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临床试验/NCT04693208
NCT04693208终止不适用

Analgesic Effect of Laser Therapy in Paediatric Patients Undergoing Tonsillectomy

IRCCS Burlo Garofolo2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
22
试验地点
2
主要终点
Reduction in pain score, age 3-7 years

研究概览

简要总结

Pain management after tonsillectomy could be challenging, with different protocols and various outcome depending on individual patient; moreover, odynophagia due to surgery can, in extreme cases, lead to block oral fluid intake, ending in dehydration and thus hospitalization. A small pilot study demonstrated efficacy of photo-biomodulation (PBM) in managing pain after tonsillectomy and it suggests that PBM can be included in clinical practice. The present research aims to confirm and expand the findings from this study, being the first step in including PBM in clinical routine after tonsillectomy. Use of this treatment, which is non-damaging, non-toxic and easy to supply to patients, could greatly improve individual quality of life after a surgical treatment; its use in the clinical practice could represent an advantage for the institute, leading to more patients' satisfaction, due to the lower pain sensation after surgery and quicker recovery time.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Tonsillectomy or adenotonsillectomy due to apneic chronic snoring and/or obstructive sleep apnea and/or recurrent tonsillitis

排除标准

  • American Society of Anesthesiologists (ASA) Score > 2
  • Neuropsychiatric co-morbidity
  • Pro-hemorrhage coagulation disorders

结局指标

主要结局

Reduction in pain score, age 3-7 years

时间窗: After 24 hours

The score is evaluated using the Wong-Baker scale, ranged 0-10. Higher scores correspond to higher levels of pain.

Reduction in pain score, age 8-18 years

时间窗: After 24 hours

The score is evaluated using a Visual Analogue Scale (VAS) ranged 0-10. Higher scores correspond to higher levels of pain.

次要结局

  • Reduction in pain score, age 3-7 years(After 6 hours)
  • Reduction in pain score evaluated by parents(7 days after discharge)
  • Frequency of use of pain killer drugs(7 days after discharge)
  • Reduction in pain score, age 8-18 years(After 6 hours)
  • Quality of sleep(7 days after discharge)
  • Mean daily food intake.(7 days after discharge)

研究者

发起方
IRCCS Burlo Garofolo
申办方类型
Other
责任方
Sponsor

研究点 (2)

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