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BMC Anesthesiology Apr 2022Direct stimulation of the afferent nerve endings in the venous endothelium is one explanation of propofol injection pain. Previous studies found that ondansetron can... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Direct stimulation of the afferent nerve endings in the venous endothelium is one explanation of propofol injection pain. Previous studies found that ondansetron can also block sodium channels. This effect is similar to that of lidocaine.
OBJECTIVE
The primary outcome was the efficacy of ondansetron compared to lidocaine and placebo for the reduction of propofol injection pain.
METHOD
This trial was conducted in 240 patients, American Society of Anesthesiologists classification I-III and aged between 18-65 years old, undergoing elective surgery, and having a 20-gauge intravenous catheter at the hand dorsum. Each group of 80 patients received 8 mg. of ondansetron in the O Group, 40 mg. of lidocaine in the L Group and normal saline in the C Group. The study medications were blindly administered to the patients through a 20-gauge intravenous catheter placed on the hand dorsum, and then 1 min later, the small dose of propofol (50 mg.) was infused via the syringe pump at a rate of 600 ml/hr. for 30 s. Following that, the syringe pump of propofol was temporarily stopped, and the patients were asked to rate their pain at the injection site.
RESULT
The incidence of pain was lowest in the L group (66.2%) compared with the O (82.5%) and the C groups (85.0%) (P < 0.01). The median pain score in the L, O, and C groups were 2 (0-4), 4 (2-5), and 4.5 (2-6), respectively (P < 0.01). The incidences of no pain, mild, moderate, and severe pain were also significantly different in the L group (33.8%, 37.5%, 21.2%, and 7.5%, respectively) compared with those in the O group (17.5%, 31.2%, 31.2%, and 20.0%, respectively) and the C groups (15.0%, 22.5%, 40.0%, and 22.5%, respectively) (P < 0.01).
CONCLUSION
Pretreatment with intravenous lidocaine, rather than ondansetron, can reduce the incidence and intensity of propofol-induced pain.
Topics: Adolescent; Adult; Aged; Anesthetics, Intravenous; Anesthetics, Local; Double-Blind Method; Humans; Injections, Intravenous; Lidocaine; Middle Aged; Ondansetron; Pain; Pain Measurement; Propofol; Young Adult
PubMed: 35436859
DOI: 10.1186/s12871-022-01650-4 -
Journal of Veterinary Pharmacology and... Nov 2022The purpose of this study was to evaluate the pharmacokinetics of intravenous (IV) ondansetron in a population of hospitalized dogs exhibiting clinical signs of nausea....
The purpose of this study was to evaluate the pharmacokinetics of intravenous (IV) ondansetron in a population of hospitalized dogs exhibiting clinical signs of nausea. The causes of nausea included pancreatitis, gastroenteritis, endocarditis, chemotherapy-induced nausea, diabetes mellitus and ketoacidosis, acute kidney injury with aspiration pneumonia, pyometra, uroabdomen, neoplasia, and hepatopathy. Twenty-four dogs were randomly assigned to one of the following IV ondansetron protocols: 1 mg/kg q12h, 0.5 mg/kg q12h, 1 mg/kg q8h, 0.5 mg/kg q8h. Serum was collected at 0, 0.25, 0.5, 1, 2, 4, 8, 16, and 24 h after the first dose, and nausea scores were recorded at multiple time points. Ondansetron and arginine vasopressin (AVP) concentrations were measured via high-performance liquid chromatography coupled to tandem mass spectrometry and ELISA, respectively. Noncompartmental pharmacokinetic modeling and dose interval modeling were performed. Ondansetron displayed linear pharmacokinetics. In the 0.5 mg/kg group, mean C = 214 ng/ml, AUC = 463 ng/ml*h, and calculated half-life was 1.9 h. In the 1 mg/kg group, mean C = 541 ng/ml, AUC = 1057 ng/ml*h and calculated half-life was 1.6 h. Serum ondansetron concentrations were not significantly different between dogs that required rescue anti-nausea medication (non-responders) and dogs that did not require rescue therapy (responders). In total, 83.3% of patients in the 0.5 mg/kg q8h, 0.5 mg/kg q12h, and 1 mg/kg q8h groups had improvement in nausea scores. In total, 66.7% of patients in the 1 mg/kg q12h group had improvement in nausea scores. In total, 33% of patients had resolution of nausea in the 0.5 mg/kg q8h, 1 mg/kg q8h, and 1 mg/kg q12h groups, and 16% of patients had resolution of nausea in the 0.5 mg/kg q12h group. AVP concentrations were highly variable and did not correlate with nausea scores. Nausea scores significantly decreased regardless of dosage protocol. AVP was not a reliable biomarker of nausea in this group of dogs.
