Granisetron In Patients Research Articles

Adjunctive granisetron therapy in patients with sepsis or septic shock (GRANTISS): A single-center, single-blinded, randomized, controlled clinical trial.

Background: In preclinical experiments, we demonstrated that the 5-HT3 receptor antagonist granisetron results in reduced inflammation and improved survival in septic mice. This randomized controlled trial was designed to assess the efficacy and safety of granisetron in patients with sepsis. Methods: Adult patients with sepsis and procalcitonin≥2ng/ml were randomized in a 1:1 ratio to receive intravenous granisetron (3mg every 8h) or normal saline at the same volume and frequency for 4days or until intensive care unit discharge. The primary outcome was 28-day all-cause mortality. Secondary outcomes included the duration of supportive therapies for organ function, changes in sequential organ failure assessment scores over 96 h, procalcitonin reduction rate over 96 h, the incidence of new organ dysfunction, and changes in laboratory variable over 96h. Adverse events were monitored as the safety outcome. Results: The modified intention-to-treat analysis included 150 septic patients. The 28-day all-cause mortalities in the granisetron and placebo groups were 34.7% and 35.6%, respectively (odds ratio, 0.96; 95% CI, 0.49-1.89). No differences were observed in secondary outcomes. In the subgroup analysis of patients without abdominal or digestive tract infections, the 28-day mortality in the granisetron group was 10.9% lower than mortality in the placebo group. Adverse events were not statistically different between the groups. Conclusion: Granisetron did not improve 28-day mortality in patients with sepsis. However, a further clinical trial targeted to septic patients without abdominal/digestive tract infections perhaps is worthy of consideration.

Transdermal versus oral granisetron in controlling chemotherapy-induced nausea and vomiting: a meta-analysis.

To compare the efficacy of transdermal granisetron versus oral granisetron in controlling chemotherapy-induced nausea and vomiting (CINV) in patients with cancer METHODS: Data sources were CENTRAL, MEDLINE, EMBASE, Clinicaltrials.gov , and Google Scholar. Inclusion criteria included randomized controlled trials comparing transdermal versus oral granisetron in patients with CINV. For data extraction, two authors independently analyzed the methodological quality and extracted data. A random effects model was used to estimate the risk ratio (RR) or odds ratio (OR) with 95% confidence interval (CI). Three studies (1086 patients) were included. Oral granisetron is superior (OR 0.77; 95% CI 0.60 to 0.99) to its transdermal form in achieving complete control of CINV in patients receiving chemotherapy. As for the risk of constipation (RR 1.32; 95% CI 0.73 to 2.40) and QTc prolongation (RR 0.17; 95% CI 0.02 to 1.40) as adverse effects, no statistically significant difference was observed between the two routes. Oral granisetron is better in achieving complete control of CINV in patients receiving chemotherapy. As for the risk of constipation and QTc prolongation as adverse effects, there was no statistically significant difference between the two routes.

Economic analysis of palonosetron versus granisetron in the standard triplet regimen for preventing chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy in Japan (TRIPLE phase III trial)

BackgroundWe conducted an economic assessment using test data from the phase III TRIPLE study, which examined the efficacy of a 5-hydroxytryptamine 3 receptor antagonist as part of a standard triplet antiemetic regimen including aprepitant and dexamethasone in preventing chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy (HEC).MethodsWe retrospectively investigated all medicines prescribed for antiemetic purposes within 120 h after the initiation of cisplatin administration during hospitalization. In the TRIPLE study, patients were assigned to treatment with granisetron (GRA) 1 mg (n = 413) or palonosetron (PALO) 0.75 mg (n = 414). The evaluation measure was the cost-effectiveness ratio (CER) assessed as the cost per complete response (CR; no vomiting/retching and no rescue medication). The analysis was conducted from the public healthcare payer’s perspective.ResultsThe CR rates were 59.1% in the GRA group and 65.7% in the PALO group (P = 0.0539), and the total frequencies of rescue medication use for these groups were 717 (153/413 patients) and 573 (123/414 patients), respectively. In both groups, drugs with antidopaminergic effects were chosen as rescue medication in 86% of patients. The costs of including GRA and PALO in the standard triplet antiemetic regimen were 15,342.8 and 27,863.8 Japanese yen (JPY), respectively. In addition, the total costs of rescue medication use were 73,883.8 (range, 71,106.4–79,017.1) JPY for the GRA group and 59,292.7 (range, 57,707.5–60,972.8) JPY for the PALO group. The CERs (JPY/CR) were 26,263.4 and 42,628.6 for the GRA and PALO groups, respectively, and the incremental cost-effectiveness ratio (ICER) between the groups was 189,171.6 (189,044.8–189,215.5) JPY/CR.ConclusionsWe found that PALO was more expensive than GRA in patients who received a cisplatin-based HEC regimen.

