CONTROL OF POST-SURGICAL PAIN

Introduction: There are many complications for patients with post cesarean section relative pain. So it delays in discharging or increasing in hospital stay. The objective of this study was a comparison between Tramadol and Meperidine according to pain relief or other possible complications in post cesarean section pain control. Materials and Methods: This study was a double blind clinical trial. It arranged for 240 parturients who scheduled for emergency cesarean section with pain after surgery in spite of spinal anesthesia. All patients were in ASA class I. They were divided randomly in two groups .Meperidine (M) and Tramadol (T) groups with 120 patients in each group. After beginning of pain in post anesthesia care unit (VAS> or = 4), in group (T) tramadol 1.5 mg/kg and in group (M) meperidine .5 mg/kg were injected intravenously. Apart from pain, other drug complications such as shivering, blood pressure changes, itching, nausea and vomiting, drowsiness were recorded one and two hours after injection. Data were analyzed by chi-square test. Results: Relative frequency rate (RFR) of 50% decrease in pain score one hour after intravenous injection was 56.7% in group (T) and 69.2% in group (M) ( P = 0.054). RFR for respiratory depression after one hour was 5.8% in (M) group and 0 in (T) group (P = 0.007). RFR for nausea after one hour was 39.2% in (T) group and 23.3% in (M) group (P = 0.008). RFR for vomiting after one hour was 23.3% in (T) group and 13.3% in (M) group (P= 0.045). RFR for drowsiness after one hour was 25% in (M) group and 3.3% in (T) group (P=0.007). There was no statistically significant relationship after 2nd hour for pain relief, nausea, vomiting and drowsiness between two groups. There was no difference between two groups in RFR for shivering, blood pressurechanges and itching in both two groups. Conclusion: This study illustrates both remedies Meperidine and Tramadol which were effective for pain relief and shivering after cesarean section. But according to high incidence of nausea and vomiting with Tramadol and more analgesic effects of Meperidine than Tramadol, administration of Meperidine is better than Tramadol after cesarean section for pain control.

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Comparing the Effects of Cumin, Peppermint, and Milk of Magnesia on Gastrointestinal Complications after Caesarean Section

Global Journal of Health Science ◽

10.5539/gjhs.v8n12p78 ◽

2016 ◽

Vol 8 (12) ◽

pp. 78 ◽

Cited By ~ 1

Author(s):

Maryam Tofighi Niaki ◽

Zoleykha Atarod ◽

Shabnam Omidvar ◽

Mandana Zafari ◽

Azar Aghamohammadi ◽

...

Keyword(s):

Caesarean Section ◽

Cesarean Section ◽

Controlled Trial ◽

Chi Square ◽

Double Blind ◽

Gastrointestinal Complications ◽

Gynecology And Obstetrics ◽

Emergency Cesarean ◽

Gastrointestinal Problems ◽

Significant Difference

CONTEXT: Gastrointestinal problems are common after Cesarean section. During the past three decades, there has been an increasing trend in the use of herbal plants in the treatment of various medical conditions.AIMS: This study aimed to compare the effects of cumin, peppermint with magnesium hydroxide (milk of magnesia; MOM) on gastrointestinal complications of Caesarean section.SETTINGS & DESIGN: This randomized double-blind controlled trial was conducted in the Gynecology and Obstetrics Department of Imam Hospital (affiliated to Mazandaran University of Medical Sciences, Sari, Iran) during November 2013-August 2014. The project was approved by the Research Ethics Committee of Islamic Azad Medical University, Sari Branch (Iran).MATERIAL & METHODS: A total of 83 patients undergoing non-emergency Cesarean delivery in Imam Hospital were randomly selected. Patients with underlying diseases, history of gastrointestinal problems, fever, intestinal adhesion, longer-than-usual Cesarean section, and lack of cooperation were excluded. The subjects were informed about the study objectives and procedure and asked to provide written informed consent. They were then randomly assigned into three groups of cumin, peppermint, MOM. Gastrointestinal complications were assessed 20, 40, 60, and 120 minutes after drug administration.STATISTICAL ANALYSIS USED: The collected data were analyzed using Fisher’s exact and chi-square tests in SPSS for Windows 18.0.RESULTS: There was no significant difference between three groups according to incidence of gastrointestinal side effects after Cesarean section at the mentioned intervals.CONCLUSIONS: Cumin and peppermint were as effective as MOM.