Topics: Dogs; Animals; Ondansetron; Antiemetics; Nausea; Half-Life; Area Under Curve; Double-Blind Method
PubMed: 35899472
DOI: 10.1111/jvp.13087 -
The Cochrane Database of Systematic... Sep 2011Vomiting is a common manifestation of acute gastroenteritis in children and adolescents. When untreated it can be a hindrance to oral rehydration therapy, which is the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Vomiting is a common manifestation of acute gastroenteritis in children and adolescents. When untreated it can be a hindrance to oral rehydration therapy, which is the cornerstone in the management of acute gastroenteritis. Evidence is needed concerning the safety and efficacy of antiemetic use for vomiting in acute gastroenteritis in children.
OBJECTIVES
To assess the safety and effectiveness of antiemetics on gastroenteritis induced vomiting in children and adolescents.
SEARCH STRATEGY
We searched the Cochrane Upper Gastrointestinal and Pancreatic Diseases Group Trials Register comprising references identified from comprehensive electronic database searches and hand searches of relevant journals and abstract books of conferences.The search was re-run and is up to date as on 20 July 2010.
SELECTION CRITERIA
Randomized controlled trials comparing antiemetics with placebo or no treatment, in children and adolescents under the age of 18, for vomiting due to gastroenteritis.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality and extracted data.
MAIN RESULTS
We included seven trials involving 1,020 participants. Mean time to cessation of vomiting in one study was 0.34 days less with dimenhydrinate suppository compared to placebo (P value = 0.036). Pooled data from three studies comparing oral ondansetron with placebo showed: a reduction in the immediate hospital admission rate (RR 0.40, NNT 17, 95% CI 10 to 100) but no difference between the hospitalization rates at 72 hours after discharge from the Emergency Department (ED); a reduction in IV rehydration rates both during the ED stay (RR 0.41, NNT 5, 95% CI 4 to 8), and in follow-up to 72 hours after discharge from the ED stay (worst-best scenario for ondansetron RR 0.57, NNT 6, 95% CI 4 to 13) and an increase in the proportion of patients with cessation of vomiting (RR 1.34, NNT 5, 95% CI 3 to 7)). No significant difference was noted in the revisit rates or adverse events, although diarrhea was reported as a side effect in four of the five ondansetron studies. In one study the proportion of patients with cessation of vomiting in 24 hours was (58%) with IV ondansetron, (17%) placebo and (33%) in the metoclopramide group (P value = 0.039).
AUTHORS' CONCLUSIONS
Oral ondansetron increased the proportion of patients who had ceased vomiting and reduced the number needing intravenous rehydration and immediate hospital admission. Intravenous ondansetron and metoclopramide reduced the number of episodes of vomiting and hospital admission, and dimenhydrinate as a suppository reduced the duration of vomiting.
Topics: Acute Disease; Adolescent; Antiemetics; Child; Child, Preschool; Fluid Therapy; Gastroenteritis; Hospitalization; Humans; Metoclopramide; Ondansetron; Randomized Controlled Trials as Topic; Vomiting
PubMed: 21901699
DOI: 10.1002/14651858.CD005506.pub5 -
British Journal of Anaesthesia Nov 1999We have performed a prospective, randomized, double-blind clinical study to assess the efficacy of ondansetron, droperidol, or both, in preventing postoperative emesis.... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
We have performed a prospective, randomized, double-blind clinical study to assess the efficacy of ondansetron, droperidol, or both, in preventing postoperative emesis. We studied 242 patients undergoing biliary or gynaecological surgery under general anaesthesia. Shortly before induction of anaesthesia, patients received: saline i.v. (group I, n = 62); droperidol 2.5 mg i.v. (group 2, n = 60); ondansetron 4 mg i.v. (group 3, n = 57); or droperidol 2.5 mg with ondansetron 4 mg i.v. (group 4, n = 63). Nausea occurred in 45%, 37%, 32% and 29% (P = 0.234) and vomiting in 23%, 17%, 9% and 5% (P = 0.016) of patients in groups 1, 2, 3 and 4, respectively, during the first 24 h. Groups 2 and 4 had greater sedation scores than group 1 during the first 3 h (P < 0.01). We conclude that both droperidol and ondansetron showed a significant antiemetic effect, ondansetron was not significantly better than droperidol, and the combination of droperidol and ondansetron was better than droperidol but no better than ondansetron alone.
Topics: Adolescent; Adult; Anesthesia, General; Antiemetics; Biliary Tract Surgical Procedures; Double-Blind Method; Droperidol; Drug Combinations; Female; Gynecologic Surgical Procedures; Humans; Male; Middle Aged; Ondansetron; Postoperative Nausea and Vomiting; Prospective Studies
PubMed: 10690150
DOI: 10.1093/bja/83.5.813 -
Clinical Pharmacology and Therapeutics May 2022Ondansetron is commonly used in breastfeeding mothers to treat nausea and vomiting. There is limited information in humans regarding safety of ondansetron exposure to...
