Ethanolamine oleate 5% solution for injection 2ml ampoules

Background: Benign oral vascular lesions are abnormalities defined by the proliferation or malformation of blood vessels. The appearance of vascular lesions varies according to age and anatomical location. There are no criteria to evaluate its therapeutic effectiveness. Treatment with the sclerosing drug ethanolamine oleate irrigates the vessel, causing a sterile inflammatory response. Objectives: This article provides an overview of the effectiveness and complication of ethanolamine oleate in the management of oral and perioral benign vascular lesion. Methods: This article is based on a comprehensive literature search, identifying relevant articles using Ovid, PubMed, and Google Scholar. The data mainly involve a critical review of various studies from sample groups of different ethnicities, age groups, and gender, were evaluated. Findings: Hemangiomas and vascular malformations are among the many disorders that can cause vascular lesions of the head and neck. When vascular lesions are producing pain or symptoms, they need to be treated. Systemic and intralesional steroids, intralesional sclerosing drugs, interferon, laser therapy, embolization, cryotherapy, and radiation are some of the therapeutic approaches and techniques that have been suggested for the treatment of vascular lesions. As a primary amine and a primary alcohol, ethanolamine oleate is an organic chemical molecule that, when injected into tissues, can result in a dose-related inflammatory response that causes fibrosis and a reduction in the size of lesions. The most affected age group was between 41 and 70 years (mean age: 47 years, range: 4-87 years). The female gender was predominant (56%), and 86% of patients were Caucasian. Half of the patients reported the presence of a lesion (complaint period) lasting longer than 5 years. Regarding the location, there was a higher rate of occurrence on the lips (70%) followed by the tongue (16%) and buccal mucosa (14%). According to the clinical appear­ance of the lesions, approximately 90% were classified as nodules. A total of 41% of the lesions were between 0.5 cm and 1.0 cm in size (Table 1). Swelling was the most common type of complaint, reported by 28 patients (65%) followed by color alteration (7 patients, 16%). Most patients reported no pain (90%). Con­cerning the clinical diagnostic hypothesis, 40 lesions were defined as hemangiomas and vascular malforma­tions (93%) and 3 as varices (7%). Only one session of one application of 5% EO was suf­ficient to obtain a satisfactory result in 58% of the pa­tients. The regression of the lesions usually occurred in 2 to 3 weeks after the application. Regarding the lesions larger than 1.0 cm, 6 cases received a total dose of 0.4 to 0.7ml of EO, 9 cases received 0.8 to 2.0 ml, and 4 cases received more than 2.0 ml. Conclusion: Ethanol Amine Oleate Sclerotherapy is a less intrusive and safe technique that is simple to repeat and poses little risk to the patient. Some individuals may experience procedure-related side effects, such as induration, edema, discomfort, and cutaneous or mucosal blisters at the injection site. These issues are mild, though, and should go away in three to four days.

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Introduction: Sclerotherapy is a well-established treatment option for oral vascular anomalies. Ethanolamine Oleate is widely used as a sclerosing agent for oral vascular malformation, especially low flow venous lesions, however, pain is one of the most common postoperative complications. Therefore, Ethanolamine Oleate with an anesthetic agent may help in reducing postoperative pain in cases of oral venous malformation.Aim of the study: This study aimed to compare the effect of Ethanolamine Oleate as a sclerosing agent for oral venous malformation with and without an anesthetic agent in reducing postoperative pain and resolution of the lesion.Materials and Methods: 16 patients with oral venous malformation were recruited and randomly allocated into two equal groups. Sclerotherapy with Ethanolamine Oleate was performed for all patients in Group A (Control Group) eight patients were injected with Ethanolamine Oleate alone and for Group B (Study Group) eight patients were injected with Ethanolamine Oleate mixed with Lidocaine.Results: There was a statistically significant decrease between the two studied groups. Conclusion: This study confirmed the positive effect of intralesional injection of EO and Lidocaine in OVMs regarding postoperative pain and resolution of the lesion.

