Diclofenac Sodium Injection Research Articles

Acupuncture for response and complete pain relief time of acute renal colic: Secondary analysis of a randomized controlled trial

BackgroundThe integration of acupuncture with intramuscular injection of diclofenac sodium can expedite the onset of analgesia in treating acute renal colic caused by urolithiasis. However, it remains unclear whether acupuncture can accelerate pain relief constantly until complete remission. This study aimed to explore the extent to which acupuncture can expedite the onset time of response or complete pain relief in treating acute renal colic, and the predictive value of patient characteristics for treatment efficacy. MethodsThis secondary analysis utilized data from a prior randomized controlled trial. Eighty patients with acute renal colic were randomly assigned 1:1 to the acupuncture group or the sham acupuncture group. After intramuscular injection of diclofenac sodium, acupuncture or sham acupuncture was delivered to patients. The outcomes included time to response (at least a 50 % reduction in pain) and complete pain relief. Between-group comparison under the 2 events was estimated by Kaplan-Meier methodology. Subgroup analysis was performed utilizing the Cox proportional hazards model. ResultsThe median response time and complete pain relief time in the acupuncture group were lower than those in the sham acupuncture group (5 vs 30 min, Log Rank P < 0.001; 20 min vs not observed, Log Rank P < 0.001, respectively). Hazard Ratios (HRs) for response across all subgroups favored the acupuncture group. All HRs for complete pain relief favored acupuncture, expect large stone and moderate pain at baseline. No interaction was found in either event. ConclusionAcupuncture can accelerate the response time and complete pain relief time for patients with acute renal colic, with the efficacy universally. Trial registrationThis study has been registered at Chinese Clinical Trial Registry: ChiCTR1900025202.

Effect of submucosal cryotherapy compared with steroids and NSAIDs injections on Substance P and Interleukin 6 pulpal release in experimentally induced pulpal inflammation in rabbits.

To compare the effect of submucosal cryotherapy using cold saline to dexamethasone sodium phosphate and diclofenac sodium injections on substance P and interleukin 6 release in experimentally induced pulpal inflammation in rabbits' molar teeth. Fifteen rabbits were randomly classified into 3 groups according to the submucosal injection given: cold saline, dexamethasone sodium phosphate, and diclofenac sodium. A split-mouth design was adopted, the right mandibular molars were experimental, and the left molars served as the control without injections. Intentional pulp exposures were created and left for 6 hours to induce pulpitis. Pulpal tissue was extracted and examined for SP and IL-6 levels using ELISA. Within each group, the level of cytokines released was measured for both control and experimental groups for intragroup comparison to determine the effect of injection. The percentage reduction of each mediator was calculated compared with the control side for intergroup comparison then the correlation between SP and IL-6 levels was analyzed using Spearman's rank order correlation coefficient. Statistical analysis was performed, and the significance level was set at p<0.05. Submucosal cryotherapy, dexamethasone sodium phosphate, and diclofenac sodium significantly reduced SP and IL-6 pulpal release. Submucosal cryotherapy significantly reduced SP more than and IL-6 more than dexamethasone sodium phosphate and diclofenac sodium. Pulpal reduction of SP and IL-6 showed a strong positive significant correlation. Submucosal cryotherapy reduces the pulpal release of SP and IL-6 and could be tested as an alternative to premedication to potentiate the effect of anesthesia and control postoperative endodontic pain.

Formulation Development and In Vitro Evaluation of Diclofenac Sodium Injection for Pain Management

Formulation Development and In Vitro Evaluation of Diclofenac Sodium Injection for Pain Management

Comparison of Pain Levels With Postoperative Intramuscular Administration of Single-Dose Ketoprofen Versus Diclofenac Sodium in Patients Undergoing Lower Third Molar Surgery.

