Evaluation of Oral Robenacoxib for the Treatment of Postoperative Pain and Inflammation in Cats: Results of a Randomized Clinical Trial

The efficacy and safety of robenacoxib were assessed for the control of postoperative pain and inflammation in cats. The study was a multicenter, prospective, randomized, blinded, and parallel group clinical trial. A total of 249 client-owned cats scheduled for forelimb onychectomy plus either ovariohysterectomy or castration surgeries were included. All cats received butorphanol prior to anesthesia and forelimb four-point regional nerve blocks with bupivacaine after induction of general anesthesia. Cats were randomized to receive daily oral tablet robenacoxib, at a mean (range) dosage of 1.84 (1.03–2.40) mg/kg , or placebo , once prior to surgery and for two days postoperatively. Significantly fewer robenacoxib cats received additional analgesia rescue therapy (16.5%) than placebo cats (46.3%). Pain elicited on palpation of the soft tissue incision site, behavior following social interaction, and posture assessed during the first 8 hours after extubation were significantly improved in cats receiving robenacoxib. Frequency of reported adverse clinical signs, hematology, serum chemistry and urinalysis variables, and body weight changes weresimilar between groups. In conclusion, robenacoxib was effective and well tolerated in the control of postoperative pain and inflammation in cats undergoing onychectomy with ovariohysterectomy or castration.

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Effects of curcumin-piperine co-supplementation on clinical signs, duration, severity, and inflammatory factors in patients with COVID-19: a structured summary of a study protocol for a randomised controlled trial

Trials ◽

10.1186/s13063-020-04924-9 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Mahsa Miryan ◽

Mohammad Bagherniya ◽

Amirhossein Sahebkar ◽

Davood Soleimani ◽

Mohammad Hossein Rouhani ◽

...

Keyword(s):

Clinical Trial ◽

Sample Size ◽

Inflammatory Mediators ◽

Disease Duration ◽

Clinical Symptoms ◽

Clinical Signs ◽

Inflammatory Factors ◽

Double Blind ◽

Full Protocol ◽

To Receive

Abstract Objectives This study aims to investigate the efficacy of curcumin-piperine co-supplementation on disease duration, severity and clinical symptoms, and inflammatory mediators in patients with coronavirus (COVID-19). Trial design This is a randomized, placebo-controlled, double-blind, parallel arm clinical trial. Participants All patients aged 20-75 years with the diagnosis of Covid-19 based on the PCR test. The exclusion criteria will include an age less than 20 and more than 75 years, current use of warfarin or other anticoagulant drugs, and the presence of sensitivity to herbal products such as turmeric and pepper. This study will be conducted in academic hospitals affiliated to Isfahan University of Medical Sciences, Isfahan, Iran. Intervention and comparator Fifty outpatients will be randomly allocated in a ratio of 1:1 to receive a capsule of curcumin-piperine containing 500 mg curcumin plus 5 mg piperine or matching placebo containing 505 mg maltodextrin twice a daily, after lunch and dinner, over a period of 2 weeks. Similarly, 50 inpatients who are admitted to hospital wards excluding intensive care unit (ICU) will be randomly assigned in a ratio of 1:1 to receive a capsule curcumin-piperine or matching placebo (provided by the Sami Labs company) twice a daily, after lunch and dinner, over a period of 2 weeks. Main outcomes The main outcomes of this study are the efficacy of curcumin-piperine on coronavirus disease’s clinical symptoms, duration, severity, and inflammatory mediators after 2 weeks of curcumin-piperine co-supplementation. Randomisation Randomization sequences will be generated with the use of a random-number table with a permuted block design (block size of 4) and stratification according to the gender variable (male vs. female). These sequences will be prepared by an independent statistician and will be kept in opaque, sealed, numbered envelopes which will be opened only at the time of enrollment. The allocation ratio in intervention and control groups is 1:1. Researchers and all patients will be unaware of the study-group assignment until the completion of data analyses. Blinding (masking) This study is a double-blind clinical trial (participant, researcher). The curcumin-piperine and placebo supplements are packaged in similar numbered drug containers, and the researcher and all patients will be unaware of the study assignment until the end of the study. Numbers to be randomised (sample size) The calculated total sample size is 100 patients, with 25 patients in each group. Trial Status The protocol is Version 2.0, May 24, 2020. Recruitment began May 4, 2020, and is anticipated to be completed by April 19, 2021. Trial registration This trial has been registered by the title of “Effect of curcumin-piperine co-supplementation on disease duration, severity and clinical signs, and inflammatory factors in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial study” in the Iranian Registry of Clinical Trials (IRCT) with code “IRCT20121216011763N46”, https://www.irct.ir/trial/47529. The registration date is May 4, 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

