Randomised trial of IV metoclopramide vs IV ketorolac in treatment of acute primary headaches.

INTRODUCTION: Headache is one of the most common neurological conditions among emergency department visits (ED), although the best therapy has not been identified yet. Therefore, in the current study, we aimed to compare the pain-relieving effect of metoclopramide and ketorolac in acute primary headaches patients. METHODS: This double-blind, randomised clinical trial was conducted at Golestan Hospital, Ahvaz, Iran. This research involved all adult patients with acute primary (migraine or tension-type) headaches presented to the ED. Pain intensity was assessed with 0 to 10 verbal Numeric Rating Scales (NRS). The subjects were randomised into 10 mg intravenous (IV) metoclopramide or 30 mg IV ketorolac groups. Pain score and drug adverse reactions were compared between the two groups at baseline, 15, 30, and 60 min after baseline. RESULTS: 108 patients completed this trial and were equally divided into two groups (mean age of 34 ± 8.54 years; 57.4% female). Before treatment, the mean pain score was 6.9 and 6.8 in metoclopramide and ketorolac groups, respectively (p > 0.05). Metoclopramide failed to provide more improvement in pain score at 30 min (p = 0.55) and 60 min (p = 0.15) from baseline. There were no serious adverse events in this study. Only five patients required rescue medication which four of them were in ketorolac group. CONCLUSION: We were unable to reject the null hypothesis that there would be no difference in pain outcomes between metoclopramide and ketorolac.

Identifying medication errors in neonatal intensive care units: a two-center study.

BACKGROUND: This study aimed to assess the types and frequency of medication errors in our NICUs (neonatal intensive care units). METHODS: This descriptive cross-sectional study was conducted on two neonatal intensive care units of two hospitals over 3 months. Demographic information, drug information and total number of prescriptions for each neonate were extracted from medical records and assessed. RESULTS: A total of 688 prescriptions for 44 types of drugs were checked for the assessment of medical records of 155 neonates. There were 509 medication errors, averaging (SD) 3.38 (+/- 5.49) errors per patient. Collectively, 116 neonates (74.8%) experienced at least one medication error. Term neonates and preterm neonates experienced 125 and 384 medication errors, respectively. The most frequent medication errors were wrong dosage by physicians in prescription phase [WU1] (142 errors; 28%) and not administering medication by nurse in administration phase (146 errors; 29%). Of total 688 prescriptions, 127 errors were recorded. In this regard, lack of time and/or date of order were the most common errors. CONCLUSIONS: The most frequent medication errors were wrong dosage and not administering the medication to patient, and on the quality of prescribing, lack of time and/or date of order was the most frequent one. Medication errors happened more frequently in preterm neonates (P < 0.001). We think that using computerized physician order entry (CPOE) system and increasing the nurse-to-patient ratio can reduce the possibility of medication errors.

Pattern and extent of off-label and unlicensed drug use in neonatal intensive care units in Iran.

BACKGROUND: Many newborns may need to be hospitalized and receive drugs during the first days of their lives. These drugs are fundamentally prescribed as off-label and unlicensed. This study aimed to investigate the amount of these kinds of drugs administered in the Neonatal Intensive Care Units (NICUs) of Abuzar and Imam Khomeini Teaching Hospitals in Ahvaz, Iran. METHODS: This was a 3-month descriptive, cross-sectional study with retrospective nature in which 193 hospitalized newborns were studied. Demographic data were extracted from the patients' files. The drugs were classified as off-label, unlicensed or licensed according to the Pediatric & Neonatal Dosage Handbook (Lexicomp®, 22nd Edition). RESULTS: In total, 1049 prescriptions were registered for the 193 hospitalized newborns (term and preterm). For each newborn, the mean numbers of prescriptions and drugs received were 5.4 and 4.5, respectively. The mean numbers of prescriptions and drugs were greater for preterm newborns. Of the total 1049 prescriptions, 38.1% were off-label and 1.9% were unlicensed. Of the 193 newborns, 85% received at least one off-label or unlicensed prescription. Off-label prescriptions were mostly related to dose (44.8%) and dosing interval (36.5%). Most off-label drugs were antibiotics (mainly Gentamicin). Albuterol was used off-label in 100% of the cases. CONCLUSIONS: The results of the present study show that the prescription of off-label and unlicensed drugs in NICUs is as high in Iran as in other countries. This suggests that it is necessary to provide information to neonatologists to decrease the prescription of off-label and unlicensed drugs.

