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临床试验/NCT06219967
NCT06219967已完成4 期

Does a Soft Drink Mixture Improve Tolerance of Activated Charcoal in the Adult Poisoned Patient Without Affecting Efficacy: A Randomized Crossover Trial

State University of New York - Upstate Medical University1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2023年1月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
5
试验地点
1
主要终点
Absorption of Acetaminophen as Indicated by Area Under the Curve

研究概览

简要总结

Activated charcoal (AC) is an established, effective means of gastrointestinal decontamination. Providers give it to patients who have ingested something that is thought to be potentially poisonous to prevent it from being absorbed. However, one limitation to its use is palatability of the AC for the patient, potentially limiting how much, if any, is taken.

Other studies have suggested that mixing AC with various substances improves the rating on various scales (taste, etc). An important question is whether mixing the AC with other substance effects the ability of the AC to bind to xenobiotic in the gut. This small study investigates whether mixed cola with charcoal affected its ability to prevent the absorption of acetaminophen. It also performs a survery to see if participants preferred the AC-cola mixture. The investigators hypothesize that the AC will be equally as effective with cola as without. The investigators also hypothesize that participants will prefer the AC-cola mixture.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • No self-reported history of any hepatic, gastrointestinal, or renal disease
  • No self-reported history of alcohol or substance use disorder
  • No daily prescribed medications
  • Weight between 60-93 kg

排除标准

  • pregnant,
  • imprisoned
  • allergy or intolerance to acetaminophen or gluten

研究组 & 干预措施

Activated charcoal with cola

Experimental

干预措施: Activated Charcoal (Drug)

Activated charcoal

Active Comparator

干预措施: Activated Charcoal (Drug)

结局指标

主要结局

Absorption of Acetaminophen as Indicated by Area Under the Curve

时间窗: 240 minutes

Measure of the area under the curve of the acetaminophen concentration vs time curve. Values obtained at 0, 15, 30, 45, 60, 75, 90, 120, 180, and 240 minutes were used to produce the curve

Time to Maximum Concentration of Acetaminophen

时间窗: 240 minutes

Time of maximum concentration of acetaminophen (minutes)

Maximum Concentration Acetaminophen

时间窗: 240 minutes

Maximum concentration of acetaminophen (mcg/mL)

次要结局

  • Appeal of Charcoal Mixture(5 minutes)
  • Flavor of Charcoal Mixture(5 minutes)
  • Texture of Charcoal Mixture(5 minutes)
  • Overall Appeal of Charcoal Mixture(5 minutes)
  • Smell of Charcoal Mixture(5 minutes)

研究者

发起方
State University of New York - Upstate Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Keenan

Assistant Professor Emergency Medicine

State University of New York - Upstate Medical University

研究点 (1)

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