跳至主要内容
临床试验/NCT03466242
NCT03466242撤回早期 1 期

IN Dexmedetomidine for Procedural Sedation in Pediatric Closed Reductions for Distal Forearm Fractures. Timmons Z MD, Feudale B MD Children Presenting to the ED With Distal Forearm Extremity Fractures Often Require Re-alignment Under Conscious Sedation. The Objective of This Study is to Evaluate the Sedative, and Analgesic Effects of Intranasal (IN) Dexmedetomidine (DEX) Who Undergo Conscious Sedation for Reduction of Closed Distal Forearm Fractures When Compared to Those Receiving the Standard of Care Intravenous (IV) Ketamine

Phoenix Children's Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
撤回
入组人数
40
试验地点
1
主要终点
Evaluate the analgesic effects of intranasal Dexmedetomidine in children undergoing conscious sedation for closed distal forearm fracture reduction compared to intravenous Ketamine

研究概览

简要总结

The primary objective of this study is to evaluate the sedative, and analgesic effects of intranasal (IN) Dexmedetomidine (DEX) in children presenting to a Pediatric Emergency Department (PED) who undergo conscious sedation for reduction of closed distal forearm fractures when compared to those receiving intravenous (IV) Ketamine. The secondary objective is to compare each sedation technique for safety and procedural outcomes.

详细描述

Distal Forearm fractures are often are displaced requiring conscious sedation for closed reduction in the Emergency Department. Our institution's current standard of care consists of IN Fentanyl for baseline control of pain, and for those fractures requiring reduction; typically IV Ketamine is utilized. Ketamine is typically well tolerated but is not without concerns including hypertension, vomiting, and the rare but serious complication of laryngospasm. Dexmedetomidine (DEX) offers a possible alternative to IV Ketamine. DEX has been used safely in the critical care setting for both pediatrics and adults. It has been well documented as being quite effective in sedation, amnesia and analgesia. Using IN DEX for PED procedural sedation has the potential to obviate the need for IV placement and may offer a better conscious sedation profile than Ketamine with respect to sedation, analgesia, and adverse outcomes.

Our overall project would be to assess the efficiency of IN DEX in comparison to IV Ketamine, for proper sedation and analgesic coverage for children undergoing closed reduction of distal forearm fractures.

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
None

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Verbal children aged 2-18 with a single extremity displaced forearm fracture requiring conscious sedation and reduction will be screened for enrollment.

排除标准

  • Under age 2 years old or patients > 18 years old
  • Multiple Fractures
  • Significant multisystem trauma
  • Glasgow Coma Scale (GCS < 15)
  • Complex fractures that aren't deemed reducible in ED
  • Reported Allergy to Alpha -2-agonists
  • Intoxication
  • Baseline Hypotension as < 70mm Hg + 2 x age or < 90mm Hg for patients > 11 years of age
  • Patients with prior reductions attempted at outside facilities
  • Aberrant nasal anatomy that precludes IN medications
  • Chronic Health issues that can affect DEX metabolism
  • History of adverse reactions to anesthesia
  • Patients transferred from outside facilities
  • Open fractures

研究组 & 干预措施

IV Ketamine

Active Comparator

Evaluate sedative and analgesic effects of Intravenous Ketamine (1mg/kg)

干预措施: Ketamine (Drug)

Intranasal Dexmedetomidine

Experimental

Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine (1-2ug/kg)

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Evaluate the analgesic effects of intranasal Dexmedetomidine in children undergoing conscious sedation for closed distal forearm fracture reduction compared to intravenous Ketamine

时间窗: 12 months

The analgesic effects of intranasal Dexmedetomidine will be compared to intravenous ketamine for conscious sedation using either the Wong-Baker scale (FACES) or Visual Analogue Scale (VAS) depending on patient age and developmental status

Evaluate the sedative effects of intranasal Dexmedetomidine in children undergoing conscious sedation for closed distal forearm fracture reduction compared to intravenous Ketamine

时间窗: 12 months

The sedative effects of intranasal Dexmedetomidine will be compared to intravenous ketamine for conscious sedation via the Michigan Sedation Scoring (MSS) system.

次要结局

  • Compare each sedation technique for length of ED stay(12 months)
  • Compare each sedation technique for rate of vomiting(12 months)
  • Compare each sedation technique for length of sedation(12 months)
  • Compare each sedation technique for procedural success rate(12 months)
  • Compare each sedation technique for need for additional doses of medications for analgesia or sedation(12 months)
  • Compare each sedation technique for need for respiratory interventions(12 months)
  • Compare each sedation technique for time to sedation onset(12 months)
  • Compare each sedation technique for Vital sign abnormalities(12 months)
  • Compare each sedation technique for patient family satisfaction(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验