scholarly journals Evaluation of propranolol, flunarizine and divalproex sodium in prophylaxis of migraine

2017 ◽  
Vol 6 (10) ◽  
pp. 2463
Author(s):  
Majid F. Bhat ◽  
Harpreet S. Sidhu ◽  
Manoj Goyal
Keyword(s):  
Preventive Treatment ◽  
Tolerability Profile ◽  
Divalproex Sodium ◽  
Duration Of Treatment ◽  
Open Label ◽  
Number Of Patients ◽  
Significant Difference ◽  
History Of ◽  
Efficacy Parameters ◽  
To Receive

Background: Preventive treatment has an important role in the management of migraine. Propranolol and flunarizine have been used for more than two decades while, open-label, controlled studies suggest divalproex sodium may also be efficacious for migraine prevention. The objective of the study to compare efficacy and safety of propranolol, flunarizine and divalproex sodium in patients for migraine prophylaxis.Methods: Following approval from IEC a 12-week randomized, open, comparative study was carried out at the outpatient department of Medicine. Patients between 18 to 65 years, with history of 3 to 12 migraines a month (IHS) for six months were included. Patients were divided into three groups of 30 patients to receive - propranolol 20 to 160mg/day; flunarizine 5 to 10mg/day or divalproex sodium 250 to 750mg/day, for three months.Results: Total 90/116 patients completed the study. No significant differences were found between the groups with regards to mean age or other baseline migraine features. All the drugs significantly decreased the frequency, duration and severity of migraine (P<0.001). There is no statistically significant difference between propranolol, flunarizine and divalproex sodium for any of the efficacy parameters. All the three treatments were well-tolerated and safe.Conclusions: All the three study drugs were equally effective with an acceptable tolerability profile, Divalproex sodium group showed more side effects, none of which were serious. However, further studies with larger number of patients and longer duration of treatment are recommended.

scholarly journals 651. Comparative Analysis Between Bacterial And Fungal Malignant Otitis Externa

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S383-S384
Author(s):  
Fatma Hammami ◽  
Makram Koubaa ◽  
Amal Chakroun ◽  
Fatma Smaoui ◽  
Khaoula Rekik ◽  
...  
Keyword(s):  
Otitis Externa ◽  
Clinical Presentation ◽  
The Elderly ◽  
Causative Organism ◽  
Diabetic Patients ◽  
Duration Of Treatment ◽  
Evolutionary Features ◽  
Significant Difference ◽  
Malignant Otitis Externa ◽  
History Of

Abstract Background Malignant otitis externa is a fatal infection of the external ear and temporal bone. Pseudomonas aeruginosa is the most common causative organism, while fungi are a rare cause of malignant otitis externa. We aimed to compare the clinical, therapeutic and evolutionary features between bacterial and fungal malignant otitis externa. Methods We conducted a retrospective study including all patients hospitalized for malignant otitis externa in the infectious diseases department between 2000 and 2018. Results Overall, we encountered 82 cases of malignant otitis externa, among which there were 54 cases (65.9%) of bacterial malignant otitis externa (BMO) and 28 cases (34.1%) of fungal malignant otitis externa (FMO). The males were predominant among BMO cases (57.4% vs 50%; p=0.5). Patients with FMO were significantly older (70±9 years vs 61±10 years; p&lt; 0.001) and had medical history of diabetes mellitus more frequently (96.4% vs 77.8%; p=0.03). The use of topical corticosteroids was significantly more reported among FMO cases (28.6% vs 5.6%; p=0.006). Otalgia (96.4% vs 81.5%), otorrhea (75% vs 66.7%) and cephalalgia (46.4% vs 42.6%) were the revealing symptoms among FMO and BMO, respectively, with no significant difference. Tenderness to palpation of the mastoid bone (64.3% vs 38.9%; p=0.02) and stenosis of the external auditory canal (92.9% vs 72.2%; p=0.02) were significantly more frequent among FMO cases. Complications were significantly more frequent among FMO cases (42.9% vs 9.3%; p&lt; 0.001). Treatment duration was significantly longer among FMO cases (70[40-90] days vs 45[34-75] days; p=0.03). Conclusion Our study showed that FMO affected more frequently the elderly and diabetic patients, when compared with BMO. Regardless of the causative agent, the clinical presentation was similar. However, the outcome was poor among FMO cases with the occurrence of complications, requiring a longer duration of treatment. Disclosures All Authors: No reported disclosures

