NCT01825655终止4 期
Effect of Long Acting Antihistamine on Opioid- Induced Pruritus: A Double-blind Placebo Controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in Itch Score
研究概览
简要总结
The purpose of this study is determine if long acting antihistamine like cetirizine can help with itching induced by opioid pain medications.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children age 6-18yrs on opioids who develop pruritus and are willing to participate in the study
排除标准
- •Children with history of chronic urticaria
- •Children with other chronic pruritic condition like eczema, contact dermatitis, psoriasis
- •Children with known hypersensitivity to cetirizine/zyrtec
- •Children on H1 antihistamine like diphenhydramine, hydroxyzine, cetirizine, loratadine, fexofenadine, chlorpheniramine within the last 7days prior to randomization
- •Children who have received Ondansetron within 24hrs prior to randomization
- •Children who are on Tricyclic antidepressants
- •Children who are unwilling or unable to swallow the capsule.
- •Children with chronic liver or kidney disease
研究组 & 干预措施
Cetirizine
Active Comparator
zyrtec 10mg, oral, one time
干预措施: Cetirizine (Drug)
Sugar pill
Placebo Comparator
Placebo, one pill, one time
干预措施: Placebo or sugar pill (Drug)
结局指标
主要结局
Change in Itch Score
时间窗: Baseline to 3 hours
Itch score will be used to analyze our primary outcome. The subjects will have an itch score at baseline and compared to itch score at 3hrs post intervention. Itch score is measured on a scale of 1 to 4, with lower scores indicating less itchiness.
次要结局
未报告次要终点
研究者
研究点 (1)
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