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Outcome of pregnancy in women with previous one cesarean section

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20183327 ◽

2018 ◽

Vol 7 (8) ◽

pp. 3257

Author(s):

Manish Mittal ◽

Meenakshi Kandoria ◽

Rajeev Sood ◽

Monica Chauhan ◽

Rohini Rao ◽

...

Keyword(s):

Cesarean Section ◽

P Value ◽

Perinatal Complications ◽

Chi Square ◽

Emergency Cesarean Section ◽

Emergency Cesarean ◽

Vaginal Deliveries ◽

Mother And Child ◽

Chi Square Test ◽

Gandhi Medical College

Background: Worldwide rise in cesarean section (CS) rate during the last three decades has been the cause of alarm and needs an in-depth study. The purpose of this study was to determine the outcome of pregnancy in women with previous one cesarean section and maternal and perinatal complications. It also aimed at identifying the factors, which can influence the outcome of trial of labour (TOL).Methods: The prospective study was conducted in the department of Obstetrics and Gynaecology, Kamla Nehru hospital for mother and child, Indira Gandhi Medical College, Shimla, from June 2013 to May 2014 which included all women undergoing trial for vaginal birth after a previous cesarean who were more than 34 weeks, singleton viable fetus of appropriate size with cephalic presentation with inter delivery interval more than 18 months. Collected data was analysed by Student T-test and Chi-square test was used where required, for statistical analysis using Epi info 7 software. P value <0.05 was considered significant.Results: Out of 152 subjects given trial of labour, 107 (70.39%) subjects had successful VBAC and 45 (29.61%) had repeat emergency cesarean section. The maternal morbidity in emergency cesarean section group and vaginal delivered group was seen in 14 (31%), 8 (7.47%) subjects respectively. No significant perinatal morbidity was observed. VBAC rate was significantly more in women who had prior vaginal deliveries, especially in those with previous VBAC.Conclusions: In carefully selected cases, trial of labour (TOL) after a prior cesarean is safe and often successful. A prior vaginal delivery, particularly, a prior VBAC are associated with a higher rate of successful TOL.

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Perbandingan Efek Analgesi Infiltrasi Morfin 10 Mg dan Bupivakain 0,5% 2 Mg/KgBB pada Seksio Sesarea dengan Teknik Anestesi Spinal

Jurnal Anestesi Obstetri Indonesia ◽

10.47507/obstetri.v3i2.45 ◽

2020 ◽

Vol 3 (2) ◽

pp. 73-9

Author(s):

Wulan Fadinie ◽

Dadik Wahyu Wijaya ◽

Hasanul Arifin

Keyword(s):