TOP-PRO study: A randomized double-blind controlled trial of topiramate versus propranolol for prevention of chronic migraine

Cephalalgia ◽  
2021 ◽  
pp. 033310242110474
Author(s):  
Debashish Chowdhury ◽  
Luv Bansal ◽  
Ashish Duggal ◽  
Debabrata Datta ◽  
Ankit Mundra ◽  
...  
Keyword(s):  
Adverse Events ◽  
Chronic Migraine ◽  
Virus Disease ◽  
Controlled Trial ◽  
Preventive Treatment ◽  
Point Estimate ◽  
Tolerability Profile ◽  
Double Blind ◽  
Significant Difference ◽  
The Mean

Objective The aim of the TOP-PRO-study, a double-blind randomized controlled trial, was to assess the efficacy (non-inferiority) and tolerability of propranolol compared to topiramate for the prevention of chronic migraine. Background Except for topiramate, oral preventive treatment for chronic migraine lacks credible evidence. Methods Chronic migraine patients aged above 18 years and less than 65 years of age, not on any preventive treatment were randomly allocated to receive topiramate (100 mg/day) or propranolol (160 mg/day). The primary efficacy outcome was the mean change in migraine days per 28 days at the end of 24 weeks from baseline. A mean difference of 1.5 days per four weeks was chosen as the cut-off delta value. Multiple secondary efficacy outcomes and treatment emergent adverse events were also assessed. Results As against the planned sample size of 244, only 175 patients could be enrolled before the spread of the corona virus disease-2019 pandemic and enforcement of lockdown in India. Of the 175 randomized patients, 95 (topiramate 46 and propranolol 49) completed the trial. The mean change in migraine days was −5.3 ± 1.2 vs −7.3 ± 1.1 days (p = 0.226) for topiramate and propranolol groups respectively. Propranolol was found to be non-inferior and not superior to topiramate (point estimate of −1.99 with a 95% confidence interval of −5.23 to 1.25 days). Multiple secondary outcomes also did not differ between the two groups. Intention to treat analysis of 175 patients and per-protocol analysis of 95 patients yielded concordant results. There was no significant difference in the incidence of adverse events between the two groups. Conclusion Propranolol (160mg/day) was non-inferior, non-superior to topiramate (100mg/day) for the preventive treatment of chronic migraine and had a comparable tolerability profile. Trial Registration: Clinical Trials Registry-India CTRI/2019/05/018997)

scholarly journals Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

2021 ◽  
Author(s):  
Peter W Horby ◽  
Guilherme Pessoa-Amorim ◽  
Natalie Staplin ◽  
Jonathan R Emberson ◽  
Enti Spata ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Usual Care ◽  
Rate Ratio ◽  
Invasive Mechanical Ventilation ◽  
Standard Of Care ◽  
Open Label ◽  
Absolute Increase ◽  
Significant Difference ◽  
Randomised Controlled ◽  
To Receive

Background: Aspirin has been proposed as a treatment for COVID-19 on the basis of its antithrombotic properties. Methods: In this randomised, controlled, open-label trial, several possible treatments were compared with usual care in patients hospitalised with COVID-19. Eligible and consenting adults were randomly allocated in a 1:1 ratio to either usual standard of care alone or usual standard of care plus 150mg aspirin once daily until discharge using web-based simple (unstratified) randomisation with allocation concealment. The primary outcome was 28-day mortality. The trial is registered with ISRCTN (50189673) and clinicaltrials.gov (NCT04381936). Findings: Between 01 November 2020 and 21 March 2021, 7351 patients were randomly allocated to receive aspirin and 7541 patients to receive usual care alone. Overall, 1222 (17%) patients allocated to aspirin and 1299 (17%) patients allocated to usual care died within 28 days (rate ratio 0.96; 95% confidence interval [CI] 0.89-1.04; p=0.35). Consistent results were seen in all pre-specified subgroups of patients. Patients allocated to aspirin had a slightly shorter duration of hospitalisation (median 8 days vs. 9 days) and a higher proportion were discharged from hospital alive within 28 days (75% vs. 74%; rate ratio 1.06; 95% CI 1.02-1.10; p=0.0062). Among those not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (21% vs. 22%; risk ratio 0.96; 95% CI 0.90-1.03; p=0.23). Aspirin use was associated with an absolute reduction in thrombotic events of 0.6% (SE 0.4%) and an absolute increase in clinically significant bleeding of 0.6% (SE 0.2%). Interpretation: In patients hospitalised with COVID-19, aspirin was not associated with reductions in 28-day mortality or in the risk of progressing to invasive mechanical ventilation or death but was associated with a small increase in the rate of being discharged alive.

