Comparison of Ondansetron with Gabapentin for prevention of intrathecal morphine induced pruritus

Background: Ondansetron has been used successfully for prophylaxis and treatment of intrathecal morphine induced pruritus. Gabapentin has anxiolytic, antiemetic, antipruritic effects and has also been shown to potentiate the analgesic effect of intrathecally or epidurally administered opioids. Materials and method: We compared the effectiveness of oral gabapentin with intravenous ondansetron to prevent incidence of intrathecal morphine induced pruritus. In a prospective, double-blind study, sixty patients aged 18-65 years with ASA physical status I and II undergoing surgery under subarachnoid block were randomized to receive placebo tablets (ondansetron group) or gabapentin 1200 mg (gabapentin group) 2 hours before surgery. Patients receiving placebo tablets received 8 mg of intravenous ondansetron and those receiving gabapentin received 4 ml of intravenous normal saline just prior to subarachnoid block with 3 ml of 0.5% hyperbaric bupivacaine plus 0.2 mg morphine. The incidence, onset, severity, location of pruritus and incidence of side effects were studied for next 24 hours. Results: The overall incidence of pruritus was 48.3%. The incidence, severity, location of pruritus was comparable between the two groups. There was significant difference between the onset of pruritus between groups (p=0.009). The incidence and grade of nausea vomiting, requirement of intraoperative sedation was comparable between groups. The incidence of urinary retention was significantly high in gabapentin group (p=0.020). Respiratory depression was observed in one patient. Conclusion: A single dose of 1200 mg oral gabapentin 2 hours before, is as effective as prophylactic intravenous ondansetron 8 mg for prevention of intrathecal morphine induced pruritus.

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Duloxetine augmentation in resistant obsessive compulsive disorder: Surveying a new medication for challenges in treatment of OCD

European Psychiatry ◽

10.1016/j.eurpsy.2017.01.361 ◽

2017 ◽

Vol 41 (S1) ◽

pp. S415-S415

Author(s):

A. Mowla

Keyword(s):

Obsessive Compulsive Disorder ◽

Primary Outcome Measure ◽

Controlled Clinical Trial ◽

Double Blind Study ◽

Obsessive Compulsive ◽

Double Blind ◽

Compulsive Disorder ◽

Significant Difference ◽

Competing Interest ◽

To Receive

IntroductionUp to 50% of patients with OCD have failed to respond in SSRI trials, so looking for pharmacological alternatives in treatment of obsessive compulsive disorder (OCD) seems necessary.ObjectivesSurveying duloxetine augmentation in treatment of resistant OCD.AimsStudy the effects of serotonin-norepinephrine enhancers for treatment of OCD.MethodsThis augmentation trial was designed as an 8-week randomized controlled, double blind study. Forty-six patients suffering from OCD who had failed to respond to at least 12 weeks of treatment with a selective serotonin reuptake inhibitor (fluoxetine, citalopram or fluvoxamine) were randomly allocated to receive duloxetine or sertraline plus their current anti OCD treatment. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) was the primary outcome measure.ResultsForty-six patients (24 of 30 in duloxetine group and 22 of 27 in sertraline group) completed the trial. Both groups showed improvement over the 8-week study period (mean Y-BOCS total score at week 8 as compared with baseline: P < 0.001 and P < 0.001) without significant difference (P = 0.861). Those receiving duloxetine plus their initial medications experienced a mean decrease of 33.0% in Y-BOCS score and the patients with sertraline added to their initial medication experienced a mean decrease of 34.5% in Y-BOCS.ConclusionsOur double blind controlled clinical trial showed duloxetine to be as effective as sertraline in reducing obsessive and compulsive symptoms in resistant OCD patients. However, it needs to be noted that our study is preliminary and larger double blind placebo controlled studies are necessary to confirm the results.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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Clinical benefits of preemptive oral clonidine versus oral tramadol for abdominal hysterectomy conducted under subarachnoid block with 0.5% hyperbaric bupivacaine: a comparative evaluation

International Journal of Research in Medical Sciences ◽

10.18203/2320-6012.ijrms20173001 ◽

2017 ◽

Vol 5 (7) ◽

pp. 3129

Author(s):

Kumkum Gupta ◽

Swati Sharma ◽

Prashant K. Gupta ◽

Guljeet Kaur ◽

Vasundra Tyagi ◽

...

