ACTRN12612000012875已完成4 期
A dose-finding study assessing the effectiveness of sub-dissociative doses of intranasal ketamine in the treatment of moderate to severe acute pain in the emergency department in children. Part One of a two-part study protocol.
Southern Health0 个研究点目标入组 60 人开始时间: 2012年1月4日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 3 Years 至 13 Years（—）
- 性别
- All
入选标准
- •Children aged three to 13 years and under 50kg body weight
- •Musculoskeletal injury to upper and/or lower limbs
- •Visual analog pain score greater than or equal to 6/10 on the standard 11-point verbal rating scale (0 = none, 10 = worst pain imaginable) and patient would normally be considered for intranasal fentanyl administration.
- •Use of simple analgesia such as paracetamol or ibuprofen or inhalational methoxyflurane during ambulance transport are not exclusion criteria
排除标准
- •Inability to gain informed consent from parent or guardian
- •Prior administration of parenteral or intranasal analgesics (morphine, fentanyl)
- •Prior administration of oral opioid analgesia (oxycodone, codeine)
- •Allergy to ketamine
- •Aberrant nasal anatomy
- •Acute or chronic nasal problems or nasal trauma that may preclude adequate administration or absorption of intranasal medication.
- •Presence of multiple trauma or injuries.
- •Sustained a head injury with loss of consciousness.
- •Presence of cognitive impairment.
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