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BioMed Research International 2022The study was aimed at designing and characterizing the ondansetron hydrochloride (OND) bearing agarose (AG), and hydroxypropyl methyl cellulose (HPMC) mucoadhesive...
The study was aimed at designing and characterizing the ondansetron hydrochloride (OND) bearing agarose (AG), and hydroxypropyl methyl cellulose (HPMC) mucoadhesive buccal films employing glycerol as a plasticizer. The buccal delivery of ondansetron hydrochloride was remarkably boosted by employing physical (iontophoresis) and chemical enhancement approaches (chemical penetration enhancers). To explore the influence of different formulation components, i.e., agarose, hydroxypropyl methyl cellulose (HPMC), and glycerol on various evaluating parameters, i.e., tensile strength, swelling index, ex vivo mucoadhesion time, and subsequently on in vitro drug release, a D-optimal design was opted. A buccal film bearing OND was mounted on bovine buccal mucosa for ex vivo permeation studies and impact of chemical and physical enhancement techniques on the permeation profile was also analysed. A linear release profile was revealed in in vitro drug release of OND over 60 minutes and outcomes ascertained the direct relationship between HPMC content and in vitro drug release and inverse relationship was depicted by AG content. The FTIR and DSC thermal analysis was executed to determine the physicochemical interactions and results exposed no chemical interactions between drug and polymers. The drug (OND) appeared as tiny crystals on smooth film surface during scanning electron microscopy (SEM) analysis. A notable enhancement in permeation flux, i.e., 761.02 g/min of OND during ex vivo permeation studies was witnessed after the application of current (0.5-1 mA) without any time lag and with enhancement ratio of 3.107. A time lag of 15 minutes, 19 minutes, and 26 minutes with permeation flux of 475.34 g/min, 399.35 g/min, and 244.81 g/min was observed after chemical enhancer pretreatment with propylene glycol, Tween 80, and passive, respectively. Rabbit was employed as the experimental animal for pharmacokinetic studies (in vivo) and cats for pharmacological activity (in vivo), and the results illustrated the enhanced bioavailablity (2.88 times) in the iontophoresis animal group when compared with the rabbits of control group. Likewise, a remarkable reduction in emesis events was recorded in cats of iontophoresis group. Conclusively, the histopathological examinations on excised buccal mucosa unveiled no severe necrotic or cytopathetic outcomes of current.
Topics: Animals; Cats; Cattle; Drug Delivery Systems; Glycerol; Hypromellose Derivatives; Iontophoresis; Methylcellulose; Mouth Mucosa; Ondansetron; Rabbits; Sepharose
PubMed: 35372569
DOI: 10.1155/2022/1662194 -
Brazilian Journal of Anesthesiology... 2024End-stage renal diseases patients have a high risk of postoperative nausea and vomiting (PONV), which is multifactorial and need acute attention after renal... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
End-stage renal diseases patients have a high risk of postoperative nausea and vomiting (PONV), which is multifactorial and need acute attention after renal transplantation for a successful outcome in term of an uneventful postoperative period. The study was done to compare the efficacy of palonosetron and ondansetron in preventing early and late-onset PONV in live donor renal transplantation recipients (LDRT).
METHODS
The prospective randomized double-blinded study was done on 112 consecutive patients planned for live donor renal transplantation. Patients of both sexes in the age group of 18...60 years were randomly divided into two groups: Group O (Ondansetron) and Group P (Palonosetron) with 56 patients in each group by computer-generated randomization. The study drug was administered intravenously (IV) slowly over 30.ßseconds, one hour before extubation. Postoperatively, the patients were accessed for PONV at 6, 24, and 72.ßhours using the Visual Analogue Scale (VAS) nausea score and PONV intensity scale.