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Efficacy of Mesoglycan in Pain Control after Excisional Hemorrhoidectomy: A Pilot Comparative Prospective Multicenter Study

Gastroenterology Research and Practice ◽

10.1155/2018/6423895 ◽

2018 ◽

Vol 2018 ◽

pp. 1-8 ◽

Cited By ~ 2

Author(s):

Gaetano Gallo ◽

Massimiliano Mistrangelo ◽

Roberto Passera ◽

Valentina Testa ◽

Mauro Pozzo ◽

...

Keyword(s):

Postoperative Pain ◽

Multicenter Study ◽

Management Strategies ◽

Postoperative Bleeding ◽

Treated Group ◽

Control Group ◽

Oral Tablet ◽

Postoperative Thrombosis ◽

Pain Symptoms ◽

To Receive

Introduction. Various pain management strategies for patients undergoing open excisional hemorrhoidectomy have been proposed, yet postoperative pain remains a frequent complaint. Objective. To determine whether mesoglycan (30 mg two vials i.m. once/day for the first 5 days postoperative, followed by 50 mg 1 oral tablet twice/day for 30 days) would reduce the edema of the mucocutaneous bridges and thus improve postoperative pain symptoms. Patients and Methods. For this prospective observational multicenter study, 101 patients undergoing excisional diathermy hemorrhoidectomy for III-IV degree hemorrhoidal disease were enrolled at 5 colorectal referral centers. Patients were assigned to receive either mesoglycan (study group SG) or a recommended oral dose of ketorolac tromethamine of 10 mg every 4–6 hours, not exceeding 40 mg per day and not exceeding 5 postoperative days according to the indications for short-term management of moderate/severe acute postoperative pain, plus stool softeners (control group CG). Results. Postoperative thrombosis (SG 1/48 versus CG 5/45) (p<0.001) and pain after rectal examination (p<0.001) were significantly reduced at 7–10 days after surgery in the mesoglycan-treated group, permitting a faster return to work (p<0.001); however, in the same group, the incidence of postoperative bleeding, considered relevant when needing a readmission or an unexpected outpatient visit, was higher, possibly owing to the drug’s antithrombotic properties. Conclusions. The administration of mesoglycan after an open diathermy excisional hemorrhoidectomy can reduce postoperative thrombosis and pain at 7–10 days after surgery, permitting a faster return to normal activities.

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Correlation between body weight changes and postoperative pain in rats treated with meloxicam or buprenorphine

Lab Animal ◽

10.1038/laban0309-87 ◽

2009 ◽

Vol 38 (3) ◽

pp. 87-93 ◽

Cited By ~ 17

Author(s):

Matthew P. Brennan ◽

Albert J. Sinusas ◽

Tamas L. Horvath ◽

J.G. Collins ◽

Martha J. Harding

Keyword(s):

Body Weight ◽

Postoperative Pain ◽

Weight Changes ◽

Body Weight Changes

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Efficacy of Anesthetic Agents to Delay Pain Onset After Periodontal Surgery

Anesthesia Progress ◽

10.2344/0003-3006-58.2.57 ◽

2011 ◽

Vol 58 (2) ◽

pp. 57-60 ◽

Cited By ~ 1

Author(s):

Joao Paulo Steffens ◽

Márcia Thaís Pochapski ◽

Fábio André Santos ◽

Gibson Luiz Pilatti

Keyword(s):

Postoperative Pain ◽

Pain Intensity ◽

Pain Perception ◽

Clinical Signs ◽

Periodontal Surgery ◽

Anesthetic Agents ◽

Parallel Group ◽

Group 2 ◽

Double Blinded ◽

Group 1

Abstract The aim of this study was to evaluate the influence of 2 anesthetic agents on patients' postoperative pain perception after periodontal surgery. For this parallel-group, double-blinded, randomized clinical trial, 36 open flap debridement surgeries were performed on patients who presented with periodontal disease with clinical signs of inflammation after nonsurgical treatment on at least 1 quadrant. Patients were allocated to 1 of the following groups: group 1, 2% lidocaine with 1 ∶ 100,000 epinephrine; group 2, 2% mepivacaine with 1 ∶ 100,000 norepinephrine. Pain intensity was assessed using the visual analog scale during the first 8 hours after surgery. All patients received 750-mg acetaminophen tablets, which they were instructed to take as a rescue medication if necessary. The results demonstrated that postoperative pain intensity was statistically lower in group 2 than in group 1 at the 1-, 2-, and 3-hour periods after surgery, although the pain intensity for all groups could be considered mild. In conclusion, patients in both groups reported similar mild pain after periodontal surgery.