Background Third molar surgeries are commonly performed in oral and maxillofacial surgery practice. Pain associated with this procedure is usually a frequent reason for patient apprehension and discomfort. Oral analgesics, though effective, do not provide sufficient pain relief in the immediate postoperative period. Aim To assess the postoperative effect on pain levels of single-dose administration of ketoprofen and diclofenac sodium as an injection in patients undergoing third molar removal surgeries. Methods This study was conducted among 30 patients divided into two groups (n=15). Patients in Group K received injection ketoprofen 100 mg and Group D included patients receiving injection diclofenac sodium 75 mg, both intramuscularly postoperatively. The intensity of pain was assessed at 30 minutes, two, six, and eight hours post-surgical removal of the impacted tooth using the visual analogue scale (VAS).The statistical data was analyzed using SPSS for Windows version 23.0 (IBM Corp., Armonk, NY, USA).The comparative statistical test adopted to compare pain scores between the two groupswas the Independent samples t-test. A p-value of <0.05 was considered to be statistically significant. Results Our study results revealed that Group K patient's VAS scores after two hours, six hours, and eight hours were 3.9± 2.7,4.5 ± 3.23,2.93 ± 2.27 respectively. In Group Dpatient's VAS scores aftertwo hours, six hours, and eight hours were 4.83± 2.82, 5.03± 2.9, 3.73 ± 2.91 respectively.Patients who were administered ketoprofen had lower pain levels when compared to patients who were given diclofenac but the difference was not statistically significant at any time point (p=0.172after eight hours). Our results depicted that the pain levels uniformly reached their maximal levels six hours after the procedure and thereafter steadily declined in both groups. Conclusion It can be concluded from the study that both the drugs ketoprofen and diclofenac sodium analyzed in this study can be used interchangeably for the reduction of pain following lower third molar surgery.

Comparison of post-tonsillectomy analgesic drugs (Paracetamol,Diclofenac sodium, and Tramadol)

To compare the effectiveness of using paracetamol, diclofenac sodium, and tramadol in controlling post tonsillectomy pain in immediate post-operative period. Sixty patients from 10 to 30 years old undergoing tonsillectomy by classical cold steei method and homeostasis done by ligation r,vith or without electrocauterization. We divided them into three groups according to the type of analgesic drug received in the immediate post operative period: Group A (20 patients) received paracetamol injection 15mg/kg/dose. Group B. (20 patients) received diclofenac sodium injection l.25mglkg lday. Group C (20 patients) received tramadol injectionlmg/kg/dose. Post-operative pain assessed clinically and according to visual analogue scales during rest and deglutition. 8 patients (40%) of group A have good response VAS less than 30 mm with mild discomfort, 15 patients (75%) of group B have good response and in group C 17 patients (85%) have VAS less than 30 mm with mild discomfort. There was significant difference between group B and C in comparison with group A (p:0.039), but there was no significant difference between group'B and group C (p &gt;0.05). Tramadol and diclofenac sodium are most effective in controlling post tonsillectomy pain even in those patients who have tonsillectomy with e lectrocauterization.

Acute limb ischemia due to diclofenac sodium iatrogenic intra-arterial injection: a case report

We report the case of accidental intra-arterial injection of diclofenac sodium in the brachial artery leading to acute limb ischemia. Iatrogenic intra-arterial injection is rarely reported in the literature; however, it is toxic and can lead to limb amputation. Only two cases of intra-arterial injection of diclofenac have been reported in the literature. The proposed pathophysiological mechanism is vasospasm, intravascular thrombosis, and chemical endoarteritis. The most common anatomical location in accidental intra-arterial injection is the antecubital fossa, where branches of the ulnar and brachial arteries are more superficial. The injection of medication must be as careful as possible, since the intra-arterial injection can affect the functional prognosis of the organ.

IN VITRO EVALUATION OF SOME BRANDS OF DICLOFENAC SODIUM INJECTION MARKETED IN GREATER NOIDA, UTTAR PRADESH, INDIA USING UV-VIS SPECTROPHOTOMETRIC METHOD

