Double-blind Randomized Clinical Trial Study Research Articles

Effect of herbal composition (Oak Gall, pomegranate peel and Fenugreek Seeds) on sexual satisfaction of women at reproductive age

Introduction: Satisfactory sexual relations promote women's health and quality of life. Some medicinal Plants can have an effect on sexual satisfaction due to the presence of certain compounds. This study was performed with aim to investigate the effect of herbal composition (Oak Gall, pomegranate peel and Fenugreek Seed) on female sexual satisfaction. Methods: This double-blind randomized clinical trial study was performed as parallel in 2020 on 60 women aged 15-45 years referred to Ardabil Comprehensive Health Centers. Subjects were divided into two groups of herbal vaginal suppositories (n=30) and placebo (n=30), and both groups used the suppository 2 days a week for 1 month. Data collection tools were Larson Questionnaire and Orgasm Questions (FSFI). Data were analyzed by SPSS software (version 23) and paired t-test, independent t-test, Chi-square and analysis of covariance. P<0.05 was considered statistically significant. Results: Before treatment, there was no significant difference between the two groups in terms of orgasm scores and level of sexual satisfaction (p <0.05). After treatment, orgasm scores were significantly higher in the group consuming herbal suppositories than the control group (p <0.001), but the two groups did not have a significant difference in terms of sexual satisfaction (p = 0.14). Conclusion: The use of herbal compounds (Oak Gall, pomegranate peel, Fenugreek Seeds) can improve orgasm. Further studies in this field are recommended to ensure the effect of this herbal compound on sexual satisfaction.

Effect of Dexmedetomedine in combination with intrathecal bupivacaine on the incidence of shivering after orthopedic surgery of the femur and tibia: a double-blind randomized clinical trial study

Effect of Dexmedetomedine in combination with intrathecal bupivacaine on the incidence of shivering after orthopedic surgery of the femur and tibia: a double-blind randomized clinical trial study

The efficacy of zinc augmentation in children with attention deficit hyperactivity disorder under treatment with methylphenidate: A randomized controlled trial.

Regarding to the role of the zinc in the metabolism of the central nervous system and the correlation of zinc supplementation in the treatment of any Attention deficit hyperactivity disorder (ADHD) symptoms, this study was conducted to evaluate the complementary effects of this nutrient. This was a double-blind randomized clinical trial study and 60 children with ADHD who were treated with methylphenidate were chosen by random allocation and were divided in the two groups: 30 for the case and 30 for the control group. The treatment in case group was augmented with zinc. Duration of study was six weeks. Forty eight (80%) of participants were boy and 12 (20%) were girl. The mean age of patients was 9.6 ± 1.70 years. There was no significant difference between the two groups after the intervention in terms of total score, hyperactivity and impulsivity subscales during variance analysis, but there was a significant difference between the mean of inattention score. Augmentation with zinc can enhance the improvement of inattention.

Effect of Cold Hemodialysis on Hemoglobin and Hematocrit in Hemodialysis Patients: A Crossover Clinical Trial Study

Background: One of the common complications of renal failure in hemodialysis patients which has a negative impact on quality of life is anemia. Various studies showed that cold hemodialysis could improve hemodialysis complications such as pruritus, sleep disorders and fatigue. Objectives: The aim of this study was determine the effect of cold hemodialysis on hemoglobin and hematocrit level in hemodialysis patients. Methods: This research was a double-blind crossover randomized clinical trial study. 42 hemodialysis patients were divided into two groups (22 in the first group and 20 in the second group). The first group received standard hemodialysis temperature (fluid 37°C) in the first four weeks and simultaneously the second group received cold hemodialysis (fluid 35°C), in the second phase, four weeks later, the type of hemodialysis was changed in two groups. During the study, hemoglobin and hematocrit levels of patients were measured several times. Results: The results showed that in the first and second groups respectively, 55 and 32 percent of patients were in the age range of 50 - 65 years. Hemoglobin and hematocrit levels before the study in the two groups was not statistically significant (P: 0.19). But after the first four weeks, the mean of hemoglobin in the cold and standard hemodialysis were 13.85 vs. 11.9 and hematocrit 43.83 vs. 38.02, respectively and after the second four weeks the average hemoglobin in the cold and standards hemodialysis were 13.57 vs. 11.47, respectively and hematocrit 43.29 vs. 37.18. Crossover outcomes of the groups’ analysis showed that cold hemodialysis significantly increased hemoglobin and hematocrit levels in hemodialysis patients (P < 0.001). Conclusions: The mean of hemoglobin and hematocrit was different between two groups and significantly higher in cold hemodialysis.