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Background: Venous malformations (VMs) are a variety of low flow vascular malformations, which are developmental error of morphogenesis of veins where veins are dysplastic lined by quiescent or normal endothelium. Although surgical extirpation is the standard method for the treatment of vascular malformations, this procedure often leads to significant loss of motor function, nerve damage, or massive bleeding in patients which may endanger the life. Therefore, sclerotherapy has now been accepted as a less invasive alternative and good results have been obtained. Objectives: This study was conducted to evaluate the clinical outcomes after Foam sclerotherapy with injection Ethanolamine Oleate (EO) for the treatment of VMs in head-neck region. Methods: This quasi-experimental study was conducted in the Department of Otolaryngology- Head & Neck Surgery, Bangabandhu Sheikh Mujib Medical University (BSMMU). Forty-three patients with venous malformation in head neck region that had the inclusion criteria were enrolled as a study sample. The patients were diagnosed mostly clinically & confirmed by demonstrating non-pulsatile blood flow and venous space using Duplex ultrasound. The sclerosing solution 5% Ethanolamine Oleate (EO) was used in this study. Sclerofoam was produced using the Tessari method in 4:1 air to liquid ratio, the foam had been used within 60- 90 seconds. Results of the study were categorized as excellent, good, fair and poor. Ethical clearance was obtained from the Institutional Review Board (IRB) of BSMMU. Results: Among 43 patients 34(79.1%) patients underwent single session and 9(20.9%) were two sessions. All the lesions were responded to EO. Response to sclerotherapy categorized as excellent were in two third 29 (67.4%) patients and 14 (32.6%) had good response. No sessions resulted in poor responses. No complications occurred following any procedures. All of the sessions were performed as a day case basis without anesthesia. Conclusions: Foam sclerotherapy with injection EO appears to be safe and effective for the treatment of VMs in the head and neck region and should be considered when treating these complex lesions. Bangladesh J Otorhinolaryngol; October 2020; 26(2): 79-85

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OBJECTIVE: To evaluate the effect and safety of sclerotherapy in patients with difficult-to-resect venous malformations treated with ethanolamine oleate. DESIGN AND SETTING: This investigator-initiated clinical trial employed a multicenter, single-arm design and was conducted in Japan. PATIENTS: Overall, 44 patients with difficult-to-resect venous malformations were categorized into two cohorts: 22 patients with cystic-type malformations and 22 patients with diffuse-type malformations, including children (<15 years old). INTERVENTIONS: Adult patients received injections of 5% ethanolamine oleate solution, double diluted with contrast or normal saline, with a maximum dose of 0.4 mL/kg. The same method of administration was used for children (<15 years old). The maximum volume of the prepared solution in one treatment was 30 mL. EVALUATION METHODS: Treatment effect was assessed by evaluating the difference in lesion volume using magnetic resonance imaging as a primary endpoint and differences in pain using a visual analog scale as a key secondary endpoint. RESULTS: Among the 45 patients who consented, one was excluded owing to potential intracranial involvement of venous malformations during screening. Regarding the primary outcome, 26 of 44 patients (59.1%, 95% confidence interval: 44.41-72.31%) achieved ≥ 20% reduction in malformation volume, with 16 patients having cystic lesions (72.7%, 51.85-86.85%) and 10 patients having diffuse lesions (45.5%, 26.92-65.34%). Both cohorts showed significant improvement in self-reported pain scores associated with lesions 3 months post-sclerotherapy. No death or serious adverse events occurred. Hemoglobinuria was observed in 23 patients (52%), a known drug-related adverse event. Prompt initiation of haptoglobin therapy led to full recovery within a month for these patients. CONCLUSIONS: Ethanolamine oleate shows potential as a therapeutic sclerosing agent for patients with difficult-to-resect venous malformations.

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