A randomized comparative study evaluating efficacy and tolerability of injection Diclofenac sodium 75mg/1ml given intradeltoid versus injection Diclofenac sodium 75mg/3ml given intragluteal in the management of post operative pain in obese patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Degree of pain relief, as assessed by a 5- point scale by patients
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 in obese patients.
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
- •Patients in the age group of 18 to 65 years Patients of both sexes Patients with BMI greater or equal to 25 Patients undergoing operative procedures requiring hospitalization for at least 48 hours Patients with moderate to severe pain at baseline VAS 4 to10.
排除标准
- •1.Patients below 18 years and above 65 years of age2.Patients with BMI < or = 253.OPD patients/ patients requiring hospitalization less than 48 hours4.Patients with compromised renal function5.Pregnant and lactating women 6.Patients with history of bronchial asthma, peptic ulceration, bronchitis7.Patients with coagulation disorders, especially bleeding disorders8.Mentally retarded patients9.Unwilling patients10.Patients with known hypersensitivity to propylene glycol, diclofenac sodium any other NSAIDs or any component of either of the study formulations11.Patients with a baseline VAS score of 3 or less than 3.
结局指标
主要结局
Degree of pain relief, as assessed by a 5- point scale by patients
时间窗: At the end of 1, 4, 8 and 12 hours as compared to basal after each dose.
次要结局
- Physicians evaluation of swelling, redness and induration at the site of injection(After each dose)
- Global efficacy by patients and investigator.(End of Study (After 48 hrs))
- Systemic Adverse Reactions and Rescue Medication(Upto 48 hours.)
- Pain at the site of injection as assessed by visual analogue scale (VAS)(At 1 hour and 12 hours after each dose.)