Stabilization exercise affects function of transverse abdominis and pelvic floor muscles in women with postpartum lumbo-pelvic pain: a double-blinded randomized clinical trial study.

Lumbo-pelvic pain (LPP) is a common disorder in women after pregnancy due to ligament laxity and postural changes. Transverse abdominis (TrA) and pelvic floor muscle (PFM) activity is important for lumbo-pelvic stability. The purpose of this study was to compare the effect of stabilization exercise (SE) and general exercise (GE) on TrA and PFM muscle activity and pain intensity in women with postpartum LPP. A randomized controlled trial study was conducted on 68 women with postpartum LPP. Patients were randomly divided into two groups of stabilization exercise (SE) and general exercise (GE) and received either SE or GE exercise for 8weeks three times a week. Ultrasound imaging was utilized to measure the thickness change of TrA muscles during abdominal hollowing (AH) and bladder base displacement. These measurements were used as an indicator of TrA and PFM muscle activity. Pain intensity, thickness changes of the TrA muscle and bladder base displacement were measured pre- and post-intervention. The results showed that there was no significant difference in pain relief after intervention between groups. The differences in TrA and PFM activity between groups were significant (P < 0.05). PFM and TrA muscle activity was significantly increased after SE in women with postpartum LPP (P < 0.05). SE improved both PFM and TrA muscle function more than GE in women with postpartum LPP. However, the clinical outcome of pain relief was not greater in the SE group.

The Effect of High-Dose Vitamin C on Biochemical Markers of Myocardial Injury in Coronary Artery Bypass Surgery.

ObjectiveTo evaluate the effect of high-dose vitamin C on cardiac reperfusion injury and plasma levels of creatine kinase-muscle/brain (CK-MB), troponin I, and lactate dehydrogenase (LDH) in patients undergoing coronary artery bypass grafting (CABG).MethodsThis is a double-blind randomized clinical trial study. Fifty patients (50-80 years old) who had CABG surgery were selected. The intervention group received 5 g of intravenous vitamin C before anesthesia induction and 5 g of vitamin C in cardioplegic solution. The control group received the same amount of placebo (normal saline). Arterial blood samples were taken to determine the serum levels of CK-MB, troponin I, and LDH enzymes. Left ventricular ejection fraction was measured and hemodynamic parameters were recorded at intervals.ResultsHigh doses of vitamin C in the treatment group led to improvement of ventricular function (ejection fraction [EF]) and low Intensive Care Unit (ICU) stay. The cardiac enzymes level in the vitamin C group was lower than in the control group. These changes were not significant between the groups in different time intervals (anesthesia induction, end of bypass, 6 h after surgery, and 24 h after surgery) for CK-MB, LDH, and troponin I. Hemodynamic parameters, hematocrit, potassium, urinary output, blood transfusion, arrhythmia, and inotropic support showed no significant difference between the groups.ConclusionVitamin C has significantly improved the patients’ ventricular function (EF) 72 h after surgery and reduced the length of ICU stay. No significant changes in cardiac biomarkers, including CK-MB, troponin I, and LDH, were seen over time in each group.IRCT codeIRCT2016053019470N33

Effects of Melatonin Administration on Chemical Pregnancy Rates of Polycystic Ovary Syndrome Patients Undergoing Intrauterine Insemination: A Randomized Clinical Trial.

BackgroundOxidative stress as a potential cause of poor oocyte quality can influence a female’s reproductive system. This study aimed to investigate the effects of melatonin on chemical pregnancy rates of a significant number of polycystic ovary syndrome (PCOS) patients undergoing intrauterine insemination (IUI).Materials and MethodsIn this double-blinded randomized clinical trial (RCT) study, the samples included 198 PCOS patients fulfilling the inclusion criteria and undergoing the IUI treatment. On the third day of menstruation, a 3-mg melatonin tablet or its placebo was given to the patients according to the randomized study protocol; this prescription was continued until the day of human chorionic gonadotropin (hCG) administration. The current study attempted primarily to scrutinize the effect of melatonin administration on the rate of chemical pregnancy and mature follicles during the IUI treatment cycle, and secondarily to determine the endometrial thickness (ET) on the day of IUI.ResultsThe mean age of the participants in the study was 28.9 ± 5.5 years. The chemical pregnancy rate in the group receiving melatonin was about 32%, when it was 18% in the control group (P=0.012). Furthermore, it was concluded that the addition of melatonin to the treatment cycle of PCOS individuals could significantly improve the ET after the treatment (P<0.001).ConclusionThe results of this study demonstrated that the treatment of PCOS patients undergoing IUI with mela- tonin significantly improves the rate of chemical pregnancy (Registration number: IRCT2017021132489N1).