Side Effects ◽

Cesarean Section ◽

Spinal Anesthesia ◽

Subcutaneous Administration ◽

Postoperative Pain Management ◽

Pain Scale ◽

Morphine Group ◽

Chi Square ◽

Analgesic Effects ◽

Emergency Cesarean

Latar Belakang: Persalinan dengan seksio sesarea sangat umum dilakukan dan setiap intervensi yang dapat mengurangi rasa sakit pasca operasi layak diteliti lebih lanjut. Cara terbaik untuk mengurangi rasa sakit dengan memberikan analgesi yang langsung bekerja pada area luka. Telah diketahui morfin memiliki reseptor perifer sehingga pemberian secara subkutan dapat menjadi metode yang sangat efektif dalam manajemen nyeri pasca operasiTujuan: Membandingkan efek analgesi dari infiltrasi lokal morfin 10 mg dengan bupivakain 2mg/kgBB 0,5% pada pasca seksio sesarea dengan anestesi spinal. Subjek dan Metode: Penelitian ini adalah uji klinis acak tersamar ganda dengan 100 sampel wanita hamil, usia 20-40 tahun, PS-ASA I-II yang akan menjalani seksio sesarea elektif dan darurat dengan anestesi spinal. Setelah dihitung secara statistik, sampel dibagi secara acak menjadi 2 kelompok. Kelompok pertama mendapat morfin 10 mg dan kelompok kedua mendapat bupivakain 0,5% 2 mg/kgBB secara infiltrasi lokal subkutan didaerah luka operasi. Skala nyeri dinilai dengan VAS. Hasilnya diuji dengan uji T-independent, Chi-Square, dengan nilai signifikan 95% (p <0,05%, signifikan secara statistik). Hasil: Pada kelompok morfin pemberian analgesi tambahan lebih sedikit daripada kelompok bupivakain, hasilnya berbeda bermakna secara statistik (p <0.05) pada setiap jam pengamatan. Efek samping tidak ditemukan pada kedua kelompok. Kelompok morfin meringankan rasa sakit lebih baik daripada kelompok bupivakain dengan skor VAS yang lebih rendah pada setiap jam pengamatanSimpulan: Infiltrasi lokal subkutan 10 mg morfin memberikan efek analgetik yang lebih baik pada pasien pasca seksio sesarea dengan anestesi spinal dibandingkan dengan bupivacain 0,5% 2 mg/kgBB, tanpa efek samping. Comparison of the Analgesic Effects of 10 mg Morphine and 2mg/BW Bupivacaine 0.5% Infiltration in Cesarean Section with Spinal Anesthesia Technique Abstract Background: Nowadays, deliveries by cesarean section are more commonly done, any intervention that can make progression to reduce post-operative pain are feasible for further study. The best way to reduce pain is by administration pain relieve drug that directly act in wound. It is known that morphine has peripheral receptors, so subcutaneous administration can be a very effective method of postoperative pain management. Objective: To compare analgetic effect from local infiltration of 10 mg morphine with 2mg/BW bupivacaine 0.5% in post cesarean section with spinal anesthesiaSubject and Methods: This study was done by double blinded randomized clinical trial with 100 samples of pregnant women, age 20-40 years, PS-ASA I-II that will undergo elective and emergency cesarean section with spinal anesthesia. After calculated statistically, all samples divided randomly into 2 groups. First group got morphine 10 mg and second group got bupivacaine 0.5% 2 mg/BW infiltration at the area of surgical wound. Pain scale was evaluated by VAS. The result was tested by T-independent test, Chi-Square, with significant value 95% (p<0.05%, statistically significant). Result: In morphine group, the additional analgesia was less than bupivacaine group, the results were statistically significant (p <0.05) at each hour of observation. No side effects were found in either group. The morphine group relieved pain better than the bupivacaine group with lower VAS scores at each hour of observation.Conclusion: Infiltration of 10 mg morphine subcutaneous compared to bupivacaine 0.5% 2mg/BW give better analgetic effect in post cesarean section patients with spinal anesthesia, without any side effects

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Sedative and analgesic effects of propofol–ketamine versus propofol–fentanyl for emergency department procedures

Hong Kong Journal of Emergency Medicine ◽

10.1177/1024907919893466 ◽

2020 ◽

pp. 102490791989346

Author(s):

Shahrad Tajoddini ◽

Mojdeh Motaghi

Keyword(s):

