Atomized Intranasal Vs Intravenous Ketorolac in Acute Renal Colic Pain Management: A Randomized Controlled Double-blinded Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Analgesic effects of Intranasal Ketorolac on the visual analog scale (VAS)
研究概览
简要总结
Introduction: Pain is a common reason for individuals to seek health care, especially emergency care. Ketorolac has numerous advantages over other pain medications, especially the opioids. The intranasal administration of ketorolac has been shown to be safe and effective in the treatment of postoperative pain following major abdominal surgery and post dental surgery, but there have been no studies evaluating the use of intranasal ketorolac for the treatment of acute renal colic pain in the emergency department.
Methods: This is a double blinded randomized controlled trial. two hundred renal colic patients presented to the emergency department will be randomized to intervention (30 mg intranasal ketorolac) and (30mg intravenous ketorolac) case groups. Their pain before and after receiving ketorolac will be measured by visual Analog Scale (VAS pain score). Patient, attending physician and administering nurse will be blinded throughout the study. The analgesic effects will be assessed by several measures including pain relief, pain intensity difference, global pain evaluation, global assessment of analgesia, and the summed pain intensity difference. The safety will be assessed by documentation of adverse events, vital signs, and clinical assessment before and after drug administration.
Aim: The aim of this study is to compare analgesic effects of intranasal Ketorolac tromethamine versus intravenous Ketorolac tromethamine in adult patients with moderate to severe renal colic.
Primary Objective: Analgesic effects of Intranasal Ketorolac on the visual analog scale (VAS).
Secondary Objectives: Adverse Events, the need of rescue pain medications, time to discharge and recurrent visit within 24 hours.
Patient Population: Adults (from age 18 to 64 years) who presents to emergency department (ED) at Sultan Qaboos University Hospital with moderate to severe acute flank pain suggestive of renal colic (visual analog scale 7 or more).
Intervention: Single dose of intranasal ketorolac 30mg.
Clinical measurement: Visual Analog Scale will be assessed at 0, 30 and 60 minutes after intervention. Number and dosage of rescue medication, any reported events by patient or attending physician will be documented.
Outcome: Decrease in pain measures by VAS pain score after intranasal ketorolac is given, tolerability and safety evaluation.
详细描述
Research objectives and hypothesis:
The aim of this study is to compare the analgesic effects of intranasal Ketorolac tromethamine versus intravenous Ketorolac tromethamine in adult patients with moderate to severe renal colic seen at the Emergency Department at Sultan Qaboos University Hospital.
Study design:
Prospective double-blinded randomized clinical trial in adults (from age 18 to 64 years) who presents to the emergency department (ED) at Sultan Qaboos University Hospital with moderate to severe acute flank pain suggestive of renal colic (visual analog scale 7 or more). Written consent will be obtained from the patient. Eligible subjects will be enrolled (see section 5).
Control Group Will receive 30 mg intravenous ketorolac in 10 ml syringe + 1 ml Normal Saline 9% using the intranasal device (0.5 ml in each nostril).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with classical acute renal colic symptoms.
- •Age ≥ 18 years and < 65 years
- •Stable patient with stable vital signs.
- •Mentally competent patient who can understand and sign the consent form.
- •Pain score is moderate to severe (visual analog scale 7 or more).
排除标准
- •Patients who are allergic to ketorolac.
- •Patients with active peptic ulcer disease.
- •Patients with a history of asthma, urticaria, or other allergic-type reactions after taking NSAIDs.
- •Patients with renal disease and renal transplant.
- •Patients who are at risk for renal failure due to volume depletion.
- •Pregnant or nursing mothers.
- •Patients with any other contraindication to the use of ketorolac, or in whom the use of ketorolac would not be consistent with the approved package insert.
研究组 & 干预措施
intravenous
30 mg intravenous ketorolac in 10 ml syringe + 1 mL Normal Saline 9% using an intranasal device (0.5 ml in each nostril).
干预措施: Intravenous Ketorolac Tromethamine (Drug)
Intranasal
30 mg intranasal ketorolac in 1 ml intranasal device (0.5 ml in each nostril) + 10 ml Intravenous Normal Saline 9%.
干预措施: Intranasal Ketorolac Tromethamine (Drug)
结局指标
主要结局
Analgesic effects of Intranasal Ketorolac on the visual analog scale (VAS)
时间窗: At 30 and 60 minutes
Change in visual analog scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain).
次要结局
- The need of rescue pain medications.(60 min During Emergency Visit)
- Time to discharge.(within 24 hours.)
- Adverse Events/Side Effects.(48 hours)
- Recurrent visit(within 24 hours.)
研究者
Usama Al-Khalasi
Emergency Medicine Resident
Oman Medical Speciality Board