NCT04057469已完成不适用
Effect of Tulobuterol Patch Versus Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 4
- 主要终点
- perioperative respiratory complication
研究概览
简要总结
- Tonsillectomy is a common pediatric procedure for the treatment of sleep-disordered breathing and chronic tonsillitis. Up to half of children having this procedure experience a perioperative respiratory adverse event.
- We tried to determine whether tulobuterol patch (transdermal bronchodilator) premedication decreases the risk of perioperative respiratory adverse events in children undergoing anesthesia for tonsillectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric patients undergoing tonsillectomy
排除标准
- •recent upper respiratory infection (2weeks)
- •Allergy to tulobuterol patch
- •Patients receiving catecholamine (epinephrine, isoproterenol)
- •hyperthyroidism
- •hypertension
- •cardiac disease
- •Diabetes melitus
- •atopic dermatitis
研究组 & 干预措施
Tulobuterol patch
Experimental
干预措施: Tulobuterol Hydrochloride (Drug)
Placebo
Placebo Comparator
干预措施: Placebo transdermal patch (Drug)
结局指标
主要结局
perioperative respiratory complication
时间窗: from anesthetic induction to postanesthesia care unit discharge, an average of 3 hours
laryngospasm, bronchospasm, oxygen desaturation, airway obstruction, severe coughing, postoperative stridor
次要结局
未报告次要终点
研究者
Hee-Soo Kim
professor
Seoul National University Hospital
研究点 (4)
Loading locations...
相似试验
已完成
1 期
Levobupivacaine vs Levobupivacaine + Dexmedetomidine Infiltration for Post-tonsillectomy Analgesia and Laryngospasm in Pediatric PatientsPost-tonsillectomy AnalgesiaLevobupivacaineNCT04113720Assiut University90
已完成
不适用
Outcome of Laser or Debrider Tonsillotomy Versus Tonsillectomy in Obstructive Sleep ApneaObstructive Sleep ApneaNCT01319058Soroka University Medical Center88
已完成
4 期
A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing TonsillectomyPainTonsillitisNCT01267136Children's Hospitals and Clinics of Minnesota84
Unknown
不适用
Effects of Perioperative TEAS on Postoperative Pain and Agitation in Pediatric Adenoidectomy and Tonsillectomythe Effect of TEAS on the Children' Pain and AgitationNCT05330494Xian Children's Hospital200
撤回
不适用
Tonsillectomy in Adults With Tonsillar Hypertrophy and Obstructive Sleep ApneaObstructive Sleep ApneaNCT02204696University of Southern California