RESULTS
The incidence of PONV in the study was found to be 30.35%. There was significant difference in incidence of PONV between Group P and Group O at 6.ßhours (12.5% vs. 32.1%, p.ß=.ß0.013) and 72.ßhours (1.8% vs. 33.9%, p.ß<.ß0.001), but insignificant difference at 24.ßhours (1.8% vs. 10.7%, p.ß=.ß0.113). VAS-nausea score was significantly lower in Group P as compared to Group O at a time point of 24.ßhours (45.54.ß...ß12.64 vs. 51.96.ß...ß14.70, p.ß=.ß0.015) and 72.ßhours (39.11.ß...ß10.32 vs. 45.7.ß...ß15.12, p.ß=.ß0.015).
CONCLUSION
Palonosetron is clinically superior to ondansetron in preventing early and delayed onset postoperative nausea and vomiting in live-related renal transplant recipients.
Topics: Male; Female; Humans; Adolescent; Palonosetron; Ondansetron; Postoperative Nausea and Vomiting; Antiemetics; Kidney Transplantation; Prospective Studies; Double-Blind Method
PubMed: 34411635
DOI: 10.1016/j.bjane.2021.07.027 -
Anesthesiology Feb 1999
Topics: Anesthesia; Antiemetics; Granisetron; Humans; Indoles; Ondansetron; Postoperative Nausea and Vomiting; Quinolizines
PubMed: 9952135
DOI: 10.1097/00000542-199902000-00003 -
Pediatric Emergency Care Apr 2018Guidelines recommend oral rehydration therapy (ORT) and avoidance of laboratory tests and intravenous fluids for mild to moderate dehydration in children with...
BACKGROUND
Guidelines recommend oral rehydration therapy (ORT) and avoidance of laboratory tests and intravenous fluids for mild to moderate dehydration in children with gastroenteritis; oral ondansetron has been shown to be an effective adjunct.
OBJECTIVES
The aim of this study was to determine if a triage-based, nurse-initiated protocol for early provision of ondansetron and ORT could safely improve the care of pediatric emergency department (ED) patients with symptoms of gastroenteritis.
METHODS
This study evaluated a protocol prompting triage nurses to assess dehydration in gastroenteritis patients and initiate ondansetron and ORT if indicated. Otherwise well patients aged 6 months to 5 years with symptoms of gastroenteritis were eligible. Prospective postintervention data were compared with retrospective, preintervention control subjects.
RESULTS
One hundred twenty-eight (81 postintervention and 47 preintervention) patients were analyzed; average age was 2.1 years. Ondansetron use increased from 36% to 75% (P < 0.001). Time to ondansetron decreased from 60 minutes to 30 minutes (P = 0.004). Documented ORT increased from 51% to 100% (P < 0.001). Blood testing decreased from 37% to 21% (P = 0.007); intravenous fluid decreased from 23% to 9% (P = 0.03). Fifty-two percent of postintervention patients were discharged with prescriptions for ondansetron. There were no significant changes in ED length of stay, admissions, or unscheduled return to care.
CONCLUSIONS
A triage nurse-initiated protocol for early use of oral ondansetron and ORT in children with evidence of gastroenteritis is associated with increased and earlier use of ondansetron and ORT and decreased use of IV fluids and blood testing without lengthening ED stays or increasing rates of admission or unscheduled return to care.