Ondansetron is commonly used in breastfeeding mothers to treat nausea and vomiting. There is limited information in humans regarding safety of ondansetron exposure to nursing infants and no adequate study looking at ondansetron pharmacokinetics during lactation. We developed a generic physiologically-based pharmacokinetic lactation model for small molecule drugs and applied this model to predict ondansetron transfer into breast milk and characterize infant exposure. Drug-specific model inputs were parameterized using data from the literature. Population-specific inputs were derived from a previously conducted systematic literature review of anatomic and physiologic changes in postpartum women. Model predictions were evaluated using ondansetron plasma and breast milk concentration data collected prospectively from 78 women in the Commonly Used Drugs During Lactation and infant Exposure (CUDDLE) study. The final model predicted breast milk and plasma exposures following a single 4 mg dose of intravenous ondansetron in 1,000 simulated women who were 2 days postpartum. Model predictions showed good agreement with observed data. Breast milk median prediction error (MPE) was 18.4% and median absolute prediction error (MAPE) was 53.0%. Plasma MPE was 32.5% and MAPE was 43.2%. The model-predicted daily and relative infant doses were 0.005 mg/kg/day and 3.0%, respectively. This model adequately predicted ondansetron passage into breast milk. The calculated low relative infant dose indicates that mothers receiving ondansetron can safely breastfeed. The model building blocks and population database are open-source and can be adapted to other drugs.
Topics: Female; Humans; Infant; Breast Feeding; Lactation; Milk, Human; Ondansetron; Postpartum Period
PubMed: 35076931
DOI: 10.1002/cpt.2530 -
Pharmacological Reports : PR Feb 2023Cisplatin is considered one of the most effective and commonly used chemotherapeutic drugs, but despite its high therapeutic effectiveness, most patients treated with...
BACKGROUND
Cisplatin is considered one of the most effective and commonly used chemotherapeutic drugs, but despite its high therapeutic effectiveness, most patients treated with cisplatin suffer from nausea and vomiting, neurotoxic side effects, and cerebral psychiatric disorders such as depression. Therefore, the aim of the current work was to explore whether a selective 5-HT receptor antagonist (Ondansetron) administered via the oral route or intranasally in microemulsion form would alleviate cisplatin's adverse effects.
METHODS
The selected ondansetron microemulsion was characterized in vitro for particle size, polydispersity, zeta potential, morphology, and nasal permeation, and in vivo in terms of anti-emetic and antidepressant activity, with the assessment of biochemical markers in brain homogenates.
RESULTS
Results revealed that both orally administered ondansetron and intranasally administered microemulsion were able to counteract the pica effect by increasing food consumption, water intake, and decreasing kaolin intake. They were also able to increase BDNF, normalize IL-6, increase serotonin, and normalize NOx, MDA, GSSH/GSH as well as 8OHdG levels in rats' brain homogenates. The intranasal ondansetron microemulsion displayed superiority compared to oral conventional ondansetron in terms of increasing food intake, reduction of stomach content, and normalization of serotonin turnover.
CONCLUSION
Ondansetron microemulsion can be administered by an alternative route of administration (intranasal) rather than oral, for patients on cisplatin chemotherapy.
Topics: Rats; Animals; Ondansetron; Cisplatin; Serotonin; Antiemetics; Vomiting; Drug-Related Side Effects and Adverse Reactions
PubMed: 36517694
DOI: 10.1007/s43440-022-00435-3 -
Gut Jul 2015
Topics: Diarrhea; Female; Humans; Irritable Bowel Syndrome; Male; Ondansetron; Serotonin Antagonists
PubMed: 24846912
DOI: 10.1136/gutjnl-2014-307551 -
Clinical and Translational Science Feb 2023The goal of this study was to determine whether CYP2D6 metabolizer status within the ondansetron-treated pediatric tonsillectomy population is associated with risk of...
The goal of this study was to determine whether CYP2D6 metabolizer status within the ondansetron-treated pediatric tonsillectomy population is associated with risk of postoperative nausea and vomiting (PONV) in the post-anesthesia care unit. We conducted a retrospective cohort study of pediatric patients (<18 years) who underwent tonsillectomy and received ondansetron on the day of the procedure. Data were obtained from BioVU, an institutional biobank that links DNA to de-identified electronic health record data. Subjects were tested for 10 CYP2D6 allelic variants and copy number variation, and genotype data translated into CYP2D6 metabolizer status. The cohort included 652 individuals, 105 (16.1%) of whom had PONV. Rates of PONV were similar across groups: ultrarapid metabolizers (UMs), 1 of 9 (11.1%); normal metabolizers (NMs), 64 of 354 (18.1%); intermediate metabolizers (IMs), 33 of 234 (14.1%); poor metabolizers (PMs), 6 of 39 (15.4%); and ambiguous phenotypes, 1 of 16 (6.3%). In multivariable analysis adjusted for age, sex, and time under anesthesia, CYP2D6 metabolizer status was not associated with PONV, with an odds ratio of 1.37 (95% confidence interval 0.9, 2.1) when comparing PM/IM versus NM/UM. In this large pediatric population, no significant differences were detected for PONV based on CYP2D6 metabolizer status. Further investigation is needed to determine mechanisms for ondansetron inefficacy in children.