Compare the Efficacy of Prochlorperazine and Granisetron in Patients Undergoing Total Abdominal Hysterectomy

Compare the Efficacy of Prochlorperazine and Granisetron in Patients Undergoing Total Abdominal Hysterectomy

O3–004 - Palonosetron Improves Dietary Intake Compared to Granisetron in Patients Undergoing Highly Emetogenic Chemotherapy

Background: Selection of first- and second-generation 5HT3-receptor antagonists for highly emetogenic chemotherapy (HEC) is not included in JSCO guidelines for proper use of antiemetic agents, and a phase III trial entitled the TRIPLE study is currently underway.

Steroid kullanan supratentoryal kitle olgularında intravenöz granisetron ve ondansetron uygulamalarının postoperatif bulantı, kusma üzerine olan etkilerinin karşılaştırılması

Comparison of the effects of granisetron and ondansetron on postoperative nausea and vomiting in supratentorial tumor patients using steroids Objective: Postoperative nausea and vomiting (PONV) delays patient discharge and increases recovery room stays and recovery time. Furthermore, it increases the bleeding risk by causing increased intracranial pressure after craniotomy. The aim of this study was to compare the efficacy of steroids or steroids combined with ondansetron and granisetron in patients undergoing intracranial surgery. Methods: The study was conducted on the patients undergoing supratentorial tumor surgery in the neurosurgery unit. 90 patients, classified as ASA physical status I and II, aged between 17-70 were included in this study. The study was planned as a prospective, randomized, double-blinded study. All the patients were medicated with 4 mg dexamethasone intravenously every 6 hours for the postoperative 24 hours. All patients had general anesthesia. Dura mater was turned off at the end of the surgery, and the patients were divided into 3 groups. Group 1 was treated with saline, Group 2 was treated with 8 mg ondansetron, and Group 3 was treated with 8 mg granisetron. Durations of operation and anesthesia, verbal destructive scale values for nausea at the postoperative 0 th , 2 nd , 4 th , 6 th , 8 th , 12 th , 16 th , 24 th hours, existence of vomiting, use of antiemetics, and side effects were collected. Results: The nausea score distributions of Group 1, Group 2 and Group 3 between 0th to 10 th hour were significantly different (p=0.0001). Nausea scores in Group 1 were significantly higher than Groups 2 and 3, whereas the difference between Group 1, Group 2 and Group 3 was found statistically insignificant between 12 th to 24 th hours. The nausea score distributions of the control group for the first 6 hours, ondansetron group for the first 4 hours and granisetron group for the first hour were significantly higher when compared to the other times. The existence of vomiting in Group 1, Group 2 and Group 3 was significantly different between 0 th to 10 th hour (p=0.0001). The existence of vomiting in Group 1 was significantly higher than Group 2 and Group 3. But there was no significant difference between the groups in terms of existence of vomiting between 12 th to 24 th hours. The existence of vomiting in control group for the first 4 hours and in the ondansetron group for the first 2 hours were significantly higher than the other times, whereas no vomiting was observed in granisetron group. The distribution of the need for antiemetic use between Group 1, Group 2 and Group 3 was found to be significantly different (p=0.02). The need for antiemetic use in Group 1 was significantly higher from that of Groups 2 and 3. No side effects were observed in any group.

