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临床试验/NCT02676583
NCT02676583Unknown不适用

Effectiveness of Tonsil Fossa Closure in Pain Relief After Tonsillectomy in Children: Randomized Clinical Trial, Double-blind, Controlled Study

Marco Aurelio Fornazieri1 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
131
试验地点
1
主要终点
Pain

研究概览

简要总结

Objective: Postoperative pain is the main complaint in children undergoing tonsillectomy. An inexpensive method and with few evidence in the literature on effectiveness in reducing pain is the closure of the tonsillar fossa by suture with absorbable sutures. The investigators will compare the pain after tonsillectomy between closure or not the tonsil fossa.

Study design: Prospective, randomized, double blind, and controlled. Method: Two hundred otolaryngologic outpatients with indication of bilateral tonsillectomy for repeated tonsillitis, tonsillar hypertrophy or sleep apnea between 5 and 12 years old will be enrolled from November 2015 to July 2016. The procedure will be performed by a single surgeon and similar postoperative medications will be prescribed. There will be two techniques: closure or not of the tonsillar fossa with catgut points. A questionnaire containing a Faces Pain Scale - filled 1 and 7 days after surgery- and other data - difficulty of detachment of the palatine tonsils, hemostasis technique, surgical complications, healing characteristics, day of total improvement of the pain, day of beginning of normal food intake, presence of postoperative bleeding, complications and observations raised by the patient - will be applied.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • no cognitive-intellectual changes;
  • capacity to respond the questionnaire;
  • able to help in the study

排除标准

  • conducting invasive procedure for less than two months;
  • history of any infection during last month;
  • continuous use of any medication;
  • postoperative fever;
  • non-standard medication prescribed for the postoperative time

结局指标

主要结局

Pain

时间窗: on post-operative procedure (7 days after surgery)

Pain will be assessed using a questionnaire containing a Faces Pain Scale. It will be evaluated the presence of the Pain and the change between the two time points as well.

次要结局

  • Healing characteristics(at 7 days after surgery)
  • Resumption of normal diet(at 7 days after surgery)

研究者

发起方
Marco Aurelio Fornazieri
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marco Aurelio Fornazieri

Responsible MD

Clinica Olfact

研究点 (1)

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