Memantine Augmentation Improves Symptoms in Serotonin Reuptake Inhibitor-Refractory Obsessive-Compulsive Disorder: A Randomized Controlled Trial.

INTRODUCTION: There is a large body of evidence on the clinical benefits of augmentation therapy with glutamate-modulating agents, such as memantine in reducing OCD symptoms. METHODS: A double-blind, placebo-controlled trial was conducted on SRIrefractory OCD patients. Thirty-two patients were randomized to receive either 20 mg/day memantine or placebo augmentation and were visited at baseline and every 4 weeks for 12 weeks. Results were measured using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). RESULTS: The Y-BOCS total score was significantly reduced in the memantine group at the end of weeks 8 and 12, while no improvement was observed in the placebo group throughout the trial. A reduction of 40.9% in the mean Y-BOCS total score by week 12 in the memantine group resulted in 73.3% of patients achieving treatment response. The findings showed that a time to effect of 8 weeks was necessary to observe significant improvement in OCD symptoms, while treatment response was only seen after 12 weeks of memantine augmentation. DISCUSSION: Memantine is an effective and well-tolerated augmentation in severe OCD patients refractory to SRI monotherapy.

Drug Interaction and Serotonin Toxicity with Opioid Use: Another Reason to Avoid Opioids in Headache and Migraine Treatment.

Treatment of headache, specifically migraine attacks, has always been a challenging subject, especially for neurologist and pain specialists. Triptans are generally underutilized, despite being the gold standard abortive medication for migraine attacks. On the other hand, opioid analgesics are overused as a treatment for headache. One reason for this could be physician unfamiliarity with drug interactions between opioids and other medications, especially the possibility of serotonin toxicity. The general awareness of potential serotonin toxicity with using opioid analgesics is low. In this review, we will conduct a theoretic and evidence-based review of the potential for developing serotonin syndrome in patients who are using opioids analgesics, especially in combination with antidepressants, a common co-prescribed combination. We also review the current diagnostic criteria for serotonin syndrome and identify possible shortcomings of those criteria. Our aim is to increase the awareness of health care providers about potential drug interaction of opioid analgesics with other classes of medication. We place particular emphasis on tramadol since this drug is one of the most commonly used opioid analgesics for headache. The potential for developing serotonin syndrome is relatively high in the patients who are using opioid for pain control. The use of opioids in migraine headache is already discouraged due to the high risk of medication overuse headache and also an increase in headache-related disability (Katsarava et al. Neurology 62:788-790, 2004; Bigal and Lipton. Neurology 71:1821-8, 2008; Casucci and Cevoli. Neurol Sci. 34 Suppl 1:S125-8, 2013). This is another reason that physicians and health care providers should avoid using this class of medication for pain, specifically headache and migraine treatment.

The Effect of Melatonin on Reducing the Frequency and Severity of Migraine Attacks: A Double-Blind, Randomized Clinical Trial.

Background: There is no definite recommendation for melatonin supplementation in episodic migraine. This study aimed to evaluate the effect of melatonin on reducing the frequency and severity of migraine attacks. Methods: This randomized, double-blind clinical trial was conducted at Golestan Hospital of Ahvaz, Iran, in 2021. A total of 60 patients with episodic migraine were randomly assigned into 2 groups of receiving 3 mg melatonin (intervention group; n=30) or the same dose of placebo (control group; n=30) along with baseline therapy (propranolol 20 mg, BID) for two months. The attack frequency, attack duration, attack severity (based on VAS), the number of analgesic intakes, drug complications, Migraine Disability Assessment score (MIDAS), and Pittsburgh sleep quality index (PSQI) were evaluated at baseline and in the first, second, third, and fourth months of follow-up. The independent t test, chi-square, and analysis of variance (ANOVA) with repeated measures were used to compare variables between the two groups. Results: In both groups, the frequency, duration, and severity of attacks, taking analgesics, MIDAS, and PSQI scores during follow-up decreased significantly (P<0.001). After treatment, the mean frequency (P=0.032) and duration of attacks (P=0.001), taking analgesic (P<0.001), and MIDAS (P<0.001) and PSQI scores (P<0.001) in the melatonin group were lower than placebo. Only the attack severity was not significantly different between the two groups (P=0.126). Side effects were observed in two patients (6.7%) in the melatonin group and one patient (3.3%) in the placebo group (P>0.999). Conclusion: Our study shows that melatonin was more efficacious than the placebo in the reduction of frequency and duration of migraine attacks. It was equally safe as the placebo and might be effective in the preventive treatment of episodic migraine in adults.Trial Registration Number: IRCT20190107042264N5.