Quality is of principal subject to human beings in all perspective of life. When it comes to the quality of the pharmaceuticals which are consumed by humans, it is of most extreme significant as they are utilized for the prosperity of the humanity. In this study our objective was to evaluate the experimental in vitro study of the commercially obtainable Diclofenac Sodium injection brands which are available in Greater Noida. Ten different ampoules of 75mg/3ml diclofenac sodium injection products randomly collected from retail pharmacies and Govt. Hospital of targeted area in Greater Noida, Uttar Pradesh, India, twenty ampoules 75 mg/3ml have the same batch number of each brand were collected for the analysis. All the analytical methods were done in the quality control laboratories of JBJM Parenteral Pvt Ltd, Greater Noida, Uttar Pradesh, India. The study was carried out by performing various tests which is affiliated with the quality such asgeneral appearance of Diclofenac Sodium injection ampoule, Particulate matter, Average fill volume, pH and content assay through pH Meter (Spectra lab), UV-Vis Spectrophotometer (UV-1900i SHIMADZU). The assay was evaluated by UV-Vis Spectrophotometer at the wavelength of 276nm. The results show that diclofenac sodium injection following IP specification, it can be concluded that all of the 10 brands of the drug passed through UV-Vis spectroscopy method also in pH meter. The Spectroscopy method was successfully applied to evaluate of Diclofenac Sodium injection. KEYWORDS: In vitro evaluation, Diclofenac sodium injection, UV-Vis Spectroscopy, pH, Analytical method, Pharmaceutical analysis, SHIMADZU, Greater Noida, Spectroscopy, Quality evaluation

A Combined approach of surgery and negative pressure wound therapy in post intramuscular injection necrotizing fasciitis: A case report

Necrotizing fasciitis is one of the most severe soft tissue infections, having substantial fatality rates even in facilities with the highest standards. Typically, it first affects the muscular fascia before spreading to the muscles and subcutaneous tissues. Thus, the therapy for this illness depends on early detection. In this report, we present the case of an 18-year-old male who developed severe necrotizing fasciitis in the right gluteal area following an intramuscular injection of diclofenac sodium. The patient received significant surgical debridement, negative pressure wound therapy (NPWT), and antibiotics as part of their care. A split-thickness skin graft was used for reconstruction. Our results were outstanding as the wound totally healed. Overall, our findings portrayed the importance of taking serious action against soft tissue infections.

Nicolau’s syndrome following intramuscular administration of Diclofenac sodium

Nicolau’s syndrome, also known as embolia cutis medicamentosa or livedo-like dermatitis, is an uncommon rare cutaneous adverse reaction occurring at the site of intramuscular, intra-articular, or rarely subcutaneous injection of particular drugs, leading to necrosis of skin and underlying tissues. We, hereby, report two fatal cases of this syndrome after taking intramuscular injection of diclofenac sodium.

The histological effect of the injection of nonsteroidal anti-inflammatory drugs on sciatic nerve of rats

The ongoing work aims to compare the effect of extraneural and intraneural injection of therapeutic doses of meloxicam and diclofenac sodium on the sciatic nerve of rats. Six groups of adult albino rats were used with five animals per group. Control group (A), group (B), and group (C) received a single extraneural injection of normal saline (NS) 0.25 ml/kg/rat, meloxicam (M) 0.11 mg/kg/0.25ml/rat and diclofenac sodium (V) 1.1 mg/kg/0.25ml/rat respectively. In contrast, control group (D), group (E), and group (F) received a single intraneural injection of the same doses of normal saline, meloxicam, and diclofenac sodium, respectively. Histological evaluation reveals an increased thickening of epineurium, dilatation, congestion of epineurial blood vessels, intrafascicular edema, axonal degeneration, myelin degeneration, and vacuolization in group (C) which was higher than those in the group (B). These changes were also greater in group (F) compared to groups (D) and (E). The histopathological changes of the sciatic nerve were greatest in the case of intraneural injection of saline, meloxicam, and diclofenac sodium, which means that the damaging effect of intraneural injection of the drug was greater than the extraneural injection of the same drug. It is concluded that extraneural and intraneural injections of therapeutic doses of meloxicam cause less damage to the sciatic nerve compared to diclofenac sodium. Thus it is considered to be more secure than diclofenac sodium after intramuscular injection. Sciatic nerve injury can occur following intramuscular injection into the gluteal region, particularly if the needle hits the nerve.

Comparison of cold spray and shotblocker to reduce intramuscular injection pain: A randomized controlled trial.