Response: Comparative electrocardiographic effects of intravenous ondansetron and granisetron in patients undergoing surgery for carcinoma breast: A prospective single blind randomised trial

Background: Postoperative nausea and vomiting (PONV) are common and distressing symptoms after surgery performed under general anaesthesia. 5-hydroxytryptamine 3 antagonists are routinely used for prevention and treatment of PONV. The aim of our study was to compare the incidence of QTc prolongation and quantify the amount of QTc prolongation with ondansetron and granisetron. Methods: This prospective, randomised, single-blind study was carried out in the OT and Recovery Room (RR) of a tertiary referral cancer centre. After obtaining Institutional Review Board approval and written informed consent from the patients, 70 patients undergoing elective surgery for carcinoma breast were included. In the RR, patients randomly received 8 mg of ondansetron or 1 mg of granisetron intravenously. Serial ECGs were recorded at various intervals, Non-invasive blood pressure and SpO 2 were also recorded. Chi-square test and Mann-Whiteny test were used for statistical analysis. Results: The demographics were similar in both groups. The incidence of significant QTc prolongation was significantly higher in the ondansetron group (22 of 37 (59.4%) vs. 11 of 33 patients (33.33%) ( P Conclusion: Granisetron may be a safer option than ondanasetron for prevention and treatment of PONV due to lesser prolongation QTc interval. (ClinicalTrials.gov ID: NCT01352130)

Comparative electrocardiographic effects of intravenous ondansetron and granisetron in patients undergoing surgery for carcinoma breast: A prospective single-blind randomised trial

Background:Postoperative nausea and vomiting (PONV) are common and distressing symptoms after surgery performed under general anaesthesia. 5-hydroxytryptamine3 antagonists are routinely used for prevention and treatment of PONV. The aim of our study was to compare the incidence of QTc prolongation and quantify the amount of QTc prolongation with ondansetron and granisetron.Methods:This prospective, randomised, single-blind study was carried out in the OT and Recovery Room (RR) of a tertiary referral cancer centre. After obtaining Institutional Review Board approval and written informed consent from the patients, 70 patients undergoing elective surgery for carcinoma breast were included. In the RR, patients randomly received 8 mg of ondansetron or 1 mg of granisetron intravenously. Serial ECGs were recorded at various intervals, Non-invasive blood pressure and SpO2 were also recorded. Chi-square test and Mann-Whiteny test were used for statistical analysis.Results:The demographics were similar in both groups. The incidence of significant QTc prolongation was significantly higher in the ondansetron group (22 of 37 (59.4%) vs. 11 of 33 patients (33.33%) (P<0.05)). There was an increase in the QTc interval in both the groups as compared to the baseline. The median prolongation in QTc interval from baseline was much more in the ondansetron group; this was statistically significant only at 5 and 15 min.Conclusion:Granisetron may be a safer option than ondanasetron for prevention and treatment of PONV due to lesser prolongation QTc interval. (ClinicalTrials.gov ID: NCT01352130)

Retraction Note to: Prophylactic antiemetic efficacy of granisetron in patients with and without previous postoperative emesis

Further to the Expression of Concern posted online on March 13th, 2012, it is with considerable regret that the Canadian Journal of Anesthesia hereby retracts the above-cited article by Dr. Yoshitaka Fujii as a result of:(1) overwhelming evidence of fabrication relating to the fact that the distributions of many variables reported by Dr. Fujii in these studies are exceedingly unlikely; and the inability of Dr. Fujii’s institution to attest to the integrity of the study and/or the data conducted under its auspices, as set out in the Joint Editors-in-Chief Request for Determination of April 9, 2012. We extend our sincere appreciation to Toride Kyodo General Hospital for their review of the status of Dr. Fujii’s research and to the investigating committee for their review of his research findings.