Recovery Time ◽

Statistical Tests ◽

Data Gathering ◽

Chi Square ◽

Double Blind ◽

Analgesic Effects ◽

Emergency Procedures ◽

Chi Square Test ◽

Group B ◽

Sedative Drugs

Background: To manage and reduce painful procedures in the emergency wards, procedural sedation as well as analgesia can be used. Propofol combinations are the most common short-acting intravenous sedative drugs in the field of emergency medicine. Objectives: This research aimed to compare the effectiveness, safety, and complications of intravenous infusion of ketofol with fentofol in painful emergency procedures. Methods: This study was a randomized, double-blind clinical trial. Sampling was simple and used random assignment; 196 participants were randomly assigned to two groups of 98 patients each. In each group, injection was done with fentanyl–propofol or ketamine–propofol. For data gathering, pre-procedure, and procedure, modified Aldrete’s scoring checklist was used. In order to determine the levels of sedation, we used the Ramsay Sedation Scale. Data analysis was performed via SPSS Version 20 using statistical tests such as mean ± standard division, t-test, chi-square test, and analysis of variance. Results: Among the participants in this study, shoulder procedure was performed more than other procedures (56.6%). The mean of recovery time was significantly different in the two groups (ketofol: 5.65 ± 0.35 vs fentofol: 9.33 ± 0.78); the recovery time in group B (fentofol) was longer than that in group A (ketofol) (p = 0.001). Drug complications were statistically significant in the two groups, and complications by ketofol were less than those by fentofol (p = 0.001). “Hypotension and bradycardia” were observed with fentofol and “tachycardia” was observed with ketofol. The performance of these two drugs was not the same when subject to various procedures. Conclusion: Results of this study revealed that ketofol provided better analgesia and sedation, faster recovery time, lesser complications and adverse events, and reduced bradycardia and hypotension.

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Comparison of the effects of Dexamethasone and Ondansetron on the Reduction of Postoperative Nausea and Vomiting following Cesarean Section under Spinal Anesthesia

Current Clinical Pharmacology ◽

10.2174/1574884715666200302122800 ◽

2020 ◽

Vol 15 ◽

Author(s):

Arash karimi ◽

Jahanbakhsh Nejadi ◽

Mahnaz Shamseh ◽

Nooshin Ronasi ◽

Mehdi Birjandi

Keyword(s):

Cesarean Section ◽

Spinal Anesthesia ◽

Postoperative Nausea ◽

Demographic Data ◽

Postoperative Nausea And Vomiting ◽

Nausea And Vomiting ◽

Elective Cesarean Section ◽

Double Blind ◽

Group A ◽

Group B

Background: Postoperative nausea and vomiting (PONV) is a common complication associated with the use of anesthesia. Several antiemetics are used to reduce the incidence and severity of PONV. The aim of this study is to investigate the role of dexamethasone and ondansetron to treat PONV in patients undergoing cesarean section (c-section) under spinal anesthesia. Methods: This double-blind clinical trial study was performed on patients who were referred to the operating room of Haji Karim Asali Hospital of Khorramabad for elective cesarean section in 2016-17. Upon meeting the inclusion criteria, patients were allotted into two groups (n=60). Group A received 8mg of dexamethasone and group B received 4mg of ondansetron after spinal anesthesia. The Visual Analog Scale (VAS) questionnaire and Depression-Anxiety-Stress Scale (DASS) questionnaire was used for the analysis. Patients with mild to moderate stress, anxiety, and depression were included in the study. Data were analyzed using SPSS 16 software. Results: There was no difference in the demographic data of the two groups. The mean severity of nausea in group A was significantly higher than in group B. The frequency of vomiting in group A was 20 times higher than group B, which was found to be statistically significant, p = 0.018. Concerning the type of delivery with the frequency of nausea, the results showed that the frequency of nausea in group A was 3.24 times higher than group B, however, this difference was not statistically significant, p = 0.106. Conclusion: Based on the results of this study, ondansetron had a significant effect on the alleviation of postoperative nausea and vomiting, as compared to dexamethasone in c-section surgical candidates.

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Perbandingan Efektivitas Anestesi Spinal dengan Bupivacain 12,5 Mg dan Bupivacain 5 Mg yang ditambah Fentanyl 50 Mcg pada Seksio Sesarea

Jurnal Anestesi Obstetri Indonesia ◽

10.47507/obstetri.v4i1.55 ◽

2021 ◽

Vol 4 (1) ◽

pp. 11-7

Author(s):

Fritzky Indradata ◽

Heri Dwi Purnomo ◽

Muh. Husni Thamrin ◽

Sugeng Budi Santoso ◽

Ardana Tri Arianto ◽

...