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Glide Path Enlargement of Curved Molar Canals Using HyFlex EDM Glide Path File versus PathFile: A Comparative Study of Preparation Times and Postoperative Pain

10.21203/rs.3.rs-28602/v1 ◽

2020 ◽

Author(s):

Yi Han ◽

Xiao-Mei Hou

Keyword(s):

Clinical Trial ◽

Postoperative Pain ◽

Comparative Study ◽

Randomized Clinical Trial ◽

Pain Severity ◽

Preparation Time ◽

Cavity Preparation ◽

Glide Path ◽

To Receive

Abstract Background This randomized clinical trial aimed to compare the preparation times and severity of postoperative pain between the HyFlex EDM Glide Path File and PathFile. Methods Eighty patients who were treated by the same specialist were enrolled. After access cavity preparation, the patients were randomly assigned to receive glide path enlargement with either HyFlex EDM GPF or PathFile. ProTaper Next X1 and X2 files were used to prepare the canals. The time of preparation was assessed and the severity of postoperative pain over the next 7 days was recorded. Results Preparation time and postoperative pain severity were significantly lower in the HyFlex EDM GPF group compared to that in the PathFile group ( P < 0.05 for both). Conclusion Postoperative pain and glide path preparation time could be reduced by using the HyFlex EDM GPF system.

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A Clinical Trial of Adding Morphine to Levobupivacaine in TAP Block for Open Appendectomy

QJM ◽

10.1093/qjmed/hcab086.038 ◽

2021 ◽

Vol 114 (Supplement_1) ◽

Author(s):

Sherif Farouk Ibrahim ◽

Kareem Youssef Kamal Hakim ◽

Wael Sayed Ahmed Abdelghaffar Elgharabawy ◽

Hebatullah Ramadan Muhammad

Keyword(s):

Clinical Trial ◽

Postoperative Pain ◽

Abdominal Wall ◽

Postoperative Analgesia ◽

Open Appendectomy ◽

Transversus Abdominis ◽

Controlled Clinical Trial ◽

Tap Block ◽

Nerve Blocks ◽

Double Blind

Abstract Background Postoperative pain management is becoming an integral part of anaesthesia care. Various techniques of pain relief have been designed among which the most commonly practiced are peripheral nerve blocks. We have designed the study to assess analgesic efficacy, duration of postoperative analgesia, hemodynamic stability, and total need of analgesics and opioids after adding morphine to levobupivacaine in TAP block for open appendectomy. A substantial component of the pain experienced by patients after major abdominal surgery is derived from the abdominal wall incision. The abdominal wall consists of three muscle layers, the external oblique, the internal oblique and the transversus abdominis, and their associated fascial sheaths. This muscular wall is innervated by nerve afferents that course through the transversus abdominis neuro-fascial plane. Different adjuvants have been studied to improve the quality and increase the duration of local anaesthetics during various nerve block techniques. Aim of the work The aim of this study is to assess the analgesic effect of peripherally administered morphine with levobupivacaine for ipsilateral TAP block in patients undergoing appendectomy under general anaesthesia. Patient and Methods Type of Study prospective, randomized and double blind controlled clinical trial. Study Setting Ain Shams University Hospitals. Study Period 6 months. Sampling Method randomized double blind clinical trial. suction evacuation for molar pregnancy, all cases were included in the study were agreed on a consent for inclusion in the current study after explanation for the details of the study. Conclusion TAP block was effective in reducing postoperative pain scores, lowering total 24-h postoperative analgesic consumption. Morphine as an adjunct to levobupivacaine in ipsilateral ultrasound guided transversus abdominis plane block as more effective postoperative analgesia with reduced analgesic requirement in patients undergoing appendectomy.