Keyword(s):

Muscle Relaxation ◽

Abdominal Hysterectomy ◽

Hyperbaric Bupivacaine ◽

Subarachnoid Block ◽

Oral Clonidine ◽

Significant Difference ◽

Clinical Benefits ◽

Intraoperative Period ◽

American Society ◽

To Receive

Background: Neuraxial techniques possess many benefits for elective abdominal hysterectomy due to profound surgical anesthesia and muscle relaxation. The present study was aimed to compare the clinical benefits of pre-emptive oral clonidine with oral tramadol for abdominal hysterectomy conducted under subarachnoid block with 0.5% hyperbaric bupivacaine.Methods: Sixty adult female patients of American Society of Anaesthesiologists (ASA) physical status I and II, aged 42 to 65 years, were randomized into two groups of 30 patients each to receive either oral clonidine, 100 µg (Group C) or oral tramadol 50 mg tramadol (Group T), 90 min before initiation of subarachnoid block with 3.5 mL of 0.5% hyperbaric bupivacaine. Intraoperative hemodynamic changes, duration of analgesia and incidence of shivering were recorded as primary end points. Drug related effects of pruritus, sedation, nausea, vomiting, and respiratory depression were recorded as secondary outcomes.Results: The onset of sensory and motor block was comparable between the groups but the time to two dermatome regression were prolonged in patients of Group C with statistical significant difference (p=0.05). Duration of analgesia was also enhanced in patients of Group C (268.27±12.18 min versus 223.15±14.31 min in Group T) with statistically highly significant difference (p=0.000). The incidence of shivering was lower in the patients of clonidine group. The heart rate was lower in patients of clonidine throughout intraoperative period and no incidence of bradycardia, hypotension or sedation occurred in any patient.Conclusions: Both drugs showed clinical benefits as pre-emptive oral medication for abdominal hysterectomy conducted under subarachnoid block but oral clonidine (100 µg) proved to be more beneficial.

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Pyridoxine is not effective for the prevention of hand foot syndrome (HFS) associated with capecitabine therapy: Results of a randomized double-blind placebo-controlled study

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.9007 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 9007-9007 ◽

Cited By ~ 4

Author(s):

S. Lee ◽

Y. Chun ◽

M. Kim ◽

H. Chang ◽

...

Keyword(s):

Placebo Group ◽

Chemotherapy Regimen ◽

Controlled Study ◽

Double Blind Study ◽

Double Blind ◽

Significant Difference ◽

Hand Foot Syndrome ◽

Version 2.0 ◽

The Mean ◽

To Receive

9007 Introduction: Although pyridoxine has been used empirically for the prevention of HFS associated with capecitabine, its efficacy has not been proven yet. We performed a prospective randomized double-blind study to determine whether pyridoxine can prevent the development of HFS when given concurrently with capecitabine. Method: Chemotherapy-naive patients (pts) with gastrointestinal tract cancers who were going to have capecitabine-containing chemotherapy were randomized to receive either oral pyridoxine (200 mg/day) or placebo daily during chemotherapy after stratified by chemotherapy regimen: 1) capecitabine alone, 2) capecitabine and cisplatin, or 3) docetaxel, capecitabine, and cisplatin. The patients were observed until grade 2 or 3 HFS (by NCI CTC version 2.0) developed or capecitabine containing chemotherapy ended. When grade 2 or 3 HFS developed in pts in placebo group, the pts were randomized again to receive either pyridoxine or placebo for next cycle of chemotherapy in order to determine whether pyridoxine could improve the HFS. Result: From Jun 2004 to Oct 2005, total 389 pts were entered onto the study. But, 29 pts (15 in placebo group and 14 in pyridoxine group) were excluded from the study because of ineligibility or pts’ refusal. Pts’ characteristics were well balanced between the 2 groups. Grade 2 or 3 HFS developed in 55 of 180 (30.6%) pts in placebo group and in 57 of 180 (31.7%) pts in pyridoxine group. (p=0.788) The median cycles of chemotherapy to grade 2 or 3 HFS was 3 in both groups. The mean cumulative dose of capecitabine until occurrence of grade 2 or 3 HFS was not different statistically between the two groups. (221,157.5 mg/m2 vs. 259,808.5 mg/m2, p=0.788). Total 44 of 55 pts in placebo group who had grade 2 or 3 HFS were randomized to receive either placebo or pyridoxine at next cycle. There was no significant difference between the two groups in the proportion of pts with improvement of HFS (43% vs 48%, p=0.94). Conclusion: These results indicated that pyridoxine is not effective for the prevention of HFS associated with capecitabine therapy. No significant financial relationships to disclose.