scholarly journals 096 Assessment of the efficacy of erenumab during the open-label treatment (13–24 weeks) of subjects with episodic migraine who failed 2–4 prior preventive treatments: results of the LIBERTY study

2019 ◽  
Vol 90 (e7) ◽  
pp. A31.1-A31
Author(s):  
Lauren Giles ◽  
Uwe Reuter ◽  
Peter Goadsby ◽  
Michel Lanteri-Minet ◽  
Peggy Hours-Zesiger ◽  
...  
Keyword(s):  
Treatment Phase ◽  
Preventive Treatment ◽  
Episodic Migraine ◽  
Open Label ◽  
Double Blind ◽  
Open Label Extension ◽  
Specific Medication ◽  
Continuous Use ◽  
To Receive ◽  
Headache Impact

IntroductionTo assess efficacy of erenumab in the first three months of the open-label extension phase (OLEP; 13–24 weeks) of the LIBERTY study.MethodsIn the double-blind treatment phase (DBTP), 246 patients were randomized to placebo and erenumab 140 mg for 12 weeks, following which, patients completing that phase (N=240) were enrolled in OLEP, to receive monthly erenumab 140 mg. Outcomes measured monthly throughout to week 24 were achievement of at least 50%/75%/100% reduction in monthly migraine days (MMD), change from DBTP baseline in MMD, monthly acute migraine-specific medication days (MSMD), Headache Impact Test (HIT-6TM) total score, everyday activities (EA) and physical impairment (PI) as measured by the Migraine Physical Function Impact Diary (MPFID).ResultsOverall, 228/240(95.0%) patients completed the 24 week visit of the OLEP. In the overall population at Week 24, 39.2%, 15.9% and 7.0% patients achieved ≥50%/≥75%/100% reduction in MMD. The mean (standard deviation) change from DBTP baseline in MMD was −2.7(4.4) and −1.4(3.0) in MSMD; and −7.6(8.0), −2.5(9.2) and −4.0(9.0) in HIT-6TM, MPFID-PI and MPFID-EA scores respectively. Patients with continuous use of erenumab showed sustained efficacy in all outcomes assessed. Patients who switched from placebo to erenumab in the OLEP showed improvement from the first measurement at Week 16 on all outcomes assessed.ConclusionsEfficacy of erenumab was sustained throughout 24 weeks in a hard to treat patient population with multiple prior preventive treatment failures. Overall, efficacy data over 24 weeks (assessed over weeks 13–16,17–20 and 21–24) was generally in line with prior erenumab trials.

scholarly journals CLINICAL EVALUATION OF AYURVEDIC FORMULATION OF COLICARMIN PLUS SYRUP ON COLIC, GRIPING PAIN, INDIGESTION, NAUSEA, VOMITING, AND OTHER DIGESTIVE DISORDERS IN PAEDIATRICS AND GERIATRICS PATIENTS.

2016 ◽  
pp. 114
Author(s):  
Devendra Mishra ◽  
Girish H Patel ◽  
Rupali Gathani
Keyword(s):  
Side Effects ◽  
Geriatric Patients ◽  
Total Duration ◽  
Nausea And Vomiting ◽  
Duration Of Treatment ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Number Of Patients ◽  
Digestive Disorders

<p>ABSTRACT<br />Objective: An open label study to assess the effect of colicarmin plus syrup on colic and griping pain, indigestion, nausea and vomiting in children,<br />and geriatric patients.<br />Methods: (a) A study was conducted on 75 number of patients to evaluate the effect of colicarmin plus syrup on colic and griping pain, indigestion,<br />nausea and vomiting in children, and adults, (b) mostly these children were selected from different classes of families, (c) all the patients were checked<br />on the 1<br />st<br />, 2<br />nd<br />, and 3<br />rd<br /> week after starting the therapeutic dose.<br />Dosage schedule: (a) Children: 1 Teaspoonful thrice a day after meals, (b) adults: 2 Teaspoonful twice to thrice a day after meals.<br />Results: (a) Colic and griping pain: In the total duration of treatment, no of patients recovering were 23-on 1<br />st<br /> week, 4-on 2<br /> week,<br />overall result is 93.54%, (b) indigestion: In the total duration of treatment, no of patients recovering were 26-on 1<br />st<br />nd<br /> week, and 3-on 3<br /> week, 3-on 2<br /> week, and 1-on<br />3<br />rd<br /> week, the overall result is 93.75%, (c) nausea and vomiting: In the total duration of treatment, no of patients recovering were 8-on 1<br /> week, 2-on<br />2<br />nd<br /> week, and 1-on 3<br />rd<br /> week, the overall result is 91.33%.<br />Conclusion: Based on the study, we can conclude that colicarmin plus syrup is an Ayurvedic formulation with benefits such as digestive, carminative,<br />anthelmintic, antiflatulent, antispasmodic, and devoid of side effects.<br />Keywords: Digestive, Carminative, Anthelmintic, Antiflatulent and Antispasmodic.<br />nd</p><p>st</p><p>rd</p>