Anti-coagulation therapy following coronary endarterectomy in patient with coronary artery bypass graft.

Background:Since there is a lack of research on postoperative anticoagulation protocol in patients undergoing coronary artery bypass graft (CABG) / coronary endarterectomy (CE), we recommend a new protocol for anticoagulation in these patients.Methods:In this double-blind randomized clinical trial study, 52 patients undergoing CABG / CE entered the study and were divided into two groups. In group 1, the patients were given warfarin(international normalized ratio (INR) between 2-3) together with 80 mg aspirin daily for 3 months. In group 2, the patients were given 75 mg plavix daily together with 80 mg aspirin daily for 3 months. We evaluated patients with electrocardiography, echocardiography and checking ceratin phosphokinase MB and troponin I in the several stages. The data were analysed SPSS Version18 software.Results:There was no significant difference between pre and post-operative Ejection fraction in patients with plavix (P=0.21) and warfarin (P=0.316) regimen. However, wall mrotion score was significantly better in clopidogrel – aspirin patients in late (3 months) post operation (p<0.001).Conclusions:Since warfarin has serious hemorrhagic complications and requires closed monitoring of serum drug activity by serial INR checking, it is recommended that clopidogrel – aspirin can be the preferred alternative anticoagulation therapy in CABG / CE patients.

Effects of Interferential Electrical Stimulation Plus Pelvic Floor Muscles Exercises on Functional Constipation in Children: A Randomized Clinical Trial.

Functional constipation is a common condition in children. We assessed the effectiveness of combined interferential (IF) electrical stimulation and pelvic floor muscle (PFM) exercises on functional constipation in children. We conducted a single-center, double-blind randomized clinical trial study during 2014-2017 in Tehran, Iran. Ninety children, aged 5-13 years, who fulfilled Rome III criteria were enrolled and randomly assigned into two treatment groups. Case group (n=45) underwent IF electrical stimulation and PFM exercises, whereas the control group (n=45) received PFM exercises plus sham stimulation. A complete bowel habit diary (with concerning data on the frequency of defecation per week, stool form, and the number of fecal soiling episodes), a constipation score questionnaire, and a visual pain score were recorded before, after the treatment and 6 months later for all participants. In addition, children in both groups were assessed with a constipation-related quality-of-life questionnaire before, after the end of treatment sessions, and 6 months after the treatment. Treatment success was achieved for 88.4% of children in the case group compared with 43.2% of children in the control group after the treatment (P<0.003). The median constipation score was reduced in both groups, with the cases having significantly lower scores after the treatment (4 vs. 8, P<0.000). Stool form normalized in 75.6% of the cases and 45.5% of the controls after the treatment (P<0.01). Our results showed that using IF electrical stimulation as an adjuvant therapy to the medical and rehabilitation programs significantly boosts the effects of treatment among these patients.

The clinical evaluation of Vi-one chlorhexidine mouthwash on plaque-induced gingivitis: A double-blind randomized clinical trial.