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USE OF DEXMEDETOMIDINE AS AN ADJUVANT TO 0.5% HYPERBARIC BUPIVACAINE IN SUBARACHNOID BLOCK

10.36106/ijsr/5100889 ◽

2019 ◽

pp. 1-3

Author(s):

Dhananjay Yadav

Keyword(s):

Comparative Study ◽

Spinal Anaesthesia ◽

Low Dose ◽

Intrathecal Morphine ◽

Controlled Study ◽

Double Blind Study ◽

Hyperbaric Bupivacaine ◽

Double Blind ◽

Lower Limb Surgery ◽

Wonder Drug

[1] Kanazi GE, Aouad Mt, KJabbour-Khoury SI et al: Effect of low dose dexmedetomidine or clonidine on the characteristics of spinal bupivacaine block. Act a Anaesthesiol Scand 2006;50:222-7 [2] Hala EEA, Mohamed SA, Hend Y. Dose related prolongation of hyperbaric bupivacaine spinal anaesthesia by dexmedetomidine. Ain Shams J Anaesthesiology 2011;4:83-95 [3] Kim JE, Kim NY, Lee HS, Kil HK. Effects of intrathecal dexmedetomidine on low dose bupivacaine spinal anaesthesia in elderly patients undergoing transurethral prostectomy. Bio Pharm Bul 2013;36;959-965. [4] Mahendru V, Tewari A, Katyal S et al. A Comparison of intrathecal dexmedetomidine, clonidine, & fentanyl as adjuvants to hyperbaric bupivacaine for lower limb surgery: A double blind controlled study. J Anaesthesiol Clin Phrmacol 2013;29:496-502 [5] Soumya samal et al: Intrathecal buterphenol or intrathecal dexmedetomidine for post operative analgesia a comparative study: healt agenda, vol 2. Issue 1. Jan 2014 [6] Dexmedetomidine in anaesthesia practice: a wonder drug? IJAaug 2014 by S K Harsoor [7] Sudheesh K, Raghvendra Rao R S, Kavya M, Aarthi J, Rani D D, Nethra S S. Comprative study of 2 doses of intrathecal dexmedetomidine as adjunct with low dose hyperbaric bupivacaine in ambulatory perianal surgeries. A prospective randomized controlled study. Indian J Anaesth 2015;59:648-52 [8] El-Attar A, Aleen MA, Beltagy R, Ahmed W. A comparative study of intrathecal dexmedetomidine and fentanyl as additives to bupivacaine. Res Opin Anesth Intensive care 2015;1:43-9 [9] Kurhekar P, Kumar SM, Sampath D. Comparative evaluation of intrathecal morphine and intrathecal dexmedetomidine in patients undergoing gynecological surgeries under spinal anaesthesia. A prospective randomized double blind study. Indian J anaestg 2016;60:382-7

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Ultrasound Guided Infraclavicular Block for Pain Control After Upper Extremity Surgery

Hospital Practices and Research ◽

10.15171/hpr.2018.24 ◽

2018 ◽

Vol 3 (4) ◽

pp. 108-112

Author(s):

Derya Yalçın ◽

Dilek Erdoğan Arı ◽

Ceren Köksal ◽

Cansu Akın ◽

Sinan Karaca ◽

...

