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临床试验/ACTRN12614000092695
ACTRN12614000092695已完成4 期

A randomised double-blind controlled trial of lignocaine/phenylephrine nasal spray vs placebo for pain and distress of nasogastric tube insertion in children

Dr Simon Craig0 个研究点目标入组 100 人开始时间: 2014年1月23日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
6 Months 至 5 Years(—)
性别
All

入选标准

  • Children who are (1) aged 6 months to 5 years of age AND (2) weigh at least 6kg who are due to have a nasogastric tube inserted as part of their emergency department treatment.

排除标准

  • *Inability to gain informed consent from parent or guardian
  • *Indication for an urgent insertion of a nasogastric tube
  • *Accompanying adult is non-English speaking and no interpreter service is available
  • *Child or parent has an allergy to lignocaine or phenylephrine
  • *Aberrant nasal anatomy
  • *Acute or chronic nasal problems or nasal trauma that may preclude adequate administration or absorption of intranasal medication.
  • *Cardiovascular disease / congenital heart disease – specifically hypertension, severe bradycardia, conduction disturbances and digitalis intoxication
  • *Known hepatic or renal impairment
  • *Asthma (particularly sulfite-sensitive asthma)
  • *Genetic predisposition to malignant hyperthermiaPre-existing abnormal neurological conditions
  • *Child is taking medications known to interact with Co-phenylcaine Forte (Antiarrhythmic drugs;Suxamethonium; Phenytoin;Antidepressants; Propranolol;)Citicoline

研究者

发起方
Dr Simon Craig

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