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临床试验/NCT02801292
NCT02801292Unknown3 期

Ketamine as an Adjuvant Therapy for Acute Vaso Occlusive Crisis in Pediatric Patients With Sickle Cell Disease, a Pilot Study

Augusta University0 个研究点目标入组 20 人开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
20
主要终点
pain score

研究概览

简要总结

The primary objective of the proposed study is to determine the potential role of Ketamine as an analgesic agent in pediatric sickle cell disease patients with refractory symptoms in acute (VOC).

详细描述

The primary objective of the proposed study is to determine the potential role of Ketamine as an analgesic agent in pediatric sickle cell disease patients with refractory symptoms in acute (VOC). Our study design is as follows: Prospective observational study of 20 pediatric sickle cell disease patients with refractory pain to conventional analgesic regimens seen in the pediatric emergency medicine department. Consenting patients with refractory pain meeting inclusion criteria will be given a single intravenous bolus of Ketamine at a set dosage of 0.25 milligrams per kilogram of weight. Participants' perception of pain will then be recorded using standard pain scoring scales (FLACC score). Physiologic criteria such as heart rate, blood pressure, blood oxygen saturation, total analgesic pharmacologic requirements for adequate analgesia during hospitalization, and duration of hospitalization will be measured. Observational study group will continue to get standard of care outside of single bolus of Ketamine. 48 hour follow up after hospital discharge will be obtained to assess degree of pain control and general clinical status.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients (> 3 yrs and <18yrs) with a previous diagnosis of sickle cell disease (including Hgb S Beta Thalassemia +, Hgb S Alpha Thalassemia, Hgb S HPFH) ) seen in the pediatric emergency room setting for acute vaso-occlusive pain crisis.

排除标准

  • Patients not to have sequelae indicative of complicated disease outside of acute VOC:
  • Acute chest syndrome (new pulmonary infiltrate and hypoxemia)
  • Aplastic Episode
  • Evidence of infection
  • Pregnancy or CHF
  • Fever (> 38.4)
  • Cholangitis or cholecystitis
  • Hypoxia (SaO2 <90% on RA), or O2 saturation decrease of more than 5% from patient's baseline
  • Unstable Vital Signs
  • Patients who have received intravenous pain medicine within 24 hours of visit to the emergency department.
  • History of allergic reaction or serious reaction to Ketamine.
  • History of significant psychiatric illness
  • Patients with no refractory pain after receiving conventional analgesia regimen per protocol.

研究组 & 干预措施

administering of ketamine

Other

adjuvant to standard of care

干预措施: Ketamine (Drug)

结局指标

主要结局

pain score

时间窗: 1 hour

reduction in refractory pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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