Keyword(s):

Patient Satisfaction ◽

Recovery Room ◽

Motor Block ◽

Double Blind Study ◽

Ultrasound Guided ◽

Nerve Blocks ◽

Double Blind ◽

Significant Difference ◽

Infraclavicular Block ◽

Group 2

Background: Opioids added to local anesthetics for peripheral nerve blocks may intensify analgesia and prolong analgesic and sensorial block duration. These agents may also cause potentiation and prolongation of motor block. Objective: This study compared the postoperative effects of 30 mL of 0.25% bupivacaine +50 mcg fentanyl and 30 mL of 0.25% bupivacaine + 100 mcg fentanyl solutions for the ultrasound-guided infraclavicular block in patients undergoing elbow and forearm surgery. Methods: In this randomized double-blind study, thirty-six patients with risk of ASA class I-III were randomly allocated into 2 randomized groups. Ultrasound-guided infraclavicular blocks with 30 mL of 0.25% bupivacaine + 50 mcg fentanyl for group 1 and 30 mL of 0.25% bupivacaine + 100 mcg fentanyl for group 2 were performed before patients emerged from general anesthesia. After surgery, pain levels at rest and during movement were evaluated using the 10-cm visual analog scale (VAS) at recovery room admission, at the 15th and 30th minutes in the recovery room, and at the 2nd, 6th, 12th and 24th hours postoperatively. Both morphine and rescue analgesic requirements were recorded. Sensorial and motor block durations, patient satisfaction, and complications related to the infraclavicular block were recorded. Results: In both groups, no significant difference in VAS pain scores, total morphine and total rescue analgesic requirements, duration of sensorial and motor block, or patient satisfaction were observed. None of the patients experienced any complications. Conclusion: The mixtures of 0.25% bupivacaine + 50 mcg fentanyl and 0.25% bupivacaine + 100 mcg fentanyl showed similar postoperative effects.

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A Randomized, Placebo-controlled, Double-blind Study on the Effects of SZL on Patients With Mild to Moderate Depressive Disorder With Comparison to Fluoxetine

10.21203/rs.3.rs-70759/v1 ◽

2020 ◽

Author(s):

yuan hu ◽

yichen wang ◽

chao chen ◽

wenshan yang ◽

weiyu zhu ◽

...

Keyword(s):

Depressive Disorder ◽

Depression Scale ◽

Double Blind Study ◽

Double Blind ◽

Moderate Depression ◽

Parallel Group ◽

Clinical Presentations ◽

Significant Difference ◽

To Receive ◽

Target Effects

Abstract Objective: Kaixinsan (KXS) decoction, as an ancient’s herbal formula, has been demonstrated to be active in various animal models resembling human depression with multi-target effects. This very first study evaluated the efficacy and tolerability of Shen Zhi Ling (SZL) tables (KXS preparation), compared with fluoxetine (FLX, positive comparator), in patients with mild to moderate depressive disorder.Methods: In this randomized double-blind parallel-group study, 156 patients with mild to moderate depression without taken any antidepressants in the past 6 months or 4 straight weeks were randomized to receive either 3.2g/d SZL plus 20mg/d FLX placebo (SZL group) or 20mg/d FLX plus 3.2g/d SZL placebo (FLX group), for 8 weeks. Their clinical presentations and some metabolic indexes were assessed during the 8 weeks visiting period.Results: Patients in SZL group showed a statistically significant improvement after 8 weeks of treatment in HAMD-17 score (18.79±2.09 to 4.43±4.71, p<0.001) and self-rating depression scale (SDS) score (58.49±8.89 to 39.84±12.09, p<0.001), but not in N-back total respond time (1145.55±608.26 to 1128.47±387.49, p>0.05). In addition, no significant difference at 8 weeks of treatment was found between SZL and FLX groups in SDS score (39.84±12.09 vs. 36.63±12.44) and N-back respond time (1128.47±387.49 vs. 1089.43±352.08) as well as reduction of HAMD-17 score (14.79±4.88 vs. 15.24±4.29) (p>0.05 for all). However, the serum APOB, APOC3 and ALB levels and HDL-C/LDL-C ratio decreased significantly in patients after SZL treatment, while only APOB/APOA1 ratio decreased significantly in FLX group. Other metabolic indexes did not alter significantly after treated with SZL or FLX.Conclusion: The efficacy and safety profile of SZL are comparable to that of fluoxetine in patients with mild to moderate depression. The beneficial effect of SZL is probably associated with improvement of lipid metabolic balance.

