A Randomized, Double-blinded, Controlled Trial of Adding a Short Burst of Corticosteroid to the Conventional Treatment of H1 Antihistamines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Itch score
研究概览
简要总结
A randomized, double-blinded, controlled trial of adding a short burst of corticosteroid to the conventional treatment of H1 antihistamines
详细描述
Research Methodology
Target Population Patients visit emergency room at King chulalongkorn memorial hospital (KCMH) age between 18-50 years who meet the following criteria of acute urticarial such as
- eruption of wheals, central swelling of various sizes, with or without surrounding erythema; with or without angioedema
- pruritus or occasional burning sensation
- skin returning to normal appearance, usually within 1-24 hours
Exclusion criteria
- patients who have urticarial for more than 48 hours
- have severe underlying disease such as heart disease, kidney disease, liver disease
- pregnancy
- history of Chlorpheniramine, steroid, antihistamines allergy
- history of antihistamine or steroid uses within 48 hours before emergency department visit
- diabetes mellitus
- suspected of more severe disease or severe allergic reaction
- patients who don't have pruritus
- patients who have history of chronic urticaria
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients visit emergency room at King chulalongkorn memorial hospital (KCMH) age between 18-50 years who meet the following criteria of acute urticarial such as
- •eruption of wheals, central swelling of various sizes, with or without surrounding erythema; with or without angioedema
- •pruritus or occasional burning sensation
- •skin returning to normal appearance, usually within 1-24 hours
排除标准
- •patients who have urticarial for more than 48 hours
- •have severe underlying disease such as heart disease, kidney disease, liver disease
- •history of chlorpheniramine maleate, steroid, antihistamines allergy
- •history of antihistamine or steroid uses within 48 hours before ED visit
- •diabetes mellitus
- •suspected of more severe disease or severe allergic reaction
- •patients who don't have pruritus
- •patients who have history of chronic urticaria
研究组 & 干预措施
Experiment 1
Chlorpheniramine 10 mg/amp ; 1 ampule, IV Dexamethasone 5 mg/amp; 1 ampule Cetirizine 10 mg 7 tabs 1 tab OD as home medication
干预措施: IV Dexamethasone (Drug)
Experiment 2
Chlorpheniramine 10 mg/amp ; 1 ampule, IV Dexamethasone 5 mg/amp; 1 ampule Cetirizine 10 mg 7 tabs 1 tab OD as home medication Oral prednisolone 5 mg 20 tabs ; 2*2 po pc as home medication
干预措施: IV Dexamethasone (Drug)
Experiment 2
Chlorpheniramine 10 mg/amp ; 1 ampule, IV Dexamethasone 5 mg/amp; 1 ampule Cetirizine 10 mg 7 tabs 1 tab OD as home medication Oral prednisolone 5 mg 20 tabs ; 2*2 po pc as home medication
干预措施: Oral prednisolone (Drug)
结局指标
主要结局
Itch score
时间窗: 60 mins
letting the patients mark a cross on a straight line. The end of the left side of a line represents "0 = no itch at all", and the end of the right side of a line represents "10 = the worst itch ever possible". The patients aren't allowed to compare the previous VAS score before doing the cross.
次要结局
- Chronic urticaria incidence(1 week, 1 month)
- Itch score(0, 15, 30 mins)