A randomised comparative study evaluating the efficacy and tolerability of injection Diclofenac sodium 75mg/1ml given intradeltoid with injection Diclofenac sodium 75mg/3ml given intragluteal in the management of post operative pain.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 5
- 主要终点
- Intensity of post operative pain as assessed by visual analogue scale (VAS)
研究概览
简要总结
Non steroidal anti inflammatory drugs are alternatives to opioids as sole analgesic after minor surgery or as adjuvant to opioid analgesics following major surgery. One of the most commonly used NSAID for postoperative pain is diclofenac. Currently injection diclofenac is available as a 3 ml formulation and needs to be given deep intra-muscular usually intra-gluteal. A new formulation of injection diclofenac with reduced injection volume (1ml) has recently become available for clinical practice. Due to a lower injection volume it can also be given intra-deltoid. The aim of the study is to compare the efficacy and safety of the newer 1 ml formulation of injection diclofenac with the existing formulation in the management of post operative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients in the age group of 18-65 years 2.Patients of both sexes 3.Patients with healthy deltoid/ gluteal muscle mass 4.Patients undergoing operative procedures requiring hospitalization for at least 48 hours with moderate to severe pain 5.Patients with moderate to severe pain at baseline (VAS 4 -10).
排除标准
- •1.Patients below 18 years and above 65 years of age2.OPD patients/ patients requiring hospitalization less than 48 hours3.Patients with compromised renal function4.Pregnant and lactating women 5.Patients with history of bronchial asthma, peptic ulceration, bronchitis6.Patients with bleeding disorders7.Mentally retarded patients8.Unwilling patients9.Patients with known hypersensitivity to diclofenac sodium any other NSAIDs or any component of either of the study formulations10.Patients with mild baseline pain (1-3).
结局指标
主要结局
Intensity of post operative pain as assessed by visual analogue scale (VAS)
时间窗: At the end of 1, 4, 8 and 12 hours as compared to basal after each dose.
次要结局
- Pain at the site of injection as assessed by visual analogue scale (VAS)(At 1 hour and 12 hours after each dose.)
- Systemic Adverse Reactions and Rescue Medication(Upto 48 hours.)
- Global efficacy by patients and investigator.(End of Study (After 48 hrs))
- Physicians evaluation of swelling, redness and induration at the site of injection(After each dose)