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A Comparison of Median Effective Doses of Intrathecal Levobupivacaine and Ropivacaine for Labor Analgesia

Anesthesiology ◽

10.1097/00000542-200503000-00026 ◽

2005 ◽

Vol 102 (3) ◽

pp. 651-656 ◽

Cited By ~ 30

Author(s):

Alex T. Sia ◽

Raymond W. Goy ◽

Yvonne Lim ◽

Cecilia E. Ocampo

Keyword(s):

Confidence Interval ◽

Probit Analysis ◽

Labor Analgesia ◽

Double Blind Study ◽

Double Blind ◽

Significant Difference ◽

Effective Doses ◽

To Receive ◽

Higher Doses ◽

Effective Analgesia

Background The study was designed to determine and compare the median effective doses (MEDs) of intrathecal ropivacaine with levobupivacaine for labor analgesia. Methods In this double-blind study, 100 parturients in early labor were randomized to receive either intrathecal ropivacaine or levobupivacaine. For each drug, the patients were assigned to receive one of the five doses studied, namely 1, 1.5, 2, 2.5, or 3 mg. Effective analgesia was defined as a pain score (0-100 visual analog scale) of less than 10 within 15 min of injection, lasting for 45 min or more after the induction of analgesia. MEDs were derived from probit analysis. The duration of analgesia rendered by the two drugs at 2.5 and 3 mg was also compared. Results The MED for levobupivacaine was 1.07 mg (95% confidence interval, 0.88-1.25 mg), and the MED for ropivacaine was 1.40 mg (95% confidence interval, 1.20-1.61 mg). Levobupivacaine was found to be 1.31 (95% confidence interval, 1.04-2.01) times more potent than ropivacaine. At doses of 2.5 mg or greater, there was no significant difference in duration of analgesia between levobupivacaine (median, 63.5 min; range, 46-123 min) and ropivacaine (median, 59.0 min; range, 47-93 min; P = 0.18). We detected no difference in the incidence of hypotension, nausea and vomiting, motor block, or abnormal fetal heart tracing between the two drugs. Conclusions The MED of intrathecal ropivacaine for labor analgesia was significantly greater than levobupivacaine experimentally, but this significance was reduced when the comparison was based on molar potency. There was no difference in the duration of analgesia or adverse effects between the two drugs at higher doses (2.5 mg or greater).

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The Influence of Adrenaline on Postoperative Analgesia after Subarachnoid Morphine

Anaesthesia and Intensive Care ◽

10.1177/0310057x9302100119 ◽

1993 ◽

Vol 21 (1) ◽

pp. 79-84 ◽

Cited By ~ 10

Author(s):

M. J. Paech

Keyword(s):