Keyword(s):

Side Effects ◽

Cesarean Section ◽

Spinal Anesthesia ◽

Randomized Control Trial ◽

Hyperbaric Bupivacaine ◽

Chi Square ◽

Double Blind ◽

Duration Of Action ◽

Significant Difference ◽

Randomized Control

Latar Belakang: Anestesi spinal mempunyai efek samping berupa hipotensi dan mual muntah. Tujuan: penelitian ini adalah membandingkan efek anestesi spinal bupivacain dosis normal 12,5 mg dan bupivacain dosis rendah 5 mg dengan fentanyl 50 mg pada seksio sesarea terhadap perubahan hemodinamik, ketinggian blok, onset, durasi dan efek samping. Subjek dan Metode: Penelitian double blind randomized control trial pada 36 pasien yang memenuhi kriteria. Pasien dibagi menjadi dua kelompok, yang masing-masing terdiri 18 pasien, kelompok 1 dilakukan anestesi spinal dengan bupivacain hiperbarik 5 mg ditambah adjuvan fentanyl 50 mcg, sedangkan kelompok 2 diberikan bupivacain hiperbarik 12,5 mg. Penilaian meliputi saat mula kerja blokade sensorik, mula kerja blokade motorik, durasi, tekanan darah, laju nadi, dan saturasi oksigen, lama kerja dan efek samping. Data hasil penelitian diuji secara statistik dengan uji chi-square. Hasil: Terdapat perbedaan signifikan pada onset dan durasi blokade sensorik dan motorik, bupivacain 12,5 mg lebih baik dibandingkan bupivacain 5 mg + fentanyl 50 mcg (p<0.05). Tidak ada perbedaan signifikan pada perubahan tanda vital dan efek samping (p>0.05). Simpulan: Bupivacain 12,5 mg menghasilkan onset lebih cepat dan durasi lebih lama dibandingkan bupivacain 5 mg + fentanil 50 mcg pada anestesi spinal untuk seksio sesarea Comparison of The Effectiveness Spinal Anesthesia with Bupivacaine 12,5 Mg and Bupivacaine 5 Mg added Fentanyl 50 Mcg in Caesarean Section Abstract Background: Spinal anesthesia has side effects such as hypotension and nausea and vomiting. Objective: The aim of this study was to compare the effects of spinal anesthesia with normal doses of 12,5 mg of bupivacaine and 5 mg of low-dose bupivacaine with fentanyl 50 mg in the cesarean section on hemodynamic changes, block height, onset, duration, and side effects. Subjects and Methods: Double-blind randomized control trial in 36 patients who met the criteria. Patients were divided into two groups, each consisting of 18 patients, group 1 underwent spinal anesthesia with 5 mg of hyperbaric bupivacaine plus 50 mcg of fentanyl adjuvant, while group 2 was given 12,5 mg of hyperbaric bupivacaine. Assessments include the initiation of sensory block action, onset of motor block action, duration, blood pressure, pulse rate, and oxygen saturation, duration of action, and side effects. The research data were statistically tested with the chi-square test. Results: There were significant differences in the onset and duration of sensory and motor blockade, bupivacaine 12,5 mg was better than bupivacaine 5 mg + fentanyl 50 mcg (p <0.05). There was no significant difference in changes in vital signs and side effects (p> 0.05). Conclusion: Bupivacaine 12,5 mg resulted in a faster onset and longer duration than bupivacaine 5 mg + fentanyl 50 mcg in spinal anesthesia for cesarean section.