BackgroundChlorhexidine (CHX) is the most effective antiseptic mouthwash to date. Essential oil such as thymol, have inhibitory and biocidal effects a range of bacteria.ObjectiveTo determine the effect of mouthwash containing CHX and thymol on plaque induced gingivitis.MethodsThis double-blind randomized clinical trial study was performed on 60 patients with plaque induced gingivitis who were randomly divided into two groups: Group I (CHX/thymol mouthwash-Vi-one) and Group II (CHX mouthwash-Behsa). Patients in each group underwent scaling and root planning and polishing, then were educated about BASS-Method brushing, and were recommended Oral-B toothbrushes and Pooneh toothpaste. The two groups were asked to rinse their mouths for 60 seconds twice a day, once in the morning and once at night, after brushing their teeth. Plaque index, gingival index, bleeding index and stain index were evaluated at baseline and 14 days later in Ramfjord teeth. Data analysis was conducted using SPSS version 21. Independent-samples t-test and paired-samples t-test were used for data analysis.ResultsThe results showed that plaque index and gingival index significantly reduced in two groups (p<0.001). However, group I was significantly more efficient than group II (p<0.001, p=0.021 respectively). Similar results were observed in terms of bleeding index with the difference that the two groups did not differ significantly from each other (p=0.879). Both groups significantly increased the stain index. No remarkable difference was also observed between the two groups (p=0.754).ConclusionBased on the results of this study, we can conclude that the CHX/thymol mouthwash can be offered to patients with dental plaque-induced gingivitis, because it appears to be more effective in controlling dental plaque and gingivitis.Trial registrationThe trial was registered at the Iranian Registry of Clinical Trials (http://www.irct.ir) with the Irct ID: IRCT201602231760N45.FundingThis study was part of a thesis and research project (Grant No: 9440921) supported and funded by Babol University of Medical Sciences. The authors received no financial support from Behsa pharmaceutical company (Behsa mouthwash manufacturer) or Rojin cosmetic laboratory (Vi-one mouthwash manufacturer) for this study.

Effect of Nepeta bracteata Benth. on allergic rhinitis symptoms: A randomized double-blind clinical trial.

Background:Allergic rhinitis (AR) is one of the health problems in the world. It is necessary to develop new treatment procedure for control of this disease. The aim of this study was to assess the effect of Zofa (Nepeta bracteata Benth) on AR patients.Materials and Methods:In this double-blind randomized clinical trial study, 71 patients (37 patients in treatment and 34 in placebo group) participated. In treatment group, N. bracteata syrup (NBS) was used for 4 weeks as three times a day. The efficacy of the drug regarding AR symptoms (rhinorrhea, sneezing, nasal obstruction, itchy nose, and ocular symptoms) were evaluated through a visual analog scale (VAS) by 0–10 before administration and at the end of the whole treatment period. The collected information was entered in the SPSS software (version 18) and was analyzed using the Fisher's exact test, Chi-square test, independent sample t-test, and paired sample test.Results:The improvement of AR symptoms in the group receiving NBS was significantly higher compared to control group (4.73 ± 1.84 vs. 0.38 ± 2.06; P < 0.0001). Furthermore, the mean of total VAS before and after the treatment (in case group) was 7.10 ± 1.92 and 2.37 ± 1.76, respectively (P < 0.001).Conclusion:The results of this study indicate that N. bracteata has significant effects on improving the symptoms of AR. Hence, it can be a good alternative to AR symptoms relief.

Comparison the Effects of Intraoperative Labetalol and Lidocaine on Postoperative Blood Pressure and Heart Rate in Brain Surgeries.

Background:Long-term anesthesia applied in some operations, especially in neurosurgical operations leads to unwanted complications. This study aimed to compare the effect of intraoperative labetalol and lidocaine injection on the rate of changes in postoperative blood pressure and heart beat in patients undergoing brain operation.Materials and Methods:This is a simple double-blind randomized clinical trial study conducted in Al-Zahra and Kashani Hospitals on 90 patients’ candidate for craniotomy operation with the age range of 18–65 years, Glasgow Coma Scale (GCS) ≥13 before anesthesia, physical class of American Society of Anesthesiologists I, II, insensitivity to labetalol who were divided into two groups of 45 individuals in the random allocation method. To start anesthesia, fentanil 1.5 mg per 1 kg of body weight, midazolam 5 mg, propofol 2 mg/kg and then, atracurium 0.15 mg/kg and lidocaine 1.5 mg/kg were used. The rate of patients’ bucking and blood pressure were checked at GCS time after operation and in patients’ recovery in terms of 0, 5, 10, 20 and 30 min after arrival in the recovery room and 1 h later.Results:There was no significant difference in terms of hemodynamic parameters during the period of operation and recovery and at the time of extubation and during the study, no case of bradicardia, hypotension, tachycardia or hypertension was observed in the patients of both groups.Conclusion:Using labetalol in craniotomy surgery is helpful for two main reasons that are the proper control of intraoperative and postoperative blood pressure and prevention of postoperative reactions, especially cough and if there is no contraindication for using it, it is recommended.