Side Effects ◽

Postoperative Analgesia ◽

Saline Group ◽

Control Group ◽

Double Blind Study ◽

Gynaecological Surgery ◽

Normal Saline Group ◽

Double Blind ◽

Significant Difference ◽

To Receive

A randomised, double-blind study was conducted to investigate the postoperative effects of subarachnoid morphine, with or without adrenaline, after major gynaecological surgery. Seventy-five women having spinal anaesthesia combined with either sedation or general anaesthesia were randomised to receive subarachnoid morphine 0.25 mg with (group MA) or without (group M) adrenaline 200 ūg; or normal saline (group C). Groups M (n=22) and MA (n=25) differed significantly from control (n=23) with respect to the quality and duration of postoperative analgesia (P<0.0002) and to a higher incidence of pruritus (P<0.02). Groups were similar with respect to the incidence of other postoperative side-effects and respiratory data, although the latter showed a trend to less hypoxaemia in the control group. There was no significant difference in any outcome between groups MA and M. It was concluded that, under the study conditions in a post-gynaecological surgery population, the addition of adrenaline to subarachnoid morphine was of no benefit.

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Intramuscular Ketorolac for Postoperative Analgesia following Laparoscopic Sterilisation

Anaesthesia and Intensive Care ◽

10.1177/0310057x9402200104 ◽

1994 ◽

Vol 22 (1) ◽

pp. 22-24 ◽

Cited By ~ 13

Author(s):

M. H. Shapiro ◽

B. L. Duffy

Keyword(s):

Side Effects ◽

Intramuscular Injection ◽

Double Blind Study ◽

Day Case ◽

Double Blind ◽

Apparent Lack ◽

Pain Scores ◽

Significant Difference ◽

To Receive ◽

Intramuscular Ketorolac

The analgesic effect of intramuscular ketorolac was assessed by double blind study in forty women presenting for day-case laparoscopic sterilisation. The patients were randomly allocated to receive either ketorolac 30 mg or saline by intramuscular injection immediately following induction of general anaesthesia. There was no statistically significant difference between the groups in pain scores, opioid requirements or incidence of nausea and vomiting in the postoperative period. In view of the potential side-effects of ketorolac, and the apparent lack of efficacy when used prophylactically, the routine use of the drug in this group of patients cannot be recommended.

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Evaluation of the efficacy of 150 micrograms of intrathecal morphine with bupivacaine compared to 250 micrograms for postoperative analgesia following abdominal hysterectomy: a double blinded randomized control study

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20190257 ◽

2019 ◽

Vol 6 (1) ◽

pp. 17

Author(s):

G. S. Sai Ram Prudhvi ◽

N. S. S. Naga Shyam ◽

Anand Acharya

Keyword(s):

Postoperative Analgesia ◽

Intrathecal Morphine ◽

Abdominal Hysterectomy ◽

Double Blind Study ◽

Hyperbaric Bupivacaine ◽

Double Blind ◽

Rescue Analgesia ◽

Group A ◽

Group B ◽

Preservative Free

Background: The synergistic action of local anesthetics and morphine is well known, morphine probably more superior for postoperative analgesia, when compared to other opioids. Preservative-free morphine is now available in India making intrathecal administration possible. The present randomized double blind study was designed to evaluate the effect of adding preservative free morphine to hyperbaric bupivacaine given intrathecally for abdominal hysterectomy.Methods: Following approval by the institutional review board and institutional research grant committee, eighty patients presenting for elective abdominal hysterectomy were included in this randomized, double blind study. All drugs used for spinal anesthesia were autoclaved as per the departmental protocol. 3.5 ml of hyperbaric bupivacaine 0.5% [heavy] was given in both groups along with preservative free morphine according to study group.Results: 27.5% (11/40) patients in group A, 17.5% (7/40) patients in group B received one dose of rescue analgesia (ketorolac 10 mg),during the 24 hours for pain relief while 29 patients is group A (72.5%) and 82.5% (33/40) patients in group B received 2 doses of rescue analgesia. 10% patients in Group A (4/40) and 10% patients in Group B (4/40) had a sedation score of 1 (drowsy and arousable).Conclusions: The mean duration of analgesia in patients who received 250 μgms of intrathecal morphine was 18.725±1.38 hours while in patients who received 150 μgms it is 16.075±1.23 hours. We conclude that 250 µgms of preservative-free intrathecal morphine provides longer duration of analgesia when compared to 150 µgms morphine, with hardly any additional adverse effects.

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