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临床试验/NCT00451724
NCT00451724已完成2 期

Intranasal Ketamine for Procedural Sedation in Pediatric Laceration Repair

Rhode Island Hospital2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2007年5月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
45
试验地点
2
主要终点
Efficacy of sedation (OSBDR)

研究概览

简要总结

The purpose of this study is to compare how well three different doses of ketamine, given as a spray into the nose, help to sedate children and help them tolerate repairs of cuts on their faces.

详细描述

Procedural sedation is frequently used to facilitate distressing and painful procedures in the pediatric emergency department. However, administering an intramuscular medication or placing an intravenous line to give intravenous medications can be as distressing as the procedure itself. Oral medications generally take longer to work and are subject to first-pass metabolism. Another alternative is to give the medication by the intranasal route, which only requires a spray into the nose. Ketamine is a good sedative drug with favorable qualities, and is often used intramuscularly or intravenously. It has been used intranasally as a pre-induction by anesthetics, sedation for CT scans, and brief dental procedures, but its use has not yet been demonstrated in the setting of the pediatric emergency department for procedural sedation. We will be comparing three different doses of ketamine, applied intranasally using a mucosal atomization device, and determining if there are any differences in efficacy of sedation, time to onset of sedation, duration of sedation, caregiver and physician satisfaction, and number of adverse events. We will also use this opportunity to determine ketamine bioavailability when given intranasally using the mucosal atomization device.

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
Double

入排标准

年龄范围
1 Year 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between 1 to 7 years old
  • Simple facial laceration, defined as: linear; requiring two or more sutures; no greater than 5.0 centimeters; does not cross the lid margin of the eye; does not require a plastics/face surgery consult; occured within the last 24 hours.
  • Physician feels that intravenous sedation is required to perform the laceration repair

排除标准

  • Closed head injury, any alteration in level of consciousness, clinical suspicion of intracranial injury or increased intracranial pressure
  • Any conditions that qualify patient as American Society of Anesthesiologists' (ASA) III or IV
  • Known diagnoses of hyperthyroidism or porphyria
  • Glaucoma or penetrating eye injury
  • Hypertension
  • Any contraindication, including drug allergy, to study medications
  • Severe trauma with other injuries requiring operative intervention
  • Abnormal neurological exam in a previously normal child

结局指标

主要结局

Efficacy of sedation (OSBDR)

时间窗: 30 minutes

Time to onset of sedation (Ramsay 6-point Sedation Scale)

时间窗: 30 minutes

次要结局

  • Duration of sedation(Up to 1 hour)
  • Primary caregiver satisfaction(24 hours)
  • Physician satisfaction(Duration of procedure)
  • Ketamine bioavailability(1 hour)
  • Abnormalities in cardiopulmonary function(Until time of discharge)
  • Administration of supplemental sedative medication(During time required for procedure)
  • Prolonged sedation (i.e. > 1 hour)(Until time of discharge from emergency department)

研究者

申办方类型
Other

研究点 (2)

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