It is important to identify effective, easy-to-use and cost-effective non-pharmacological methods in the management of pain caused by medical interventions. The purpose of this study is to compare the effects of cold spray and ShotBlocker on pain in adults in reducing pain caused by intramuscular injection in the adult emergency department. This is a randomized controlled trial with two experimental groups, two placebo groups and a control group. The study was conducted on 195 adults who received diclofenac sodium injections. In the study, the injection procedure was performed by following the same injection protocol in all five groups. In the injection process, cold spray or ShotBlocker was used in the intervention groups based on the group, and cold spray with distilled water or the smooth surface of the ShotBlocker was used in the placebo groups. Following the injection, the pain caused by the injection was evaluated using the Visual Analog Scale. The study was completed with the remaining 195 patients. In the study, the average pain scores due to injection of the individuals in the cold spray group were lower than those of the control group (p<0.05). There was no statistically significant difference between the pain score averages due to injection of the individuals in the ShotBlocker group and cold spray, control, ShotBlocker placebo and cold spray placebo groups. The routine use of a fast-acting, cost-effective and easy-to-use method, cold spray, to reduce pain in the intramuscular injection will be beneficial in increasing patient satisfaction and quality of care.

Effectiveness of Intramuscular Diclofenac Sodium Injection versus Diclofenac Suppositories in Post- Operative pain management in Inguinal Hernia

Background: This study was conducted to compare the route of administration of diclofenac intramuscular and suppository to see which one of these has more effectiveness. Aim: To compare intramuscular diclofenac sodium Injection with diclofenac suppositories in post operative pain management in patients with Inguinal Hernia. Study design: Randomized controlled trial and non probability consecutive sampling Methods: In this study 150 male cases accompanying age range of 18 to 60 age bearing unintended inguinal split were contained. They were detached into two equal groups and were trained accompanying subcutaneous injection of diclofenac sodium and those camp accompanying diclofenac suppositories. Post functioning pain was evaluated at 6, 12 and 24 hours on optic parallel scale (VAS). Results: In this study there were about up to 150 patients, 75 in each bunch and all were male. The average age in gather A and B was 43.50±5.72 vs 44.16±5.31 a long time individually. There were 47(62.67%) proficient in bunch A and 50(66.67%) in gather B. There were 58 cases each in both bunches having history of smoking. Require for protect absence of pain in bunch A was seen in 28 (37.33%) and in gather B in 19(25.33%) cases. Mean torment score on VAS at 6 hours was 2.39±0.84 vs 2.20±0.90 with p=0.64, at 12 hours it was 2.33±0.89 vs 2.11±0.94 with p= 0.94 and at 24 hours it was 2.03±0.71 vs 1.85±0.89 with p= 0.001. Conclusion: Post operative pain is one of the major concerns and Diclofenac suppositories have shown significantly better results at 24 hours as compared to intramuscular injections; though no statistical difference was observed at 6 and 12 hours. And this difference is also significant in terms of all the study variables at 24 hours in suppository group. Keywords: Inguinal Hernia, Diclofenac Sodium, Intramuscular, Suppository.

Clinical Evaluation of Analgesic Efficacy and Safety of IV Nalbuphine versus IV Butorphanol in Patients Undergoing Tympanoplasty: A Randomised Clinical Study

Introduction: Middle Ear Surgeries (MESs) are generally performed using local anaesthesia under sedation. Butorphanol and nalbuphine both are well-known synthetic opioid with agonist-antagonist characteristics. However, no reports present a direct comparison of the analgesic efficacy of these two drugs. Aim: To evaluate analgesic efficacy of intravenous butorphanol versus intravenous nalbuphine during Monitored Anaesthesia Care (MAC) in patients undergoing tympanoplasty. Materials and Methods: This randomised clinical trial was conducted at the Department of Anaesthesiology, School of Medicine, D.Y. Patil Deemed to be University, Mumbai, Maharashtra India, from March 2018 to March 2021. Total 112 adult patients, undergoing tympanoplasty, were randomly allocated into two groups. Group N received 0.2 mg/kg nalbuphine intravenous (i.v.) and group B received i.v. 0.02 mg/ kg butorphanol. The patients were then evaluated for analgesic efficacy, sedation, blood pressure, Mean Arterial Pressure (MAP), Heart Rate (HR), Respiratory Rate (RR), blood oxygen levels (SpO2 ), Visual Analogue Scale (VAS) Score, need for intraoperative rescue sedation/analgesia, duration of action and side-effects. Results: A significant difference was observed in the patients’ responses to needle prick, where only 8 (13.3%) subjects gave a vocal response in group N versus 22 (36.6%) in group B. A significant difference in the mean time of onset of pain amongst both the group was recorded (3.16±1.38 hrs in group N and 2.63±1.19 hrs in group B). A significant difference was also recorded in the mean VAS at 15th (p-value=0.012) and 30th min (p-value= 0.017). Only 7 patients (11.6%) from group N, and 12 patients (20%) from group B required rescue agent (0.5 mcg/kg/ hour dexmedetomidine injection and 75 mg diclofenac sodium injection intravenous). Conclusion: Both 0.2 mg/kg nalbuphine and 0.2 mg/kg butorphanolprovide satisfactory results in terms of analgesic efficacy, sedation, hemodynamic and respiratory parameters, albeit, nalbuphine can be coined to be superior in terms of response to pin prick and duration of action.