Use of transdermal and intravenous granisetron and the ability of the Hesketh score to assess nausea and vomiting induced by multiday chemotherapy

PurposeHesketh scores define emetogenicity of single-agent and multiagent single-day chemotherapy. This analysis determined the emetogenicity of multiagent, multiday chemotherapy and the Granisetron Transdermal System (GTDS; Sancuso®).MethodsThis was a retrospective analysis of a multicenter, randomized, double-blind, phase III noninferiority trial of GTDS versus oral granisetron in patients receiving 3 days of multiagent moderately or highly emetogenic chemotherapy, regardless of granisetron formulation. Emesis was defined as vomiting/retching or the use of rescue medication. Logistic regression and classification trees were used to determine the optimal combination of Hesketh scores over the multiagent, multiday regimens for the prediction of emesis.ResultsOf 393 patients, 272 (69.2%) were chemotherapy naïve. The most common types of cancer were lung (30.5%) and gynecologic (21.9%). The most common chemotherapeutic regimen (in 14.2% of patients) was cisplatin plus etoposide on days 1–3. The best binary emesis predictor was day 1 Hesketh score. Patients with a day 1 Hesketh score of 5 had the highest rate of emesis (62.5%) versus patients with a score < 5 (31.7%). For patients with day 1 Hesketh score < 5, only 14.3% of those receiving only one drug on day 1 experienced emesis.ConclusionHesketh emetogenicity scores of individual agents are applicable to multiday, multiagent chemotherapeutic regimens in patients receiving antiemetics.

Cardiac effects of granisetron in a prospective crossover randomized dose comparison trial

Cardiac side effects of granisetron have been studied mostly in adult patients that are using cardiotoxic chemotherapeutics. There is limited evidence in pediatric age group and no information in pediatric oncology patients with non-cardiotoxic chemotherapeutics. In this prospective, crossover randomized study, the cardiac side effects of granisetron are compared in pediatric oncology patients who had carboplatin based chemotherapy. They were randomized to receive either 10 or 40 μg kg(-1) dose(-1) of granisetron before each cycle of chemotherapy. We drew blood for creatine phosphokinase (CPK), CPK-muscle band (MB) and Troponin-T before and 24 h after administering granisetron. Electrocardiography (ECG) tracings were taken at 0, 1, 2, 3, 6 and 24 h of granisetron. Twenty-four hours Holter ECG monitorisation was performed after each granisetron infusion. A total of 16 patients (median 8.7 years of age) were treated with weekly consecutive courses of carboplatin. There was bradycardia (p = 0.000) in patients that had granisetron at 40 μg/kg and PR interval was shortened in patients that had granisetron at 10 μg/kg dose (p = 0.021). At both doses of granisetron, QTc interval and dispersion were found to be similar. CPK, CK-MB and Troponin-T values were found to be normal before and 24 h after granisetron infusion. As the first study that has studied cardiac side effects of granisetron in patients that are not using cardiotoxic chemotherapeutics, we conclude that granisetron at 40 μg kg(-1) dose(-1) causes bradycardia only. We have also demonstrated that granisetron does not cause any clinically cardiac side effects either at 10 or 40 μg kg(-1) dose(-1). However, our results should be supported by prospective randomized studies with larger samples of patient groups.