Topics: Antiemetics; Child, Preschool; Critical Pathways; Dehydration; Emergency Service, Hospital; Female; Fluid Therapy; Gastroenteritis; Hospitalization; Humans; Infant; Length of Stay; Male; Ondansetron; Prospective Studies; Retrospective Studies; Triage
PubMed: 28277412
DOI: 10.1097/PEC.0000000000001070 -
British Journal of Anaesthesia Mar 1996This study has compared the incidences of nausea, vomiting and headache after ondansetron 0.06 mg kg-1 i.v., prochlorperazine 0.2 mg kg-1 i.m. and prochlorperazine 0.1... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
This study has compared the incidences of nausea, vomiting and headache after ondansetron 0.06 mg kg-1 i.v., prochlorperazine 0.2 mg kg-1 i.m. and prochlorperazine 0.1 mg kg-1 i.v. given during induction of general anaesthesia to 282 patients undergoing adenotonsillectomy. The cardiovascular effects of the drugs were similar. After operation, nausea per se and vomiting per se occurred with similar frequency, in between 6% and 11% and 11% and 19%, respectively, in each test group. Nausea and vomiting in the same patient was reduced from 29% to 2% by i.v. ondansetron (P < 0.0005) and to 3% by i.m. prochlorperazine (P < 0.0005), and appeared to be less severe in these groups. Headache was most frequent after i.v. ondansetron (35%: P < 0.05), but occurred with similar frequency after i.m. prochlorperazine (32%) and i.v. prochlorperazine (29%).
Topics: Adenoidectomy; Adolescent; Adult; Aged; Antiemetics; Child; Child, Preschool; Double-Blind Method; Female; Humans; Injections, Intramuscular; Injections, Intravenous; Male; Middle Aged; Nausea; Ondansetron; Postoperative Complications; Prochlorperazine; Tonsillectomy; Vomiting
PubMed: 8785149
DOI: 10.1093/bja/76.3.449 -
British Journal of Anaesthesia Oct 1999We have compared ondansetron 4 mg i.v. and cyclizine 50 mg i.v., in a double-blind, randomized, placebo-controlled study for the prevention of postoperative nausea and... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
We have compared ondansetron 4 mg i.v. and cyclizine 50 mg i.v., in a double-blind, randomized, placebo-controlled study for the prevention of postoperative nausea and vomiting (PONV) for 24 h after day-case gynaecological laparoscopy. Compared with placebo (n = 58), ondansetron (n = 60) and cyclizine (n = 57) reduced significantly the incidence of moderate or severe nausea (30% and 23% vs 52%; P = 0.02 and P = 0.001, respectively) and requirement for escape antiemetic (28% and 16% vs 47%; P = 0.04 and P < 0.001, respectively) before discharge from hospital. There were no significant differences in PONV after discharge. Significantly more patients suffered no PONV before and after discharge after ondansetron and cyclizine compared with placebo (31% and 33% vs 12%; P = 0.02 and P < 0.01, respectively). For diagnostic laparoscopy (n = 74), fewer patients received escape antiemetic after cyclizine than after ondansetron (4% vs 37%; P < 0.01); for laparoscopic sterilization (n = 101), both antiemetics were equally effective. Ondansetron and cyclizine both reduced severe and moderate nausea and the need for antiemetic therapy after day-case gynaecological laparoscopy.
Topics: Adult; Ambulatory Surgical Procedures; Analysis of Variance; Antiemetics; Cyclizine; Double-Blind Method; Female; Histamine H1 Antagonists; Humans; Laparoscopy; Middle Aged; Ondansetron; Postoperative Nausea and Vomiting; Serotonin Antagonists
PubMed: 10673879
DOI: 10.1093/bja/83.4.611 -
Scientific Reports Aug 2022Monosodium glutamate induces behaviors thought to reflect headache and nausea in rats. We explored the effects of the N-methyl-D-aspartate receptor antagonist...
Monosodium glutamate induces behaviors thought to reflect headache and nausea in rats. We explored the effects of the N-methyl-D-aspartate receptor antagonist (2R)-amino-5-phosphonovaleric acid, the inotropic glutamate receptor antagonist kynurenic acid, and the CGRP receptor antagonist olcegepant, on monosodium glutamate-induced increases in nocifensive, headache-like and nausea behaviours. Effects of these antagonists on motor function were examined with a rotarod. The effect of the dopamine receptor antagonist metoclopramide and the serotonin 3 receptor antagonist ondansetron on nausea behaviour was also assessed. (2R)-amino-5-phosphonovaleric acid, and to a lesser extent, kynurenic acid and olcegepant, reduced nocifensive and headache-like behaviours evoked by monosodium glutamate. No alteration in motor function by (2R)-amino-5-phosphonovaleric acid, kynurenic acid or olcegepant was observed. No sex-related differences in the effectiveness of these agents were identified. Nausea behaviour was significantly more pronounced in male than in female rats. Olcegepant, ondansetron and metoclopramide ameliorated this nausea behaviour in male rats. Ondansetron and metoclopramide also reduced headache-like behaviour in male rats. These findings suggest that peripheral N-methyl-D-aspartate receptor activation underlies monosodium glutamate-induced headache-like behaviour but does not mediate the nausea behaviour in rats.