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ULTRASOUND PREDICTABILITY OF LOWER UTERINE SEGMENT CESAREAN SECTION SCAR THICKNESS

10.36106/ijsr/3520656 ◽

2020 ◽

pp. 9-11

Author(s):

Madhu Kumari ◽

Kumari Bibha ◽

Abha Sinha ◽

Debarshi Jana

Keyword(s):

Cesarean Section ◽

Gestational Age ◽

Statistical Significance ◽

P Value ◽

Chi Square ◽

Medical College ◽

Chi Square Test ◽

Uterine Scar ◽

Age Range ◽

The Given

Objective: The objective of this study is to find out association between scar thickness, assessed sonographically, and intraoperative findings (IOF). Study Design: Descriptive study. Place and Duration of Study: Department of Obstetrics and Gynecology, Sri Krishna Medical College and Hospital, Muzaffarpur, Bihar from June 2019 to May 2020. Methodology: A total of 70 pregnant patients were included in this study. Transabdominal ultrasound was done for scarred uteri. Sonographic findings were co-related with introperative findings. All the given data were entered on SPSS version 23. Age was expressed as mean ± SD. Parity, gestational age, and interval between cesarean sections were expressed as frequencies with percentages. Statistical analysis was done by using Chi-square test for categorical data for association between sonographic scar thickness and intraoperative findings. The statistical significance was set at p-value <0.05. Results: The age range of the patients was 20- 36 years with a mean of 27.91 ±3.690 years. Gestational age at the time of cesarean section was between 27-40 weeks of gestation with a mean of 37 ±2.126 weeks. The interval from previous cesarean was 10 months at the minimum, and 6 years at the maximum with a mean of 2.29 ±1.0 months. Mean scar thickness was 2.5 mm. Association between scar thickness (<1-3 mm) and intaoperative findings of dehiscence and rupture showed a p-value of <0.001. Conclusion: Sonographic assessment of a uterine scar has a practical application to determine the thickness of previous scar, and assess its integrity.

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A double-blind randomized placebo-controlled study of low dose mirtazapine once daily in patients of major depressive disorders on escitalopram

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20191602 ◽

2019 ◽

Vol 8 (5) ◽

pp. 1067

Author(s):

Mallikarjuna Rao I. ◽

Usha Kiran Prayaga ◽

Dharma Rao Uppada ◽

Ramachandra Rao E. ◽

B. L. Kudagi

Keyword(s):

Depressive Disorders ◽

Low Dose ◽

Rating Scale ◽

Controlled Study ◽

P Value ◽

Chi Square ◽

Double Blind ◽

Increased Risk ◽

Significant Difference ◽

Chi Square Test

Background: The SSRIs being used as 1st line therapy in treatment of depression have delayed therapeutic effect which makes the patient vulnerable to an increased risk of suicide and decreased adherence to the treatment and will prematurely discontinue the therapy. The present study was conducted to evaluate if low dose mirtazapine-escitalopram combination therapy has any add on benefit over monotherapy with escitalopram.Methods: In a single-centered, comparative study involving patients with depression attending the out-patient after screening and exclusion, 60 eligible patients were randomly assigned to receive tablet mirtazapine 7.5 mg plus tablet escitalopram 10 mg intervention or tablet escitalopram 10 mg plus placebo intervention in a double-blind 6-week treatment phase. The primary outcome measure was the change in the 17-item Hamilton Depression Rating Scale (HDRS) and Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline. Participants were evaluated at baseline, 1st, 2nd,4th and 6th week. Results were analyzed using Chi-Square test for adverse effects and independent t-test analysis for efficacy parameter.Results: In the analysis of results at 6th week the numbers of patients achieved remission in mirtazapine group are more with a p-value of 0.018 which is significant and the numbers of responders in mirtazapine group are also more which is statistically significant on chi-square test. There is no significant difference was observed between the two groups with reference to occurrence of adverse effect.Conclusions: Adding low dose mirtazapine has an added benefit in terms of efficacy and getting remission early with more number of responders in the treatment of major depression.

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Self-perception of side effects by adolescents in a chlorhexidine-fluoride-based preventive oral health program

Journal of Applied Oral Science ◽

10.1590/s1678-77572006000400015 ◽

2006 ◽

Vol 14 (4) ◽

pp. 291-296 ◽

Cited By ~ 7

Author(s):

Ana Rita Duarte Guimaraes ◽

Marco Aurélio Peres ◽

Ricardo de Sousa Vieira ◽

Rodrigo Melin Ferreira ◽

Maria Letícia Ramos-Jorge ◽

...