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Extended Perineural Analgesia After Hip and Knee Replacement When Buprenorphine-Clonidine-Dexamethasone Is Added to Bupivacaine: Preliminary Report from a Randomized Clinical Trial

Pain Medicine ◽

10.1093/pm/pnaa229 ◽

2020 ◽

Vol 21 (11) ◽

pp. 2893-2902

Author(s):

Brian A Williams ◽

James W Ibinson ◽

Marsha E Ritter ◽

Catalin S Ezaru ◽

Hulimangala R Rakesh ◽

...

Keyword(s):

Postoperative Pain ◽

Knee Replacement ◽

Mean Difference ◽

Nerve Blocks ◽

Double Blind ◽

Knee Replacement Surgery ◽

Joint Replacement Surgery ◽

Replacement Surgery ◽

Time Parameters ◽

To Receive

Abstract Objective We tested the hypothesis that buprenorphine-clonidine-dexamethasone (BCD) extends perineural analgesia compared with plain bupivacaine (BPV) nerve blocks used for hip and knee replacement surgery. Design Prospective, parallel-arms, randomized, double-blind trial. Setting A single veterans’ hospital. Subjects Seventy-eight veterans scheduled for total hip or knee replacement with plans for spinal as the primary anesthetic. Methods Participants underwent nerve/plexus blocks at L2–L4 and L4–S3 in advance of hip or knee joint replacement surgery. Patients were randomized to receive BPV-BCD or plain BPV in a 4:1 allocation ratio. Patients answered four block duration questions (listed below). Time differences between treatments were analyzed using the t test. Results Significant (P < 0.001) prolongation of the time parameters was reported by patients after the BPV-BCD blocks (N = 62) vs plain BPV (N = 16). The time until start of postoperative pain was 26 vs 11 hours (mean difference = 15 hours, 95% CI = 8 to 21). The time until no pain relief from the blocks was 32 vs 15 hours (mean difference = 17 hours, 95% CI = 10 to 24). The time until the numbness wore off was 37 vs 21 hours (mean difference = 16 hours, 95% CI = 8 to 23). The time until the worst postoperative pain was 39 vs 20 hours (mean difference = 19 hours, 95% CI = 11 to 27). Conclusions BPV-BCD provided 26–39 hours of perineural analgesia in the L2–L4 and L4–S3 nerve distributions after hip/knee replacement surgery, compared with 11–21 hours for plain BPV.

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A bioequivalence study of proposed bevacizumab biosimilar, MYL-1402O (A) vs EU-Avastin (B) and US-Avastin (C).

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e14034 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e14034-e14034 ◽

Cited By ~ 1

Author(s):

Mark A. Socinski ◽

Matthew Hummel ◽

Tjerk Bosje ◽

Andrew Shaw ◽

Mark Shiyao Liu ◽

...

Keyword(s):

Clinical Trial ◽

Healthy Adult ◽

Bioequivalence Study ◽

Primary Objective ◽

Double Blind ◽

Safety Issues ◽

Parallel Group ◽

Healthy Adult Male ◽

To Receive ◽

Clinical Trial Information

e14034 Background: MYL-1402O is a proposed bevacizumab biosimilar. The similarity of MYL-1402O to Avastin has been demonstrated in physicochemical analyses, and nonclinical studies. Methods: This single-center, randomized, double blind, three-arm, parallel-group, study was conducted in healthy adult male volunteers. The primary objective of this study was to establish PK similarity of A to B and C, and B to C. Subjects were randomized to receive either A, B or C 1 mg/kg over 90 minutes as an intravenous infusion. Dose was selected based on the lower dose in the linear range of PK and acceptable safety in healthy volunteers. Bioequivalence was to be concluded if the 90% CIs of the ratios (A/B, A/C and B/C) of LS means of the natural log transformed AUC0-inf were within 80% to 125%. AUC0-t, Cmax, tmax, kel and t½ were assessed as secondary PK parameters. Results: A total of 111 subjects (37/treatment) were enrolled and 110 [37 (A), 36 (B), 37(C)] were included in the analysis. Bioequivalence was demonstrated between A and B, A and C and between B and C. LS mean ratios were close to 1, and 90% CIs were within 0.80 to 1.25 for all of the comparisons. The secondary PK parameters were also comparable with the 90% CIs for ratios of AUC0-t and Cmax within 80%-125%. A total of 313 TEAEs were reported, 116 by 33 (89%) subjects who received A, 99 by 29 (78%) subjects who received B and 98 by 28 (76%) subjects who received C. Most TEAEs were consistent with the clinical data of bevacizumab (Avastin). No serious or unexpected TEAEs were reported. TEAEs were grade 1 or grade 2 in severity. The anti-drug antibodies are being evaluated (pending results). Conclusions: These results confirm bioequivalence of Myl-1402O vs. EU-Avastin and US-Avastin. All treatments were well tolerated and no significant safety issues emerged. Clinical trial information: NCT02469987 Clinical trial information: NCT02469987.