Evaluation of 0.25% bupivacaine vs. 0.375% ropivacaine for postoperative analgesia using ultrasound guided transversus abdominis plane block for caesarean section: A comparative study

Background: Pain after Caesarean section is described as moderate to severe by most patients. Ultrasound guided transversus abdominis plane (TAP) block is now increasingly being used for postoperative analgesia in lower abdominal surgeries. Hence this study was undertaken to compare 0.25% Bupivacaine with 0.375% Ropivacaine for postoperative analgesia using TAP block in caesarean section. Methods: Seventy patients were randomized into Group B (n = 35) and Group R (n = 35). TAP block was administered after completion of surgery under ultrasound guidance using 15 mL of 0.25% Bupivacaine in Group B and 15 mL of 0.375% Ropivacaine in Group R on each side of the abdomen. Time to requirement of first analgesic dosage was observed in both the groups. Total analgesic requirement in the first 24 h, visual analogue scale (VAS) scores at 2, 4, 6, 8, 12 and 24 h, patient satisfaction and complications were also noted. Results: Mean time for the first dose of rescue analgesia after completion of surgery was 298.2 ± 93.6 min in Group B and 447.6 ± 85.2 min in Group R (P = 0.0001). Total requirement of Diclofenac Sodium injection was 162.86 ± 46.88 mg in Group B whereas it was only 130.71 ± 44.49 mg in Group R (P = 0.003). VAS at 4,6 and 8 h after surgery were significantly lower in the Ropivacaine group. Conclusion: 0.375% Ropivacaine provided longer duration of analgesia and resulted in lesser analgesic requirement than 0.25% Bupivacaine when used in TAP block after caesarean section.

HISTOCHEMICAL AND IMMUNOHISTOCHEMICAL CHARACTERIZATION OF ADULT TESTES EXPOSED TO DICLOFENAC SODIUM: THE ACUTE EXPOSURE SYNDROME

Background: Diclofenac sodium is a non-steroidal anti-inflammatory medication with prostaglandin synthesis inhibiting properties. It has long been used to treat a variety of testicular problems and symptoms. However, the use of NSAIDs for specific disorders has generated some concerns due to their ability to trigger apoptosis in a variety of cells. Objective: The goal of this study was to discover if Diclofenac sodium had any effect on the reproductive function of the testes. Methods: Ten male Wistar rats (160 – 200g weight) were randomly distributed into two groups designated as groups A and B respectively. The rats in group A were injected with physiological saline while the rats in group B were given 5mg/kg Diclofenac sodium (IM) for three days. Twenty-four hours (24hrs) after the administration of the last respective dose, the rats were euthanized using Ketamine (10mg/kg IM). The testes were excised, fixed in Bouin’s fluid (48hrs), and subsequently processed according to the general techniques of tissue processing and microtomy as described by Bancroft and Gamble. Serial sections (5µm thickness) of the paraffin-embedded testicular tissue were obtained for the individual stains to be carried out. Results: Diclofenac sodium caused a considerable (p&lt;0.05) loss in body weight of the experimental rats, as well as a significant (p&lt;0.05) reduction in their sperm counts and motility, with an increase in the number of immotile sperm cells. When compared to the control group, rats given Diclofenac sodium showed a significant decrease in testicular carbohydrate, as well as decreased Ki67 and increased Cyclin D1 expression. Conclusions: Our data support the hypothesis that acute injection of Diclofenac sodium at a dose of 5 mg/kg for three days produces testicular injury and inhibits reproductive functioning. This paper discusses the immunohistochemistry effects of diclofenac sodium on testes.