Solifenacin versus posterior tibial nerve stimulation for overactive bladder in patients with multiple sclerosis.

Introduction: Overactive bladder (OAB) is one of the most common complications in patients with multiple sclerosis (MS). Choosing the effective treatment is very important in improving their quality of life (QOL). Therefore, the aim of this study was to compare solifenacin (SS) and posterior tibial nerve stimulation (PTNS) treatment effects in the MS Patients with OAB. Materials and methods: In total, 70 MS patients suffering from OAB enrolled in this clinical trial study. Patients with a score of at least 3 according to the OAB questionnaire were randomly divided into two groups (35 patients in each group). In one group, patients received SS (5 mg daily for 4 weeks and 10 mg/day for another 8 weeks) and in a second group, patients were treated by PTNS (12 weekly session, 30 min). Results: The mean (SD) age of patients participating in this study was 39.82 (9.088) and 42.41 (9.175) years for the SS group and the PTNS group, respectively. Patients in both groups showed statistically significant improvements in urinary incontinence, micturition, and daytime frequency (p < 0.001). Patients in the SS group had a better response for urinary incontinence after 12 weeks compared to the PTNS group. Also, patients in the SS group reported higher satisfaction and less daytime frequency compared to the PTNS group. Conclusion: SS and PTNS were effective for improving the OAB symptoms in patients with MS. However, patients demonstrated a better experience with SS in terms of daytime frequency, urinary incontinence, and treatment satisfaction rate.

Positive effect of septimeb™ on mortality rate in severe sepsis: a novel non antibiotic strategy.

BACKGROUND: Septimeb is a new herbal-derived remedy, recently approved for its potential immunomodulatory effects. Regarding the key role of immune system in the pathogenesis of severe sepsis and lack of any standard treatment for improving survival of these patients; we evaluated the effect of Septimeb -as an adjutant to standard treatment-on inflammatory biomarkers and mortality rates in patients with severe sepsis. METHODS: In this multicenter, randomized, single-blind trial, we assigned patients with severe sepsis and Acute Physiology and Chronic Health Evaluation (APACHE II) score of more than 20 to receive standard treatment of severe sepsis (control group) or standard treatment plus Septimeb. This group was treated with Septimeb for 14 days then followed up for another14 days. APACHE score, Sequential Organ Failure Assessment (SOFA) and Simplified Acute Physiology Score (SAPS) were calculated daily. Blood samples were analyzed for interleukin 2 tumor necrosis factor-α, total antioxidant power, platelet growth factor and matrix metalloproteinase 2. RESULTS: A total of 29 patients underwent randomization (13 in control group and 16 in Septimeb group). There was significant difference between the Septimeb and control group in the 14 days mortality rate (18.8% vs. 53.85 respectively, P=0.048). Compared to control group, Septimeb was significantly effective in improving SAPS (P= 0.029), SOFA (P=0.003) and APACHE II (P=0.008) scores. Inflammatory biomarkers didn't change significantly between the two groups (P>0.05). CONCLUSION: Septimeb reduces mortality rates among patients with severe sepsis and it could be added as a safe adjutant to standard treatment of sepsis.

Validity and reliability of the Persian version of the Montreal Cognitive Assessment (MoCA-P) scale among subjects with Parkinson's disease.