Effects of Ondansetron and Granisetron on Postoperative Nausea and Vomiting in Adult Patients Undergoing Laparoscopic Cholecystectomy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Background: Postoperative nausea and vomiting (PONV) are common and potentially distressing adverse events (AEs) associated with surgery and anesthesia. In patients undergoing laparoscopic cholecystectomy (LC) without antiemetic prophylaxis, the incidence of PONV can be as high as 72%. Objective: The aim of this study was to investigate the prophylactic antiemetic effects of ondansetron and granisetron in patients undergoing LC when these agents are administered before the end of surgery. Methods: Patients classified by the American Society of Anesthesiologist's physical status as I or II who were scheduled for elective LC were included in this randomized, double-blind, placebo-controlled study. Anesthesia was induced with thiopental 5 mg/kg and fentanyl 2 μg/kg, and was maintained with isoflurane 1% to 3% in 50% oxygen and 50% nitrous oxide and fentanyl as needed. Approximately 20 to 30 minutes before the end of the surgery, the patients randomly received either IV ondansetron 100 μg/kg (group O), IV granisetron 40 μg/kg (group G), or normal saline (group P). Plasma levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were determined preoperatively and 24 hours postoperatively. The patients were observed for 24 hours for PONV and other possible AEs. Postoperative pain intensity was determined using a 10-cm visual analogue scale. Four-point satisfaction scores were determined at 24 hours. Results: Ninety patients (69 women, 21 men) participated in the study. Demographic characteristics and operative data (duration of surgery and anesthesia and amount of intraoperative fentanyl) were similar in the 3 groups. The only AE reported by patients during the 24-hour observation period was nonsevere headache. The number of patients experiencing headache was similar in group P, group O, and group G (10 [33%] patients, 6 [20%], and 10 [33%], respectively). No significant changes were found in presurgical and postsurgical plasma levels of ALT and AST in any group. The mean (SD) satisfaction scores in group O and group G (3.0 [0.4] and 3.0 [0.6], respectively) were significantly higher than those in group P (2.5 [0.5]; both, P < 0.01). Immediately after surgery (period 0), significantly more patients in the placebo group (21 [70%]) experienced PONV compared with those in the ondansetron group (9 [30%]; P < 0.05) and the granisetron group (7 [23%]; P < 0.01). During the 24-hour observation period, a significantly greater number of patients in group P (18 [60%]) required a single dose of a rescue antiemetic drug compared with those in groups O and G (9 [30%] and 6 [20%], respectively; both, P < 0.01). Conclusions: Patients administered ondansetron 100 μg/kg or granisetron 40 μg/kg 20 to 30 minutes before the end of LC had significantly higher PONV control during the 24-hour postoperative observation period than patients receiving placebo. However, there were no significant differences between the active treatment groups in the incidence of PONV, patient satisfaction, or AEs.

A double-blind, crossover, randomized dose-comparison trial of granisetron for the prevention of acute and delayed nausea and emesis in children receiving moderately emetogenic carboplatin-based chemotherapy

Granisetron is a safe and effective prophylaxis for nausea and vomiting associated with moderate to highly emetogenic chemotherapy. Few trials have been conducted to determine the optimal effective dose of granisetron in children with cancer. The objective of this report was to compare two doses of granisetron in patients with optic pathway tumors receiving moderately emetogenic doses of carboplatin. In this double-blind, crossover, randomized study, antiemetic efficacy and tolerability of two dose levels (10 and 40 microg/kg) of granisetron in the prevention of acute and delayed nausea/emesis were compared in children and young adults. A total of 18 patients (13 boys) aged 1-23 years (median 7.7 years) treated with a moderately emetogenic dose of carboplatin were randomly assigned to receive either 10 or 40 microg/kg of slow granisetron intravenous (i.v.) infusions at alternating cycles of chemotherapy in a blinded fashion until the end of the study period or until their chemotherapy regimen ended. In this way, the patients acted as their own controls. Patients in the granisetron 10 and 40 microg/kg groups received 104 and 121 cycles of chemotherapy, respectively. There was no significant difference in antiemetic efficacy in terms of nausea and emesis between the dose groups in the first 5 days of chemotherapy. The treatment was well tolerated. We conclude that granisetron 10 and 40 microg/kg have comparable efficacy in controlling carboplatin-induced acute and delayed nausea/emesis and is well tolerated in children and young adults.

Alprazolam Significantly Improves the Efficacy of Granisetron in the Prophylaxis of Emesis Secondary to Moderately Emetogenic Chemotherapy in Patients with Breast Cancer

Background: Alprazolam, a newer benzodiazepine, may be useful in the control of nausea and vomiting in breast cancer patients. Methods: Nineteen operable breast cancer patients were included in this randomized prospective crossover open-label trial. Patients received either granisetron (G) alone, or in combination with alprazolam (A). Group A patients received G+A first and then crossed over to G-alone after the 2nd or 3rd cycle. Group B patients received the reverse order. Eighty-four cycles were evaluated. Results: In group A, complete remission (CR) plus major response (MR) was higher (93.9%) with G+A than with G-alone (83.3%; p = 0.0001) in the first 24-hour period. In group B, CR plus MR was higher in G+A cycles (100%) than in G-alone cycles (85.7%; p = 0.035) in the 24-hour period and in the 25- to 129-hour period (92 vs. 90.5%, respectively; p = 0.022). Conclusion: Alprazolam increases the efficacy of granisetron in patients with breast cancer treated with an anthracycline-containing regimen.