Factors Affecting the Development of Atrial Fibrillation and Atrial Flutter (AF) Following Autologous Hematopoietic Stem Cell Transplantation (auto-HSCT).

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 1754-1754
Author(s):  
Mary Lee H. Villanueva ◽  
Fausto R. Loberiza ◽  
James O. Armitage ◽  
Robert G. Bociek ◽  
Apar Kishor Ganti ◽  
...  
Keyword(s):  
Serum Creatinine ◽  
Multivariate Model ◽  
Disease Stage ◽  
Hematopoietic Stem ◽  
Post Transplant ◽  
Factors Associated ◽  
Mediastinal Irradiation ◽  
Number Of Patients ◽  
Significant Difference ◽  
History Of

Abstract Background: The use of auto-HSCT has expanded to include older patients. Age is a risk factor for the development of AF in the general population. As more elderly patients undergo auto-HSCT, the risk of developing AF post-transplant may also increase. The development of AF may increase morbidity, may prolong hospitalization, and may increase the cost of hospitalization. However, few data exist evaluating the factors that contribute to the development of AF following auto-HSCT. At our institution, we have observed a large number of patients with this complication. Therefore, we performed a retrospective case-control study to determine the incidence of AF following auto-HSCT and to determine risk factors associated with the development of AF. Patients and Methods: We performed a chart review on all patients at our institution who received an auto-HSCT from November 1999 to May 2004. Cases were identified by reviewing EKGs performed post-transplant. Controls consisted of patients with similar age, year of transplant, and underlying hematologic malignancy. The following variables were examined for their association with AF: age, sex, diagnosis, disease stage at transplant, conditioning regimen, year of transplant, previous medical history including cardiac history, pre-transplant cardiology work-up, and electrolyte abnormalities immediately following auto-HSCT. Patients who developed AF were compared to controls. Multivariate logistic regression was done to evaluate the factors associated with the development of AF. Results: During the study period, 44 patients developed AF at a median of four days (range days 1–9) following auto-HSCT; incidence of 8.5%. We identified 516 patients who did not develop AF who had auto-HSCT in the same time period. Of these, 179 patients with similar characteristics were used as controls. The following variables were associated with developing AF in the multivariate model: age at transplant; median age 63 yrs (50–72) for cases vs 57 (49–72) for controls (p&lt;0.001), abnormal renal function as determined by serum creatinine (p=0.008), history of previous arrhythmia (p&lt;0.001), and a history of mediastinal irradiation (p=0.003). Although not significant in the multivariate model, we observed that 45% of the patients who developed AF had increased left atrial size on a pre-transplant echocardiogram as opposed to none in the controls (p&lt;0.001). There was no difference in the length of hospital stay between the cases and controls (p=0.13). We did not detect a significant difference in the 100d survival between those who did and did not develop AF (90% vs 96%, p=0.25). However, patients who did not develop AF had a better overall survival (Log-rank p=0.04). Conclusions: Patients with older age, elevated serum creatinine level, history of previous arrhythmia, or history of previous mediastinal irradiation are more likely to develop AF following an auto-HSCT. Future studies should investigate whether interventions such as prophylactic beta-blockers can decrease the incidence of AF following auto-HSCT.