Effect of Low-dose Atracurium on Laryngeal Mask Airway Insertion Conditions: A Randomized Double-blind Clinical Trial.

Background:The amount of sedation and muscle relaxation of the jaw may have an impact on complications caused by laryngeal mask airway (LMA). The aim of this study is to evaluate the effect of low-dose Atracurium on conditions of insertion, complications, and hemodynamic responses to LMA insertion following induction of anesthesia with propofol, in patients undergoing cataract surgery.Patients and Methods:In this double-blind randomized clinical trial study, 60 patients were randomly divided into two groups. Initially, the patients in the study group received 0.15 mg/kg intravenous injection of atracurium, and the patients in the control group received 2 ml of intravenous injection of normal saline, after which anesthesia in both groups were induced with midazolam, fentanyl, lidocaine, and propofol. The amount of jaw relaxation, ease of insertion, and the time needed for insertion, hemodynamic responses and complications of LMA insertion were evaluated.Results:Jaw relaxation and ease of LMA insertion in the study group was significantly better than that of the control group (P = 0.02). Average time needed for LMA placement in the study group (5/06 ± 0.52 second) was significantly lower than the control group (5/76 ± 0.67 second) (P = 0.001). Hemodynamic response to LMA insertion was similar in both groups. Sore throat at recovery and 24 h after surgery in the control group was significantly higher than that of the study group (3/30 vs. 10/30) (P = 0.01).Conclusions:Using low doses of atracurium decreases the time needed for LMA insertion and sore throat after the operation. Atracurium also increases jaw relaxation and facilitates the placement of LMA.

Impact of morphine use in reducing the need for CT scan in patients with cervical spine trauma: a double blinded randomized clinical trial.

BackgroundCervical spine trauma occurs mostly among young males due to falls and car accidents. The CT scan technology is replacing radiography in many medical clinics as it is very capable in detecting subtle cervical spine injuries. However, the use of CT scan for routine screening in patients with cervical spine trauma remains controversial due to its radiation risks and relatively high cost.ObjectiveThe focus of this research was on using morphine in patients with cervical spine trauma. The objective was to determine the ability of morphine to reduce the number of patients in need of CT scans.MethodsThis double-blinded randomized clinical trial study was conducted from April 2014 to March 2015 in Hasheminejad Hospital in Mashhad, Iran. We enrolled 67 patients with cervical spine trauma and normal radiography in the study. They were divided randomly into two groups (groups A and B), where group A received intravenous morphine, and group B received a placebo. We measured the pain scores in both groups before giving the medication and 10 minutes afterwards using a visual analog scale (VAS).ResultsAs a result of receiving morphine, the patients in group A had significantly lower pain than group B (p-value < 0.001). The average pain score in group A was reduced by 43% versus 23% in group B. However, the most pain reduction was in those in group A with a normal CT scan. The pain score of these patients dropped by 52%.ConclusionsThe findings of this study suggest that patients with a normal radiography may be discharged with a cervical collar without a need for a CT scan if morphine reduces their pain. This is because the pain in these patients stem from the muscles and non-bony structures in the cervical spine area. Clinical trial registration: The trial was registered at the Iranian Registry of Clinical Trials (http://www.irct.ir) with the IRCT ID: IRCT2013100214872N1FundingThe authors received no financial support for the research or for the publication of this article.

Comparison of short-term postoperative complications of thyroidectomy using ligature and suture ligation.

Background:Thyroidectomy is one of the most common forms of operations in general surgery. Regarding the status and importance of thyroidectomy and protective measures for avoiding the surgical complications, we aimed at investigating the short-term postoperative complications of thyroidectomy by applying the two methods of ligature use and suture ligation of vessels.Settings:Department of Surgery, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.Materials and Methods:This Double-blind randomized clinical trial study conducted on 140 candidates of thyroidectomy. The patients were randomlyequally allocated assigned to two groups of 70. In the ligature group, thyroidectomy was performed via ligature use, and in the suture ligation group, it was done with suture ligature. Using a specific questionnaire, the required demographic information, type of surgical operation, duration of surgery, rate of bleeding, the preoperative and postoperative serum calcium concentration, hypocalcemia symptoms, hoarseness, and laryngoscopic findings were collected and analyzed.Results:The findings revealed that the average time of total and subtotal thyroidectomy lasted 93.94 ± 10.53 min with ligature use and 134.15 ± 13.57 min with suture ligation. No case of postoperative bleeding was observed in this study. Two patients (17.1%) in the suture ligation group and two patients in the ligature group showed signs of hypocalcemia. Six patients developed hoarseness of whom five belonged to the ligature group and one belonged to the suture ligation group.Conclusions:Regarding the fact that on the whole, duration of thyroidectomy was shorter in ligature approach compared to the suture ligation, it can be considered as a suitable method to substitute suture ligation. However, meticulous precautions should be taken specifically with regard to the efferent laryngeal nerve and hoarseness.