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Use of maropitant for the control of pruritus in non-flea, non-food-induced feline hypersensitivity dermatitis: an open-label, uncontrolled pilot study

Journal of Feline Medicine and Surgery ◽

10.1177/1098612x18811372 ◽

2018 ◽

Vol 21 (10) ◽

pp. 967-972 ◽

Cited By ~ 3

Author(s):

Elisa Maina ◽

Jacques Fontaine

Keyword(s):

Therapeutic Option ◽

Treatment Options ◽

Clinical Signs ◽

Controlled Study ◽

Weight Changes ◽

Open Label ◽

Body Weight Changes ◽

Score System ◽

Short Time ◽

Pruritic Skin

Objectives Non-flea, non-food-induced hypersensitivity dermatitis (NFNFIHD) is a common inflammatory and pruritic skin disease in cats. When avoidance and conventional systemic immunosuppressive treatments fail to control the clinical signs, there are limited treatment options. The aim of this study was to evaluate the efficacy and tolerability of maropitant in feline NFNFIHD. Methods In an open-label, uncontrolled study, cats with proven non-seasonal NFNFIHD were treated with maropitant 2 mg/kg PO q24h for 4 weeks. Clinical lesions were evaluated with the Scoring Feline Allergic Dermatitis (SCORFAD) system and pruritus was evaluated with a 10 cm visual analogue scale (VAS) before and at the end of the study. Owners assessed global efficacy and tolerability with a 4-point scale at the end of the study. Adverse events and body weight changes were recorded. Results Twelve cats were treated with a mean initial maropitant dose of 2.22 mg/kg PO q24h. The treatment decreased both SCORFAD and pruritus VAS (pVAS) scores in all cats except one, in which only pruritus was reduced. The efficacy and the tolerability of the treatment were judged as excellent or good by 83.3% of owners. Treatment did not cause any side effects other than, in a few cases, short-time, self-limiting sialorrhoea. Conclusions and relevance Maropitant seems to be an effective, well-tolerated therapeutic option to control pruritus in cats. Caution is needed in interpreting the results as the pVAS score system has not yet been validated in cats and the trial was uncontrolled. A further, controlled study is required to confirm our findings.

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Glide Path Enlargement of Curved Molar Canals Using HyFlex EDM Glide Path File versus PathFile: A Comparative Study of Preparation Time and Postoperative Pain

10.21203/rs.3.rs-28602/v2 ◽

2020 ◽

Author(s):

Yi Han ◽

Xiao-Mei Hou

Keyword(s):

Clinical Trial ◽

Postoperative Pain ◽

Preparation Time ◽

Cavity Preparation ◽

Electric Discharge Machine ◽

Pain Scores ◽

Glide Path ◽

Discharge Machine ◽

To Receive ◽

Over Time

Abstract Background: This randomized clinical trial aimed to compare the preparation time and severity of postoperative pain between the HyFlex Electric Discharge Machine (EDM) Glide Path File (GPF) and PathFile.Methods: Eighty patients who were treated by the same specialist were enrolled. After access cavity preparation, the patients were randomly assigned to receive glide path enlargement with either HyFlex EDM GPF or PathFile. ProTaper Next X1 and X2 files were used to prepare the canals. The time of preparation was assessed and the severity of postoperative pain over the next 7 days was recorded. The preparation time and the postoperative pain scores were compared using one-way analysis of variance (ANOVA) (P ≤ 0.05).Results: Glide path enlargement was significantly shorter with HyFlex EDM GPF (27.828 ± 2.345 s) than with PathFile (48.942 ± 2.864 s) (P < 0.001). The highest postoperative pain score was recorded on the first day and the pain decreased over time in both groups. GPF group patients reported significantly less postoperative pain than PathFile group patients overall (P < 0.05).Conclusion: Postoperative pain and glide path preparation time could be reduced by using the HyFlex EDM GPF system.Trial registration: PKUSSNCT, PKUSSNCT-17B12, Registered 24 October 2017

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