ACTRN12617001490369已完成1 期
Palatable and chewable tramadol chocolate-based tablets for pain management in paediatric patients
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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