Intranasal Ketorolac Effectiveness In Comparison To Intranasal Ketamine for Digital Nerve Block Pain; A Randomized, Double Blind Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 64
- 主要终点
- Block pain intensity
研究概览
简要总结
This study aims to compare the analgesic effectiveness and side effects of intranasal ketorolac versus intranasal ketamine for reducing pain prior to digital nerve block procedures in patients with finger injuries in emergency department.
详细描述
Acute pain management in emergency department during painful procedures such as digital nerve block is crucial to be implemented in a rapid-onset method. Ketorolac, a potent NSAID, and ketamine, an NMDA receptor antagonist with analgesic effects, have both been shown to be effective and fast-onset when administered intranasally. This non-invasive method of Ketorolac is not supported by sufficient evidences in such clinical scenarios. Addressing this research gap may lead to reduced pain and complications, as well as higher patient satisfaction, contributing the development of novel pre-procedural analgesic strategies in emergency settings.
Participants will be randomly assigned to receive either 30 mg intranasal ketorolac or 50 mg intranasal ketamine, administered 5 minutes prior to the digital nerve block. Pain will be assessed using the Numeric Rating Scale (NRS). Secondary endpoints include nasal irritation, side 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
- •Requires digital nerve block
- •Able to provide informed consent
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
研究组 & 干预措施
Intranasal Ketamine
50 mg ketamine will be administered intranasally using mucosal atomizer,. Half dose (0.5cc) in each nostril, Given 5 minutes before digital nerve block
干预措施: Intranasal ketamine (Drug)
Intranasal Ketorolac Tromethamine
30 mg ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril, Given 5 minutes before digital nerve block.
干预措施: Intranasal Ketorolac Tromethamine (Drug)
结局指标
主要结局
Block pain intensity
时间窗: Immediately after block
The numerical rating score (NRS) will be used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). The higher the pain scores the higher the pain severity. The pain severity will be asked from the patients.
次要结局
- Nasal irritation(60 minutes after the block)
- Side effects(From the drug administration to 60 minutes after the block)
- Patient satisfaction score(60 minutes after the drug administration.)