Topics: Amino Acids; Animals; Aspartic Acid; Female; Glutamic Acid; Headache; Kynurenic Acid; Male; Metoclopramide; Nausea; Ondansetron; Rats; Receptors, N-Methyl-D-Aspartate; Sodium Glutamate
PubMed: 35974090
DOI: 10.1038/s41598-022-18290-w -
International Journal of Surgery... Sep 2019Different categories of drugs are used to reduce the incidence of post-operative nausea and vomiting (PONV) following laparoscopic cholecystectomy (LC). This study is a... (Review)
Review
Drugs for preventing post-operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: Network meta-analysis of randomized clinical trials and trial sequential analysis.
BACKGROUND
Different categories of drugs are used to reduce the incidence of post-operative nausea and vomiting (PONV) following laparoscopic cholecystectomy (LC). This study is a network meta-analysis of randomized clinical trials with such drugs.
METHODS
Electronic databases were searched for appropriate randomized clinical trials evaluating drugs reducing PONV in LC. Number of patients without PONV at 24 h was the primary outcome; and incidence of nausea and/or vomiting at 6 h and 24 h, and adverse events were the secondary outcome measures. Risk of bias was evaluated for each study. Mixed treatment comparison estimates were derived by random-effects modelling. Trial sequential analysis was carried out to assess the adequacy of evidence; and surface area under cumulative ranking curve was generated to identify the best intervention in the pool. Grading of the evidence for key comparisons was done.
RESULTS
Ninety clinical trials were included. Metoclopramide, gabapentin, dixyrazine, ondansetron, granisetron, dexamethasone, tropisetron, droperidol, droperidol/dexamethasone, droperidol/metoclopramide, granisetron/droperidol and granisetron/dexamethasone, haloperidol, dexmedetomidine, palonosetron, droperidol/ondansetron, metoclopramide/dexamethasone, haloperidol/ondansetron, haloperidol/dexamethasone, palonosetron/dexamethasone and ramosetron/dexamethasone were observed with significant benefits compared to placebo. Corticosteroid/serotonin receptor antagonists was observed with the highest probability of being the 'best' in this pool. However, the moderate quality of evidence obtained was adequate to confirm the benefits of dexamethasone and ondansetron only.
CONCLUSION
The relative effect sizes for various prophylactic anti-emetics for LC was modelled using the principles of network meta-analysis. Dexamethasone and ondansetron have the best evidence as stand-alone options and the combination is preferred in high-risk category. Caution should be exercised while interpreting the evidence as the estimates might change with head-to-head clinical trial data.
Topics: Antiemetics; Cholecystectomy, Laparoscopic; Dexamethasone; Drug Therapy, Combination; Humans; Network Meta-Analysis; Ondansetron; Postoperative Nausea and Vomiting; Randomized Controlled Trials as Topic
PubMed: 31299429
DOI: 10.1016/j.ijsu.2019.07.002 -
Journal of Perinatology : Official... Mar 2023To determine if treatment with a 5-HT3 antagonist (ondansetron) reduces need for opioid therapy in infants at risk for neonatal opioid withdrawal syndrome (NOWS). (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To determine if treatment with a 5-HT3 antagonist (ondansetron) reduces need for opioid therapy in infants at risk for neonatal opioid withdrawal syndrome (NOWS).
