2hours (maximum 3 doses). All participants were consistently managed in accordance with the local institutional intrapartum protocol. The primary outcome was the rate of cervical dilation. RESULTS: After excluding women who delivered by cesarean, data were analyzed from 320 women. There was a significant difference in post-treatment labor pain scores, duration of the active phase of labor, and rate of cervical dilatation between the 2 groups (P<0.001 for all). There was no difference in maternal adverse effects. Kaplan-Meier survival analysis showed a greater probability of faster delivery among patients treated by drotaverine hydrochloride (log rank test; P<0.001). CONCLUSION: Drotaverine hydrochloride was used effectively and safely to shorten the duration of the first stage of labor among nulliparous women with active spontaneous labor. ClinicalTrials.gov: NCT01639027.