Topics: Child; Humans; Ondansetron; Cytochrome P-450 CYP2D6; Postoperative Nausea and Vomiting; DNA Copy Number Variations; Retrospective Studies; Tonsillectomy
PubMed: 36350309
DOI: 10.1111/cts.13447 -
Journal of Veterinary Internal Medicine Sep 2022Nausea and emesis can be, among other signs, common manifestations of acute vestibular system dysfunction in dogs. Currently, antiemetic drugs, such as maropitant and...
BACKGROUND
Nausea and emesis can be, among other signs, common manifestations of acute vestibular system dysfunction in dogs. Currently, antiemetic drugs, such as maropitant and metoclopramide, are used commonly, but do not appear to control nausea. A non-placebo-controlled preliminary study suggested good efficacy of 5-HT3-receptor antagonists, such as ondansetron, against nausea in dogs with vestibular syndrome.
OBJECTIVES
To assess and confirm the effect of ondansetron on behavior suggestive of nausea in dogs with vestibular syndrome.
ANIMALS
Fourteen dogs with vestibular syndrome and clinical signs of nausea presented to a neurology service.
METHODS
Placebo-controlled, double-blinded, crossover study. Behavioral assessment was performed hourly for 4 hours using an established numerical rating scale. The criteria salivation, lip licking, vocalization, restlessness, lethargy, and general nausea were scored. The occurrence of emesis was recorded. After scoring at T0 (pre-dose) and T2 (2 hours post-dose) either ondansetron (0.5 mg/kg) or placebo was injected IV. Two hours post-dose, treatments were switched. Blood samples were collected to measure serum arginine vasopressin (AVP) concentration, which previously has been shown to correlate with clinical signs of nausea.
RESULTS
Clinical resolution of nausea was observed 1 hour after administration of ondansetron, whereas serum AVP concentration decreased 4 hours after ondansetron administration.
CONCLUSION AND CLINICAL IMPORTANCE
Administration of ondansetron IV is beneficial for dogs with nausea secondary to acute vestibular syndrome. Ondansetron substantially and rapidly decreased clinical signs of nausea behavior and stopped emesis.
Topics: Animals; Antiemetics; Arginine Vasopressin; Cross-Over Studies; Dog Diseases; Dogs; Double-Blind Method; Metoclopramide; Nausea; Ondansetron; Vestibular Diseases; Vomiting
PubMed: 35906792
DOI: 10.1111/jvim.16504 -
International Journal of Surgery... Nov 2016Considerable controversy exists regarding the efficacy of ondansetron in preventing postanesthesia shivering (PAS). We performed a meta-analysis of randomized controlled... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
Considerable controversy exists regarding the efficacy of ondansetron in preventing postanesthesia shivering (PAS). We performed a meta-analysis of randomized controlled trials to examine the controversy.
MATERIALS AND METHODS
Randomized controlled trials assessing the effect of ondansetron on the prevention of PAS were identified from electronic databases (PubMed and EMBASE). The meta-analysis was performed with the fixed-effect model or random-effect model according to heterogeneity.
RESULTS
Twelve trials randomized clinical trials met the inclusion criteria including 1205 subjects. Compared with placebo (saline), ondansetron was associated with a significant reduction of PAS (relative risk 0.33; 95% confidence interval, 0.21-0.51), Substantial heterogeneity was observed between trials (P = 0.0002; I = 71%). Trial sequential analysis showed that the cumulative Z-curve crossed the trial sequential monitoring boundary for benefit establishing sufficient and conclusive evidence. Meta-analysis with all five studies using a fixed-effects model suggested that ondansetron and meperidine have similar effects on the prevention of PAS (relative risk, 0.86; 95% confidence interval, 0.66-1.11), the heterogeneity was not significant (P = 0.34; I = 11%). No significant association of ondansetron with bradycardia was found both comparison with placebo and meperidine.
CONCLUSIONS
Treat with ondansetron is safe, and may reduce PAS. This finding encourages the use of ondansetron to prevent PAS, but, more high quality randomized clinical trials are still warranted to confirm the effects of different doses of ondansetron on PAS.
Topics: Anesthesia; Humans; Ondansetron; Randomized Controlled Trials as Topic; Serotonin Antagonists; Shivering
PubMed: 27632391
DOI: 10.1016/j.ijsu.2016.09.009