STUDY DESIGN
A multicenter, randomized, placebo controlled, double blind clinical trial of ninety (90) infants. The intervention arms were intravenous ondansetron or placebo during labor followed by a daily dose of ondansetron or placebo in infants for five days.
RESULTS
Twenty-two (49%) ondansetron-treated and 26 (63%) placebo-treated infants required pharmacologic treatment (p > 0.05). The Finnegan score was lower in the ondansetron-treated group (4.6 vs. 5.6, p = 0.02). A non-significant trend was noted for the duration of hospitalization. There was no difference in need for phenobarbital or clonidine therapy, or total dose of morphine in the first 15 days of NOWS treatment.
CONCLUSIONS
Ondansetron treatment reduced the severity of NOWS symptoms; and there was an indication that it could reduce the length of stay.
CLINICAL TRIAL REGISTRATION
Clinicaltrials.gov NCT01965704.
Topics: Infant, Newborn; Humans; Analgesics, Opioid; Ondansetron; Morphine; Neonatal Abstinence Syndrome; Phenobarbital
PubMed: 36030327
DOI: 10.1038/s41372-022-01487-2 -
Pain Physician Jan 2023Postoperative nausea and vomiting (PONV) are common unpleasant adverse effects after surgery. The incidence of PONV in pediatric patients is often twice as high as in... (Randomized Controlled Trial)
Randomized Controlled Trial
Effect of Dexmedetomidine, Dexamethasone, and Ondansetron on Postoperative Nausea and Vomiting in Children Undergoing Dental Rehabilitation: A Randomized Controlled Trial.
BACKGROUND
Postoperative nausea and vomiting (PONV) are common unpleasant adverse effects after surgery. The incidence of PONV in pediatric patients is often twice as high as in adults.
OBJECTIVES
This study aimed to evaluate the effects of dexmedetomidine, dexamethasone, and ondansetron for preventing PONV in children undergoing dental rehabilitation surgery.
STUDY DESIGN
A prospective, randomized controlled clinical trial.
SETTING
Sharurah Armed Forces Hospital, Ministry of Defense Medical Services, Saudi Arabia.
METHODS
One hundred patients (6-12 years old) scheduled for dental rehabilitation were included. Patients were randomly allocated into 4 groups (25 each) to receive either 0.15 mg/kg dexamethasone (DEX), 0.05 mg/kg ondansetron (OND), 0.3 microgram/kg dexmedetomidine (DEXMED), or normal saline (control[CONT]) in DEX, OND, DEXMED or CONT groups, respectively, via infusion after induction of anesthesia. The primary outcome was a PONV incident in the first 24 hours. Secondary outcomes were: granisetron doses during 24 hours postoperative, Paediatric Anaesthesia Emergence Delirium (PAED) scale, Pediatric Objective Pain Scale (POPS) for 4 hours postoperatively, and complications in the first 24 hours.
RESULTS
The reduction of PONV and the overall number of patients who developed PONV was statistically significant in the DEXMED group compared to the CONT group (P = 0.041). However, the DEXMED group was higher compared to the DEX and OND groups but not statistically significant. Granisetron requirements and doses were statistically significantly lower in the DEXMED group than in the CONT group. PAED and POPS scores were much better in the DEXMED group than in the other groups with a statistically significant difference in most of the time measurements.
LIMITATION
Optimal dexmedetomidine dose for better effect on PONV without affecting hemodynamic stability requires more studies.
CONCLUSION
Dexmedetomidine is effective in reducing PONV in children undergoing dental rehabilitation with better sedative and analgesic scores as compared to the control group.
Topics: Adult; Humans; Child; Ondansetron; Postoperative Nausea and Vomiting; Antiemetics; Dexmedetomidine; Granisetron; Prospective Studies; Dexamethasone; Double-Blind Method
PubMed: 36791288
DOI: No ID Found