Comparison of Two Marketed Hydroxypropyl Methylcellulose Based Artificial Tear Drops in Young Patients with Dry Eye Syndrome

Background: Artificial tears have been among the first line of therapy in management of Dry Eye Syndrome (DES). This study was conducted to compare a local artificial tear with an imported one in reduction of DES. This comparison would help to evaluate the cost and benefits of each drop in the proper management of DES. M aterials and Methods: In this double-blind randomized clinical trial study, a total 65 students meeting our inclusion criteria for DES entered the study. The OSDI questionnaire, TBUT, corneal and conjunctival staining and Schirmer test, were performed. The patients were divided into two groups by block randomization. Group 1 received first drop and group 2 received second drop. Both groups were instructed to use the drops 4 times a day for 14 days. The same tests were performed by the same examiner who was blind to the treatment type after two weeks. Repeated measured ANOVA was used to analyze the data. R es ults: A total of 58 patients completed the study. In both groups, after the intervention, the OSDI scores (P<0.001), TBUT score (P=0.041), corneal (P<0.001) and conjunctival staining scores (P<0.001) showed improvement in compare to those before the intervention. However, the Schirmer test score did not show significantly difference before and after intervention. In comparing two groups the OSDI scores, the TBUT score, the corneal and conjunctival staining scores and the Schirmer scores did not show statistically significant difference. Conclusion : The two artificial tears equally reduced the symptoms and signs of DES in two weeks .

The effect of topical olive oil on the healing of foot ulcer in patients with type 2 diabetes: a double-blind randomized clinical trial study in Iran

BackgroundDiabetic Foot Ulcer (DFU) is the most costly and devastating complication of diabetes mellitus which can lead to infection, gangrene, amputation, and even death if the necessary care is not provided. Nowadays, some herbal products have shown therapeutic effects on healing of DFU. So, this study aimed to assess the effects of topical olive oil on the healing of DFU.MethodsThis double-blind randomized clinical trial study was conducted in Diabetes Clinic of Ahvaz Golestan hospital, Iran, in 2014. Thirty-four patients with DFU of Wagner’s ulcer grade 1 or 2 were enrolled in this study. Patients who were randomly assigned to intervention group (n = 17) received topical olive oil in addition to routine cares, whereas patients in control group (n = 17) just received routine cares. Intervention was done once a day for 4 weeks in both groups, and in the end of each week; the ulcers were assessed and scored. Data was collected by demographic and clinical characteristics checklists as well as diabetic foot ulcer healing checklist, and was analyzed by SPSS version 19 software using descriptive (mean and standard deviation) and analytic (student’s sample t-test, chi-square and repeated-measures analysis of variance) statistics.ResultsAt the end of 4th week, there was a significant differences between two groups regarding to 3 parameters of ulcer including degree (P = 0.03), color (P = 0.04) and surrounding tissues (P < 0.001) as well as total status of ulcer (P = 0.001), while related to ulcer drainages no significant difference was seen between the two groups (P = 0.072). At the end of the follow up, olive oil significantly decreased ulcer area (P = 0.01) and depth (P = 0.02) compared with control group. Complete ulcer healing in the intervention group was significantly greater than control group (73.3% vs. 13.3%, P = 0.003) at the end of follow up. Also, there were no adverse effects to report during the study in intervention group.ConclusionsOur results indicated that olive oil in combination with routine cares is more effective than routine cares alone, and is without any side effect. However, further studies are required in the future to confirm these results.Trial registrationIRCT2014083014251N2.Electronic supplementary materialThe online version of this article (doi:10.1186/s40200-015-0167-9) contains supplementary material, which is available to authorized users.