Keyword(s):

Oral Health ◽

Side Effects ◽

Adverse Effects ◽

Health Program ◽

Double Blind Study ◽

Chi Square ◽

Double Blind ◽

Chi Square Test ◽

Plaque Control ◽

Descriptive Scale

OBJECTIVE: The objective of this study was to evaluate the incidence of adverse effects reported by adolescents following 14 days of use of a mouthrinse containing 0.05% NaF+0.12% chlorhexidine. METHODS: This double-blind study was developed as part of a randomized clinical trial. The adolescents enrolled to the study were randomly divided into two groups to use either: 0.05% NaF+0.12% chlorhexidine (G1, n=85) or 0.05% NaF (G2, n=85). Both groups used a 10mL solution of the mouthwash during 1 minute daily for 2 weeks under supervision. After that period, the subject's acceptance of taste was measured using a verbal descriptive scale (Labeled Magnitude Scale - LMS)11. Participants were also interviewed regarding the occurrence of possible adverse effects during treatment (temporary palate disorders, tooth staining or unpleasant taste). The proportional differences between the groups were tested using the chi-square test. RESULTS: Palate changes were reported by 26% of participants of each group; 17.7% of G1 and 32% of G2 reported an unpleasant taste (p = 0.062), while staining was reported by 55% of G1 and 68.9% of G2 (p = 0.117). Absenteeism rates were similar in both groups (G1= 2.58 ± 2.69; G2=2.81 ± 2.39), p=0.362. CONCLUSION: adherence was high in both groups and side effects reported by subjects were not perceived by them as being important. Since subjects' acceptance and compliance is fundamental to the success of an oral health program, chlorhexidine-fluoride could be a useful resource in a program of plaque control.

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The optimal dose period of indisetron tablets for preventing chemotherapy-induced nausea and vomiting (CINV) induced by mFOLFOX6: An exploratory trial HGCSG0703.

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.4_suppl.589 ◽

2011 ◽

Vol 29 (4_suppl) ◽

pp. 589-589

Author(s):

S. Yuki ◽

H. Nakatsumi ◽

M. Tateyama ◽

Y. Uehata ◽

M. Kudo ◽

...

Keyword(s):

Single Dose ◽

Rescue Therapy ◽

Optimal Dose ◽

Nausea And Vomiting ◽

Complete Protection ◽

Chi Square ◽

Dose Period ◽

Chi Square Test ◽

Group A ◽

Group B

589 Background: Indisetron is a 5-HT3 receptor antagonist which shows also 5-HT4 antagonistic activity, that had approved in 2004 by Japan's PMDA. There are no recommendations of prophylactic regimens for preventing nausea and vomiting induced by FOLFOX therapy. To explore the optimal dose period of indisetron tablets during mFOLFOX6, we designed the study to compare the antiemetic efficacy and safety of 3-day regimen of indisetron with a single dose regimen. Methods: Advanced colorectal cancer patients who were treated with mFOLFOX6 (+/- bevacizumab) as first-line chemotherapy were enrolled in this study. They were randomly assigned to Group A (3-day of indisetron) or Group B (a single dose of indisetron). Dexamethazone (8mg) was also administered intravenously in both groups before administering of oxaliplatin. The follow-up period was 5 days from the start of chemotherapy. The primary endpoint was complete protection from vomiting, and secondary endpoints were complete protection from nausea, no use of rescue therapy, and severe adverse events. Results: Of 45 patients enrolled in this trial, 42 (93.3%) were assessable. The proportions of patients with complete protection from vomiting were 85.7% in Group A, and 81.0% in Group B (p=1.000; Fisher's exact test). The proportions of patients with complete protection from nausea were 47.6% in each group (p=1.000; chi-square test). The no rescue therapy rates were 66.7% in Group A, and 57.1% in Group B (p=0.525; chi-square test). No severe adverse events were observed in both groups. Conclusions: We suggested that the efficacy of a single dose of indisetron might be equivalent of 3-day regimen for preventing from nausea and vomiting induced by mFOLFOX6. [Table: see text]

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