Efficacy and Safety of Intramuscular Etoricoxib vs Diclofenac Sodium Injections in the Management of Acute Orthopedic Pain - A Randomized Open Label Pilot Study.
试验速览
- 阶段
- 4 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1. To evaluate the effectiveness and safety of IM etoricoxib injection 90 mg/mL over Diclofenac sodium 75mg/ml in the management of patients with acute orthopaedic pain.
研究概览
简要总结
India is shifting towards the phase of epidemiological transition where ageing and chronic disorders are at its peak which eventually results in the limitation of quality of life . The studies shows that the different range of orthopedic pain which is so common that it is reported by all age group of people during their period of life. In the year 2008, the esteemed Drug Controller General of India granted approval for the IM etoricoxib injection, formulated at a concentration of 90 mg per mL, to be administered for the alleviation of short-term acute painful conditions in adults.
Furthermore, IM injection can be particularly beneficial for patients who cannot tolerate or effectively absorb oral medications. As the global population ages, the prevalence of pain conditions, such as osteoarthritis, neuropathy, and other musculoskeletal disorders, is increasing, necessitating the frequent use of pain-relieving medications. pain-relieving medication, it is crucial to consider the potential misuse of these drugs. With this novel route of administration, the frequency of drug administration can be minimized, potentially reducing the cost of a single dose. COX-1-derived prostanoids are essential for ‘housekeeping ‘functions throughout the body and especially in the GI tract, kidney and platelets. PGE2 , for example, is recognised as an essential component for the maintenance of gastrointestinal mucosal integrity which it orchestrates by maintaining sub-mucosal blood flow, amongst other actions.
This study compares the efficacy and safety of intramuscular etoricoxib (90 mg/mL) versus diclofenac sodium (75 mg/mL) for managing acute orthopedic pain. It is a randomized, open-label pilot trial involving 70 patients aged 18-60 with conditions like fractures, arthritis, or sprains. Pain relief is measured using the Visual Analog Scale (VAS) at 30 and 60 minutes post-injection. The primary goal is to determine if etoricoxib provides faster or better pain relief than diclofenac, while secondary objectives assess safety and side effects. The study aims to establish IM etoricoxib as a viable alternative with fewer gastrointestinal risks compared to traditional NSAIDs like diclofenac. Ethical approvals and informed consent are secured.
This study has the primary goal to evaluate the safety and efficacy of IM etoricoxib and IM diclofenac sodium in patients with acute orthopaedic pain. To access the symptoms relief using pain scale based on the effect of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with knee arthritis, fractures, back pain and back injury, muscle strain or sprain, torn ligament and also with the other orthopaedic inflammatory conditions.
排除标准
- •Patient with history of clinically significant cardiovascular diseases including hypertension, hepatic dysfunction, renal impairment, GI problems like peptic ulcer, GI bleeding of perforations and cerebrovascular issues.
- •Pregnancy and lactation.
- •Patients using drugs like NSAIDS, Diuretics, Anti coagulants, Rifampicin, Immunosuppressants, ACE inhibitors, ARBs, Lithium, Birth control pills and Digoxin.
结局指标
主要结局
1. To evaluate the effectiveness and safety of IM etoricoxib injection 90 mg/mL over Diclofenac sodium 75mg/ml in the management of patients with acute orthopaedic pain.
时间窗: 1. To evaluate the effectiveness and safety of IM etoricoxib injection 90 mg/mL over Diclofenac sodium 75mg/ml in the management of patients with acute orthopaedic pain. | 2. To identify the efficacy of IM etoricoxib over the Diclofenac at 30 minutes and 60 minutes using Visual Analog scale (VAS)
2. To identify the efficacy of IM etoricoxib over the Diclofenac at 30 minutes and 60 minutes using Visual Analog scale (VAS)
时间窗: 1. To evaluate the effectiveness and safety of IM etoricoxib injection 90 mg/mL over Diclofenac sodium 75mg/ml in the management of patients with acute orthopaedic pain. | 2. To identify the efficacy of IM etoricoxib over the Diclofenac at 30 minutes and 60 minutes using Visual Analog scale (VAS)
次要结局
- 1. To assess the safety of IM etoricoxib over the Diclofenac injections.(2. To assess for any allergic reactions or side effects.)
研究者
S S PRAVIN
SRM College of Pharmacy
