To determine the efficacy and safety of intravenous Ketorolac tromethamine versus Tramadol in adults with acute renal colic presenting to the emergency department: A randomized controlled trial-single blinded.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the pain score at 30 and 60 minutes post administration of intravenous Ketorolac and Tramadol to patients with acute renal colic presenting to the Emergency department
研究概览
简要总结
This randomized, single blinded, phase IV superiority trial will compare the analgesic efficacy and safety of intravenous Ketorolac tromethamine versus intravenous tramadol for acute renal colic in the emergency department (ED). Adults greater than or equal to 18 years with suspected renal colic and baseline moderate-to-severe pain (Numeric Rating Scale [NRS] greater than or equal to (4) will be enrolled after informed consent. Participants will be randomized 1:1 by computer-generated sequence with allocation concealed using sequentially numbered, opaque, sealed envelopes. The study will enroll 100 participants (50 per arm), providing 90 percent power (alpha=0.05) to detect the prespecified difference in pain-score change. Analyses will follow intention-to-treat the primary endpoint will be compared using chi-square or Fisher’s exact with risk ratio, risk difference, and 95 percent CIs, with adjusted models as sensitivity analyses. The trial will obtain IRB approval and registration before enrolment; post-trial, all participants will continue to receive best available standard care. Tramadol is the standard of care in Emergency department. There is minimal studies in comparing IV Ketorolac and tramadol hence we want to carryout this study in Emergency department.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult patients(Patients more than 18 years of age) 2.Patients with suspected acute renal colic presenting to the ED(typical colicky flank pain and with or without hematuria) with plan for imaging per standard care.
- •3.patients with moderate to severe pain at baseline(e.g.NRS more than or equal to 4/10 4.Patients willing to provide informed written consent to participate in the study.
排除标准
- •Patients with known allergy or hypersensitivity to NSAIDs, opioids or study drugs Patients with history of peptic ulcer disease, gastrointestinal bleeding or known coagulopathy, platelet count 1 lakh per liter therapeutic anticoagulation where NSAIDs are contraindicated.
- •Severe renal impairment (eGFR Less than 30ml per min per 1.73 meter square) or known CKD stage 4-
- •pregnant or lactating women.
- •Hemodynamic instability ( SBP less than 90 mm HG) or altered mental status precluding consent or assessment.
- •An alternative non renal colic diagnosis judged more likely on ED assessment (AAA, Appendicitis, ectopic pregnancy ).
结局指标
主要结局
To compare the pain score at 30 and 60 minutes post administration of intravenous Ketorolac and Tramadol to patients with acute renal colic presenting to the Emergency department
时间窗: 30min 60min 90min 120min and 150min
次要结局
- a. To determine the adverse effects of intravenous Ketorolac and Tramadol in patients with acute renal colic presenting to the Emergency department(b. To determine the need for rescue analgesia between groups.)
研究者
DR R Kaveri
Christian medical college Vellore-632004