Parkinson's disease (PD) is a progressive multifactorial degenerative disorder that has both motor and nonmotor features. Among the nonmotor features of PD, cognitive impairment; Mild Cognitive Impairment (MCI) and dementia, poses one of the most significant implications for disability. Because of the high possibility of developing Dementia in PD, it is essential to obtain a reliable cognitive screen. Two commonly used cognitive measures include the Mini Mental Status Examination (MMSE) and the Montreal Cognitive Assessment (MoCA). The MoCA is a more sensitive tool for the detection of MCI in compared to the MMSE. Because of the cultural differences, in this study, we evaluated the psychometric properties of the Persian version of the MoCA (MoCA-P) in a group of participants with PD in Iran. Participants were assessed by MMSE, Geriatric Depression Scale (GDS), and Functional Assessment Staging Test (FAST). If they met study eligibility, the MoCA-P scale was administered. Receiver Operating Characteristic (ROC) curve analyses showed that the MoCA-P scale produced significant discrimination of PD with Dementia (PDD) from PD with MCI (PD-MCI). It seems that the MoCA-P has adequate psychometric properties as a screening instrument for the detection of PD-MCI and PDD in Iranian patients. As near to 30% of patients with PD go on to develop dementia, the MoCA-P can be useful in the detection of cognitive impairment in patients with PD and is suitable for executive function assessment.

Cognitive Function before and during Treatment with Selective Serotonin Reuptake Inhibitors in Patients with Depression or Obsessive-Compulsive Disorder.

Objectives. Identification of adverse effects of selective serotonin reuptake inhibitors (SSRIs) is of great importance due to their extensive use in medicine. Some studies have reported the effects of SSRIs on cognitive functions, but the results are conflicting. This study was designed to assess the effect of these drugs on cognition of patients with depression or obsessive-compulsive disorder (OCD). Methods. Patients with depression or OCD, naïve to therapy, and candidates of receiving one drug from SSRI class, voluntarily, entered this study. Mini-Mental State Examination (MMSE) test was the tool to assess their cognitive functions. MMSE scores of each patient were recorded prior to taking SSRIs and at weeks 3, 5, and 8 of drug therapy. Results. 50 patients met our inclusion criteria, with a baseline mean MMSE score of 23.94. At 3, 5, and 8 weeks of treatment, the mean scores were 22.1, 21.4, and 20.66, respectively. With a p value of <0.0001, the gradual decline was statistically significant. Conclusion. The MMSE scores of our patients showed a gradual decline over the consecutive weeks after taking SSRI drugs. It seems that the use of SSRIs in patients with depression or OCD, can cause cognitive dysfunction in the acute phase of treatment.

Changes of Nitric Oxide and Peroxynitrite Serum Levels during Drug Therapy in Patients with Obsessive-Compulsive Disorder.

Objectives. Some studies have shown that increased nitric oxide (NO) concentrations may be associated with obsessive-compulsive disorder (OCD). In a few animal researches, enhanced synthesis of NO had reversed the effect of selective serotonin reuptake inhibitors (SSRIs). The present study tries to find the effect of treatment with SSRIs on NO serum levels and its product peroxynitrite. Patients and Methods. Patients diagnosed with OCD who are candidates of receiving SSRIs entered this study. Two blood samples were taken from subjects, prior to drug therapy and after the patients had shown some improvements due to their regimen. Serum NO and peroxynitrite levels were measured and their correlation with SSRI use was assessed. Results. 31 patients completed this study. Mean concentrations of NO and peroxynitrite prior to drug therapy were 28.63 ± 16.9 and 5.73 ± 2.5 µmol/L, respectively. These values were 18.87 ± 7.55 and 2.15 ± 0.94 µmol/L at the second blood test. With p values < 0.05, these differences were considered significant. Conclusion. Patients, who showed improvement of OCD symptoms after a mean duration of SSRI monotherapy of 3.531 ± 0.64 months, had lower values of NO and peroxynitrite in their sera compared to their levels prior to therapy. Such results can be helpful in finding a predictive factor of response to therapy and augmentation therapy with future drugs that target NO synthesis.