Dasatinib 50 mg or 70 mg BID compared to 100 mg or 140 mg QD in patients with CML in chronic phase (CP) who are resistant or intolerant to imatinib: One-year results of CA180034

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7004-7004 ◽  
Author(s):  
N. P. Shah ◽  
D. W. Kim ◽  
H. M. Kantarjian ◽  
P. Rousselot ◽  
P. E. Dorlhiac-Llacer ◽  
...  
Keyword(s):  
Kinase Inhibitor ◽  
Chronic Phase ◽  
Progression Free Survival ◽  
Response Rates ◽  
Primary Objective ◽  
Molecular Response ◽  
Duration Of Treatment ◽  
Open Label ◽  
Number Of Patients ◽  
One Year

7004 Background: Previous data with dasatinib (SPRYCEL®), a short-acting oral multitargeted kinase inhibitor of BCR-ABL and SRC family kinases, have shown the safety and efficacy of the 70 mg BID dose in CP-CML patients. Surprisingly, phase-I data (NEJM 2006;354:2531) demonstrated complete hematologic (CHR) and major cytogenetic responses (MCyR) among CP-CML patients at total daily doses (TDD) of 100 mg and 140 mg in both the BID and QD schedule, despite the achievement of only transient inhibition of BCR-ABL by dasatinib when administered once daily. Methods: Patients with CP-CML resistant or intolerant to imatinib were randomized to one of 4 dasatinib arms: 1) 100 mg QD; 2) 50 mg BID; 3) 140 mg QD; 4) 70 mg BID. In this randomized, prospective, open-label trial, the primary objective compared the CyR rate among the BID and QD arms. Secondary objectives included comparison of the CyR rate between TTDs of 100 and 140 mg and the safety among the 4 arms. Results: 662 patients were randomized from July 2005 to March 2006 and received treatment. Response rates, with a median duration of treatment of 8 months, are shown below. Duration of CyR and progression-free survival were similar across all 4 arms. There was significantly less grade (Gr) 3–4 neutropenia (P=0.035), thrombocytopenia (P=0.001), anemia (P=0.032), and pleural effusions (P=0.028) in the 100-mg QD arm compared to the other 3 arms combined. No differences were seen across the 4 arms in the rates of other adverse events. There were fewer interruptions and reductions and the least number of patients discontinuing treatment for drug-related toxicity in the 100-mg QD arm. Conclusions: Dasatinib 100 mg QD offers the most favorable benefit-risk ratio in CP-CML. This trial provides the first evidence that intermittent kinase inhibition can achieve deep clinical remissions and is associated with an improved safety profile. One-year follow-up on all subjects, molecular response rates, and BCR-ABL mutation data will be presented. [Table: see text] [Table: see text]

Standard Anesthetic Technique for Middle Ear Surgical Procedures: A Comparison of Desflurane and Sevoflurane

2005 ◽  
Vol 133 (2) ◽  
pp. 269-274 ◽  
Author(s):  
W. Scott Jellish ◽  
Kevin Owen ◽  
Steven Edelstein ◽  
Elaine Fluder ◽  
John P. Leonetti
Keyword(s):  
Middle Ear ◽  
Operating Conditions ◽  
Anesthetic Technique ◽  
Middle Ear Surgery ◽  
Pain Scores ◽  
Significant Difference ◽  
Discharge Readiness ◽  
History Of ◽  
Blood Pressures ◽  
To Receive

Objective: This study was designed to compare desflurane and sevoflurane anesthesia for middle ear microsurgery. Study Design: One hundred healthy adults undergoing middle ear surgery were assigned to receive either desflurane or sevoflurane as their anesthetic. Intraoperative hemodynamics and BIS numbers were recorded. Hemodynamics, pain, nausea/vomiting, discharge readiness, and other parameters were compared postoperatively and 24 hours later. Results: No intraoperative differences were noted except in BIS scores which trended lower with desflurane. PACU blood pressures were higher after desflurane but pain scores, nausea/vomiting, rescue anti-emetics, recovery scores, and discharge times were similar. A significant difference was noted in anesthetic costs (desflurane > sevoflurane), and in patients with the lowest BIS scores associated with more nausea/vomiting. Conclusions: Both anesthetics may be used for ototic surgery but propofol anesthesia should still be considered in patients with a history of emetic sequelae. Significance: Short-acting inhalational anesthetics produce excellent operating conditions and reduce costs for otologic surgery.

