Atomized Intranasal Ketorolac at 30 mg Versus 20 mg for the Treatment of Acute Pain in the Emergency Department: A Randomized Non-inferiority Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Pain score at 30 minutes
研究概览
简要总结
This study aims to compare the analgesic effectiveness and side effects of intranasal ketorolac at 30 mg Versus 20 mg for the Treatment of Acute moderate and severe Pain in the Emergency Department.
详细描述
Pain control is one of the problems in emergency departments (EDs). Analgesics in the intranasal (IN) form have been come into interest and focus because of their ease of application and effectiveness. Recently, IN ketorolac at 30mg has been turned out to have comparable efficacy with parenteral forms. Considering the ceiling effect of the ketorolac, this trial will study whether lower dose of 20mg for pain management is equally effective as 30mg dose.
The study is a multicenter, prospective, randomized, double blind, parallel group non inferiority clinical trial conducted in three EDs. Eligible participants are adults aged 18-65 years presenting with acute moderate to severe pain [numeric rating scale (NRS)≥4]. Participants will be randomized to receive atomized IN ketorolac 20 mg or 30 mg. Primary outcome is change in pain reduction at 30 minutes post administration. Secondary outcomes include pain reduction at 15, 45, and 60 minutes, requirement for rescue analgesia (IV morphine 0.1 mg/kg available at 30), gastrointestinal and other adverse effects, and patient satisfaction.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 years
- •Weight > 50 kg
- •Able to provide informed consent
- •Acute pain (<48 hours) with verbally administered NRS≥4 (0-10 range, 0 = no - pain and 10 = worst imaginable pain)
排除标准
- •Active peptic ulcer disease (PUD)
- •History of hypersensitivity to NSAIDs
- •Pregnancy and breastfeeding
- •Renal failure
- •Hepatic failure
- •Patients who have received analgesics within the past 6 hours
- •Nasal congestion
- •Upper respiratory tract infection
- •Patients with a history of kidney transplantation
- •Active gastrointestinal bleeding
- •Systolic blood pressure less than 90 mmHg or greater than 180 mmHg
- •Heart rate less than 50 per minute or greater than 150 per minute
- •Concurrent use of NSAIDs or anticoagulant drugs
- •Inability to provide informed consent
- •Anatomical abnormalities of the nose or skull base (congenital or acquired)
- •Hyperreactive airway disease such as severe asthma
- •Coagulation disorders
- •Intracranial hemorrhage
- •Suspected aortic dissection
- •Suspected rupture of abdominal aortic aneurysm
- •History of gastrointestinal perforation
- •Gastrointestinal bleeding within the past month
- •Chronic pain disorders
- •Substance misuse
- •Immediate opioid necessity
- •Altered mental status
- •Any pain that is considered to be not appropriate for receiving NSAIDS by emergency physician
研究组 & 干预措施
30mg Intranasal Ketorolac
30 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril
干预措施: 30mg Intranasal Ketorolac (Drug)
20mg intranasal ketorolac
30 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril.
干预措施: 20mg intranasal ketorolac (Drug)
结局指标
主要结局
Pain score at 30 minutes
时间窗: 30 minutes post-administration
Numerical Rating Scale (NRS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain (worse outcome)
次要结局
- Need for rescue analgesia(30 minutes post-administration)
- Side effects(From the drug administration to 60 minutes afterward)
- Pain score at 15 minutes(15 minutes post-administration)
- Pain score at 45 minutes(45 minutes post-administration)
- Pain score at 60 minutes(60 minutes post-administration)
- Nasal irritation(60 minutes after the drug administration)
- Patient satisfaction score(60 minutes after the drug administration)
研究者
Hadi Mirfazaelian
Associate Professor
Tehran University of Medical Sciences