Geranisetron versus gabapentin in preventing postoperative nausea and vomiting after middle ear surgery in adults: A double-blinded randomized clinical trial study.

Background:The incidence of postoperative nausea and vomiting (PONV) after middle ear surgery is high. In this study we want to compare the effects of intravenous granisetron and oral gabapentin as a premedication before surgery on the incidence and severity of PONV after middle ear surgery in adult patents.Materials and Methods:We enrolled 90 patients that were randomly divided into the three groups of 30 in each. Group I received granisetron 3 mg iv 2 minutes before induction of anesthesia; Group II received oral gabapentin 300 mg 1 hour before anesthesia and Group III received placebo. The incidence and severity of PONV were recorded each 15 minutes in the post-anesthesia care unit (PACU) and each 8 hours until 24 hours after discharge from the PACU.Result:The incidence and severity of nausea and vomiting at different time intervals in Groups I and Group II was significantly lower compared with Group III (P < 0.05). There was no significant difference in the incidence of side effects of study drug administration including respiratory depression, apnea, extra pyramidal disorders, drowsiness, dizziness, vertigo and headache in three groups.Conclusion:The study was shown that using gabapentin and granisetron have equal anti-emetic effects, but significant differences were seen between these two groups compared to the control group. These submit the efficiency of these drugs in preventing PONV.

Effect of ketamine as an adjuvant in ultrasound-guided supraclavicular brachial plexus block: A double-blind randomized clinical trial study.

Background:Supraclavicular brachial plexus block is one of the most effective anesthetic procedures in operations for the upper extremity. Ketamine has been reported to enhance the analgesic effects of local anesthetics. We have conducted this study to assess whether coadministration of ketamine can prolong the local analgesic effect of lidocaine in the supraclavicular brachial plexus block for patients undergoing elective upper extremity surgery.Materials and Methods:Sixty adult patients undergoing elective surgery of the elbow, forearm, wrist or hand were randomly allocated in two groups of 30 patients each. Group 1 (ketamine group) received 5 mg/kg lidocaine 1.5% plus 2 mg/kg ketamine, Group 2 (control group) received 5 mg/kg lidocaine 1.5% and saline. The outcome measures included severity of pain by using visual analog scale (VAS, 0 = no pain 10 cm = the most severe pain), time of first request for analgesia, and total dose of postoperative opioid administration. The data was analyzed using the χ2 test, student's t-test, Kaplan-Meier survival analysis, and Multivariate analysis tests.Results:Patients in the control group had a higher VAS than patients who received ketamine, at all time points during the first 24 hours after surgery (all P < 0.05). The time of first request for analgesia in the ketamine group was significantly more than in the control group (8.93 ± 1.0 vs. 7.30 ± 1.9, respectively, P < 0.001).Conclusion:The addition of ketamine to lidocaine in the ultrasound-guided brachial plexus block could decrease the postoperative pain and need for analgesic. Therefore, it could be considered as an option in the brachial plexus block to enhance the analgesic action of lidocaine.

The Prophylactic Effects of Zintoma and Ibuprofen on Post-endodontic Pain of Molars with Irreversible Pulpitis: A Randomized Clinical Trial.

Post endodontic pain is often linked to the inflammatory process as well as additional central mechanisms. The purpose of the present double-blind randomized clinical trial study was to compare the prophylactic effects of a derivative of Zingiber Officinale, Zintoma, and Ibuprofen on post endodontic pain of molars with irreversible pulpitis. The post endodontic pain of 72 enrolled patients suffering from irreversible pulpitis was assessed after prophylactic use of 400 mg Ibuprofen, 2 gr Zintoma and placebo. Using the Heft-Parker Visual Analogue Scale, the patients recorded their perceived pain before taking the medicament (baseline), immediately after and also at 4, 8, 12, 24, 48, and 72 h post one-visit endodontic treatment. The statistical analysis was done using Kruskal-Wallis, Mann-Whitney, and Freedman tests (P<0.05). At all times, there was significant difference between the Ibuprofen and Zintoma (P<0.05) and also between the Ibuprofen and placebo (P<0.05). However, there was no significant difference between Zintoma and the placebo in any of time intervals (P>0.05). No side effects were observed. The obtained results of the trial revealed that prophylactic use of 2 gr Zintoma is not an effective pain relieving agent.