Comparative Pharmacodynamics of Intravenous Lidocaine in Patients with Acute and Chronic Ventricular Arrhythmias

1992 ◽  
Vol 26 (6) ◽  
pp. 763-767 ◽  
Author(s):  
Daniel E. Hilleman ◽  
Syed M. Mohiuddin ◽  
Aryan N. Mooss ◽  
Claire B. Hunter ◽  
Christopher J. Destache ◽  
...  
Keyword(s):  
Ventricular Arrhythmias ◽  
Plasma Concentrations ◽  
Acute Onset ◽  
Constant Infusion ◽  
Ventricular Premature Beat ◽  
Ventricular Ectopy ◽  
Intravenous Lidocaine ◽  
Open Label ◽  
Number Of Patients ◽  
Significant Difference

OBJECTIVE: To evaluate the pharmacodynamics of intravenous lidocaine in patients with acute-onset and chronic ventricular arrhythmias. DESIGN: Open-label, pharmacodynamic evaluation. SETTING: Private, university-affiliated, hospital coronary-care unit. PATIENTS: Twenty cardiac patients with acute-onset ventricular ectopy and 20 with chronic ventricular ectopy. INTERVENTIONS: Intravenous lidocaine was administered to all patients as a 1-mg/kg bolus, a 0.5-mg/kg bolus, and a 2.8-mg/min constant infusion for 48 hours. MAIN OUTCOME MEASURES: Changes in ventricular premature beat (VPB) frequency against total treatment period frequency and by an hour-to-hour assessment of changes in VPB frequency compared with total baseline frequencies. Response was defined as ≥80 percent total VPB reduction, ≥90 percent paired VPB reduction, and total abolition of nonsustained ventricular tachycardia events. RESULTS: A statistically significant difference in the pharmacodynamic effects of lidocaine were observed during the first eight hours of treatment in patients with acute-onset and chronic VPBs. The number of patients with acute-onset VPBs who responded to lidocaine in the first hour of treatment did not change significantly over the remaining hours of treatment. Response to lidocaine was less in patients with chronic VPBs than in patients with acute-onset VPBs. The response rate to lidocaine was significantly less during the first eight hours in patients with chronic VPBs than in patients with acute-onset VPBs. Following eight hours of treatment, the response rates between acute-onset and chronic VPB patients were not significantly different. Mean lidocaine plasma concentrations were not different between the groups. In addition, there were no significant differences in the incidence of adverse effects between the two groups. CONCLUSIONS: The onset of antiarrhythmic effect as measured by suppression of ventricular ectopy is delayed in patients with chronic VPBs compared with patients with acute-onset VPBs. Decisions about lidocaine response in patients with chronic VPBs cannot be made accurately in the first eight hours of therapy.

scholarly journals The spinal adjuvent - intrathecal nalbuphine as effective as intrathecal fentanyl

2020 ◽  
Vol 11 (3) ◽  
pp. 4492-4498
Author(s):  
Pratibha Deshmukh ◽  
Medha Sangawar ◽  
Nikita Dhumne ◽  
Vivek Chakole
Keyword(s):  
Dural Puncture ◽  
Local Anaesthetics ◽  
Hyperbaric Bupivacaine ◽  
Time Duration ◽  
Post Dural Puncture Headache ◽  
Intraoperative Hypotension ◽  
Number Of Patients ◽  
Significant Difference ◽  
To Receive

Opioids are favoured as adjuvants to local anaesthetics for spinal anaesthesia. The present study was aimed to compare the clinical efficiency of intrathecal nalbuphine with fentanyl as an adjuvant to 0.5% hyperbaric bupivacaine. 100 adult patients of either sex, ASA grade I and II, aged 18–60 years were randomized into two groups of 50 each to receive either fentanyl 25 μg (Group BF) or nalbuphine 500µg (Group BN) with 3 ml 0.5% hyperbaric bupivacaine, making drug volume to 3.5 ml in each group. Sensory and motor block characteristics, duration of analgesia, VAS score, haemodynamic and side effects were recorded. The sensorimotor characteristics were comparable and found no significant difference between the two groups, (P>0.05). The time duration for adequate analgesia in group BN was 366.40 ± 37.32min, and in the group, BF was 361.39 ± 43.96min, (P= 0.567). In both, the groups, quality of analgesia during the procedure was excellent in a maximum number of patients (96% each group). Sedation score, hemodynamic and respiratory rate changes were comparable between the two groups. In group BF, 4 (8%) patients complained nausea/ vomiting, pruritus was observed in 2 (4%), intraoperative hypotension in 3 (6%) and bradycardia in 2 (4%) and post-dural puncture headache in 2 patient (4%). In group BN, only bradycardia was observed in 3 (6%) patients. Nalbuphine and fentanyl were found to be equally efficient, but nalbuphine had a lower side effect profile, readily available as it does not come under the Narcotic act. However, we suggest Nalbuphine-bupivacaine combination as a better alternative than fentanyl-bupivacaine combination.

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