Comparative Clinical Study of the Anti-Emetic Effects of Oral Ramosetron and Injected Granisetron in Patients With Malignant Glioma Undergoing ACNU Chemotherapy

The effectiveness of ramosetron tablets and granisetron injection was compared for reducing the frequency of nausea, vomiting, and anorexia in patients with malignant glioma undergoing ACNU chemotherapy. Patients with malignant glioma to be treated with ACNU chemotherapy were randomly assigned to receive oral ramosetron (20 patients) or intravenous granisetron (19 patients) prior to ACNU injection. Gastrointestinal toxicity within 48 hours of ACNU injection was compared to that in patients who had received ACNU chemotherapy with dopamine D2 receptor-blocker as a historical control group. Within 24 hours of the administration of ACNU, 15 of the 20 patients treated with ramosetron and 16 of the 19 treated with granisetron were nausea-free, and 14 of the former and 14 of the latter regained their normal appetite. There was no significant difference in the anti-emetic effects. Ten of the 17 controls experienced no vomiting within 6 hours of the injection of ACNU, five were nausea-free within 24 hours, and two retained their normal appetite within 24 hours. Oral ramosetron has the same anti-anorectic and anti-emetic effects as intravenous granisetron. Ramosetron tablets are less expensive and are easy to take, so should be on the list of first-choice anti-emetic drugs for patients treated with ACNU chemotherapy.

Influence of serotonin on the analgesic effect of granisetron on temporomandibular joint arthritis.

The influence of circulating serotonin (5-HT) on the effects of intra-articular administration of granisetron on temporomandibular joint (TMJ) pain was investigated in 11 patients with chronic polyarthritides. An analgesic effect superior to placebo has been shown previously. The change in TMJ movement pain intensity was negatively correlated to circulating 5-HT; that is, the higher the 5-HT before injection, the greater the reduction of pain intensity. The resting pain intensity reduction was not related to 5-HT. In conclusion, this study indicates a stronger short-term analgesic effect on TMJ movement pain by intra-articular administration of the 5-HT3 receptor antagonist granisetron in patients with high levels of circulating 5-HT.

Granisetron plus alprazolam versus granisetron alone in the control of emesis in patients with operable breast cancer receiving anthracycline containing chemotherapy: A phase III trial

8081 Background: Even with optimal antiemetic treatment, about only 20% of patients are completely free from nausea and vomiting (NV). Benzodiazepines have been previously shown to be useful in the prophylaxis of NV. Alprazolam, a newer benzodiazepine, has antidepressant effect and may be useful in NV control. Methods: Nineteen operable breast cancer patients were included in this randomized prospective crossover open label trial. All of them received 4–6 cycles of single day anthracycline containing chemotherapy. Patients received either granisetron (G) alone 3 mg intravenously 15 minute before chemotherapy and then 2×1 mg per os for 5 days, or in combination with alprazolam (A) 0.5 mg per os starting a night and 15 minutes before chemotherapy and continued 2×0.5 mg per os for 5 days. Group A patients received G+A first and then crossed over G alone after the 2nd or 3rd cycle. Group B patients received the reverse order. Eithy four cycles were evaluated. Results: In Group A, Complete Remission (CR) plus Major Response (MR) rate was higher significantly (93.9%) with G+A than G alone (83.3%) (p=.0001) in the first 24 hour period. In Group B, CR plus MR ratio in G+A cycles (100%) was significantly higher than (85.7%) in G alone cycles (p=0.035) in 24 hour period and in 25–129 hour period (92% v.s. 90.5%, p=0.022). When the data were analyzed independently, CR plus MR ratio was signficantly better in G+A cycles (97%) than in G alone (79%) in 24 hour period (p=0.044). Conclusions: Alprazolam increases the efficacy of granisetron in patients with breast cancer who received anthracycline containing regimen. No significant financial relationships to disclose.

