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临床试验/ACTRN12617001490369
ACTRN12617001490369已完成1 期

Palatable and chewable tramadol chocolate-based tablets for pain management in paediatric patients

Princess Margaret Hospital0 个研究点目标入组 147 人开始时间: 2017年10月23日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
147

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
Open (masking not used)

入排标准

年龄范围
3 Years 至 16 Years(—)
性别
All

入选标准

  • •Male or female, 3 to 16 years of age
  • •Treating anaesthetist considering patient suitable for pre-procedural tramadol
  • •Obtained informed parental or guardian consent and child assent where appropriate

排除标准

  • •Known allergy to chocolate (chocolate base does not contain nuts)
  • •Known allergy/intolerance to tramadol or opioids
  • •Unable to understand the information sheet and the consent form
  • •Patient taking medication known to interact with tramadol (e.g. serotonergic agents, warfarin, ketoconazole)
  • •Known significant renal or hepatic impairment
  • •Known seizure disorder or epilepsy
  • •Participants undergoing surgeries that remove the tonsils or adenoids.
  • •Obese (as detailed by a BMI percentile above the 95th)
  • •Known severe obstructive sleep apnoea as documented by an overnight sleep study
  • •Known severe respiratory disease with significant impact on daily life

研究者

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