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临床试验/NCT00834470
NCT00834470已完成4 期

Is Atropine Needed With Ketamine Sedation?

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
140
试验地点
1
主要终点
Hypersalivation(VAS)

研究概览

简要总结

  • Ketamine seems an obvious choice in the setting of an emergency department
  • Ketamine leads to increased production of salivary and tracheal secretions
  • Antisialagogues(atropine)therefore have been recommended as a routine adjunct
  • We compare atropine with placebo as an adjunct to ketamine sedation in children undergoing primary closure of lacerated wound

详细描述

The degree of secretion was significantly less in the atropine group compared with the control group at the end of the procedure (VAS score: 16.5 ± 9.9 vs. 27.0 ± 15.9, atropine vs. control, p = 0.00). The change in the degree of secretion between the start and end of the procedure was significantly greater in the atropine group than in the control group (p = 0.00) (Fig. 2). However, the frequency of hypersalivation as predefined (VAS score ≥50) did not differ between the groups (p = 0.06).

The only complication that differed significantly between the two groups was tachycardia (p > 0.05). Complications such as aspiration, laryngospasm, and apnea were not documented in the hospital. There were fewer interventions for hypersalivation in the atropine group, but the difference was not significant (p > 0.05). As interventions, O2 administration and endotracheal intubation were not needed. After discharge, the control patients tended to have more complaints of nausea, vomiting, and ataxia, although the difference was not significant (p > 0.05) Heart rate was increased significantly in the atropine group (p = 0.00). The frequency of tachycardia according to patient age was also significantly higher in the atropine group than in the control group (p = 0.00)

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
12 Months 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric lacerated patients

排除标准

  • Contraindication of ketamine or atropine

研究组 & 干预措施

Atropine

Experimental

Atropine 0.01mg/kg IV

干预措施: Atropine (Drug)

Normal saline

Placebo Comparator

Same volume of atropine

干预措施: Atropine (Drug)

结局指标

主要结局

Hypersalivation(VAS)

时间窗: During procedure

次要结局

  • Sedation scale(before, during procedure, before discharge)
  • Pain scale(before, during procedure, before discharge)
  • Complication(during procedure and bedore discharge and 1day after discharge)
  • Satisfaction of parents and clinicians(before discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin Hee Lee

Assistant professor

Seoul National University Hospital

研究点 (1)

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