Influence of serotonin on the analgesic effect of granisetron on temporomandibular joint arthritis

The influence of circulating serotonin (5-HT) on the effects of intra-articular administration of granisetron on temporomandibular joint (TMJ) pain was investigated in 11 patients with chronic polyarthritides. An analgesic effect superior to placebo has been shown previously. The change in TMJ movement pain intensity was negatively correlated to circulating 5-HT; that is, the higher the 5-HT before injection, the greater the reduction of pain intensity. The resting pain intensity reduction was not related to 5-HT. In conclusion, this study indicates a stronger short-term analgesic effect on TMJ movement pain by intra-articular administration of the 5-HT3 receptor antagonist granisetron in patients with high levels of circulating 5-HT.

Effects on muscle pain by intramuscular injection of granisetron in patients with fibromyalgia

We have previously reported that the level of 5-HT in the masseter muscle is increased in patients with fibromyalgia as compared with healthy subjects and that high intramuscular level of 5-HT is associated with muscle pain. We have also reported that injection of the 5-HT 3 receptor antagonist granisetron (GRA) into the masseter muscle of healthy subjects reduced pain induced by 5-HT and abolished allodynia/hyperalgesia. The aim of this study was to investigate whether GRA can influence pain and allodynia/hyperalgesia of the masseter muscle in patients with fibromyalgia. Eighteen female patients who met the criteria of fibromyalgia according to the American College of Rheumatology participated in the study. They were examined regarding pain intensity and pressure pain threshold (PPT) over the masseter muscle. One milliliter of GRA (1 mg/ml) was injected into the masseter muscle on one side and 1 ml of isotonic saline on the other side in a randomized and double-blind manner. After the injections, the pain intensity and PPT were recorded during 30 min. The pain intensity increased after injection of saline and to a lower degree after injection of GRA. The PPT increased after injection of GRA, while no such change was observed after saline. The difference between GRA and saline was, however, not significant. Eight of the patients responded to the GRA injection by an increase of PPT during the experimental period that differed from saline. They also showed a tendency to a lower increase of pain intensity after injection of GRA when compared to saline. In conclusion, the results of this study do not prove that injection of the 5-HT 3-antagonist GRA into the masseter muscle influences local pain and allodynia/hyperalgesia in patients with fibromyalgia.

A prospective randomized trial of the anti-emetic efficacy of ondansetron and granisetron during bone marrow transplantation

To determine the comparative anti-emetic efficacy of ondansetron and granisetron in patients undergoing bone marrow transplantation, we performed a double-blind, randomized trial in pediatric and adult patients receiving transplants at the University of Minnesota. The results in 187 patients stratified by age (<18 years, n = 51; > or =18 years, n = 136) were analyzed. The average number of emetic episodes in the entire group from day -7 to 2 was 0.86/day for patients receiving ondansetron and 0.73/day for those receiving granisetron (p = 0.32). No differences were noted between the two drugs in total days of complete or major control of emesis or in the number of requests for additional drugs to alleviate symptoms of nausea. The use of total-body irradiation-containing conditioning regimens was associated with a decreased number of emetic episodes compared with regimens of chemotherapy alone. Perceived nausea was evaluated using a nausea scoring system, and no differences were apparent between the granisetron and ondansetron groups; however, reported nausea was significantly higher in females (p<0.01) and in the adult population (p = 0.05). We conclude that both ondansetron and granisetron provide good control of nausea and vomiting experienced with conditioning regimens for bone marrow transplantation. The relative cost of the drugs within an institution must be considered in developing standard anti-emetic regimens for bone marrow transplantation. Biol Blood Marrow Transplant 1999;5(6):386-93.