Novel Self-micro Emulsifying Drug Delivery System for Safe Intramuscular Delivery with Improved Pharmacodynamics and Pharmacokinetics.

Diclofenac Sodium (DS) injection is widely used in the management of acute or chronic pain and inflammatory diseases. It incorporates 20% w/v Transcutol-P as a solubilizer to make the stable injectable formulation. However, the use of Transcutol-P in high concentration leads to adverse effects such as severe nephrotoxicity, etc. Some advancements have resulted in the formulation of an aqueous-based injectable but that too used benzyl alcohol which is reported to be toxic for human use. This study aimed to develop an injectable Self-Micro Emulsifying Drug Delivery System (SMEDDS) as a novel carrier of DS for prompt release with better safety and efficacy. A solubility study was performed with different surfactants and co-surfactants. The conventional stirring method was employed for the formulation of SMEDDS. Detailed in vitro characterization was done for different quality control parameters. In vivo studies were performed using Wistar rats for pharmacokinetic evaluation, toxicological analysis, and analgesic activity. The optimized formulation exhibited good physical stability, ideal globule size (156±0.4 nm), quick release, better therapeutics, and safety, increase in LD50 (221.9 mg/kg) to that of the commercial counterpart (109.9 mg/kg). Furthermore, pre-treatment with optimized formulation reduced the carrageenan-induced rat paw oedema by 88±1.2% after 4 h, compared to 77±1.6% inhibition with commercial DS formulation. Moreover, optimized formulation significantly (p<0.05) inhibited the pain sensation in the acetic-acid induced writhing test in mice compared to its commercial equivalent with a better pharmacokinetic profile. The above findings confirmed that liquid SMEDDS can be a successful carrier for the safe and effective delivery of DS.

Dexmedetomidine as an adjuvant for extension of postoperative analgesia in ropivacaine induced supraclavicular brachial plexus block

Pain is recognized as the fifth vital sign. The pain must be adequately treated esp. in postoperative period. The study was carried out at Department of Anesthesiology, Sri Aurobindo Institute of Medical Sciences Indore. The aim of the study was to assess the role of Dexmedetomidine in extension of post-operative analgesia. The study included 88 participants who were equally divided randomly into two groups i.e. with and without Dexmedetomidine intervention after the inclusion and exclusion criteria’s. The duration of post-operative analgesia in both groups indicating that contemplated surgery could be finished without need for additional analgesic supplement as the minimum and maximum time for surgery were within the range of effective analgesia without movement of limb. The time for demand of dose of rescue analgesic by the patients in both groups was 493.6±48.6 minutes and 961.0±141.6 minutes. The Dexmedetomidine group had a less demand of rescue analgesia. (P = 0.000). Whereas 23(52.2%) patients of Nonintervention group needed 2 to 4 doses of injection of diclofenac sodium by intramuscular route to control pain.Addition of Dexmedetomidine 100 mcg to ropivacaine 0.5% solution for conduct of supraclavicular block improved the block quality and provided prolonged postoperative pain free period and decreased the demand of systemic analgesics.

KETAMINE INFUSION FOR MANAGEMENT OF EARLY POSTOPERATIVE PAIN FOLLOWING ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY: ASSESSMENT OF OPTIMUM DOSE

Background: This study is aimed to assess an optimal dose of ketamine infusion for management of early postoperative pain in elective laparoscopic cholecystectomy. Intensity of pain, requirement of rescue analgesics and tness to discharge were assessed during immediate postoperative period. Methodology: Randomised controlled prospective clinical trial was conducted in 140 patients of laparoscopic cholecystectomy and, allocated in four groups of 35 each. Standard anaesthetic regimen was used in all patients, using propofol for induction, atracurium for muscle relaxation and isourane for maintenance of anaesthesia. Continuous infusion of the test drug was administered by intravenous cannula placed in alternate hand -1 -1 from start of port placement till wound closure. Group K1, K2 and K3 received an infusion of ketamine hydrochloride at a rate of 20 µg kg min , 30 -1 -1 -1 -1 µg kg min and, 40 µg kg min respectively, while Group N received normal saline. Postoperative pain score, requirement of rescue analgesia, degrees of sedation and postoperative cognitive function were examined postoperatively. Results: -1 Visual analog scale score ≥ 4 was considered signicant pain and, rescue analgesic injection diclofenac sodium 75mg kg was administered. Duration of analgesia was 130.71 ± 82.41, 457.14 ± 150.373, 520.97 ± 189.338 and, 524.83 ± 141.436 minutes in group N, K1, K2 and K3 respectively. Out of 35 patients 28, 4, 0 and, 0 patients required three doses of diclofenac sodium in 24 hours in N, K1, K2 and K3 group respectively. Conclusions: -1 -1 Continuous infusion of ketamine hydrochloride at a rate of 30 µg kg min during intraoperative period provide effective pain relief during early postoperative period without inuencing cognitive function of the patients.

The Surgical Treatment of Tissue Necrosis due to Diclofenac Sodium Injection (Nicolau Syndrome)

Aim: Nicolau syndrome (NS) is the necrosis of skin and subcuticular tissue, following injection of many drugs, which covers nearly a perforasome. This study aims to unveil our clinical approach and treatment alternatives against this rare pathology subsequent to diclofenac sodium.&#x0D; Material and Methods: In this retrospective study, our approach to 16 patients who developed NS at the injection site after diclofenac sodium injection was evaluated. Patients’ demographic data, concomitant diseases, location and size of necrosis, and surgical techniques were collected. Post-operative complications, hospitalization period and results were evaluated.&#x0D; Results: There were total of 16 patients, 2 of which were male and 14 were female. The mean age was 60±14.4 years, and the mean body mass index (BMI) was 33±1.4 kg/m2. The major concomitant comorbidity was diabetes mellitus, followed by primary hypertension. The mean defect size was 8x8x5 cm. Surgical debridement was applied to all 16 necrosis. Following the surgical debridement of necrosis, 8 patients were reconstructed with primary closure, 6 patients with fasciocutaneous flaps and 2 patients with delayed primary closure after a week. All patients heal completely without complications.&#x0D; Conclusion: Utmost care must be given when performing diclofenac sodium injections to the patients with comorbidities, such as high BMI, diabetes mellitus, and primary hypertension. The caregiver must be certain that the needle is in the muscular plane and no perforator vessel to be harmed during this procedure. In case of a post-injection necrosis, an early intervention with surgical debridement and reconstruction is an efficient treatment.

Development and biocompatibility assessments of poly(3-hydroxybutyrate-co-ε-caprolactone) microparticles for diclofenac sodium delivery

Osteoarthritis (OA) is a debilitating disease affecting joints and impairing the ability to perform everyday tasks. Current treatment regimens tend to provide little to no relief. Therefore, there is a huge need for alternative strategies to manage this painful condition. The delivery of anti-inflammatory drugs into an injured joint with the aim of eliminating articular inflammation and modulate cartilage damage could be a useful strategy to treat OA. Accordingly, the aim of this study is to prepare microparticles (MPs) from new biodegradable poly (3-hydroxybutyrate-co-ε-caprolactone) copolymers (PHBCL) for the potential intra-articular injection of Diclofenac sodium for OA treatment. MPs were prepared starting from copolymers having different molecular weights and an HB/CL molar ratio and studied for their morphologies and size distribution by scanning electron microscopy. Drug loading and encapsulation efficiency were also determined. The in vitro release profile was assessed by the dialysis bag technique and the kinetic profile was evaluated by using several mathematical models revealing a diffusion release mechanism. A1 polymer and related MPs, as representative of the group, were selected for further biological investigation. In vitro studies performed on CaCo-2 and Balb/3T3 cells showed no toxic effects at the desired concentrations as revealed by MTT, CFE and Comet assays.