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临床试验/NCT05755880
NCT05755880尚未招募不适用

Effect of Addition of Single Low Dose Dexamethasone to Local Anesthetic in Caudal Analgesia on Healing Process After Pediatric and Adolescent Orthopaedic Surgery

Assiut University0 个研究点目标入组 60 人开始时间: 2023年3月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Visual analogue scale

研究概览

简要总结

Addition of dexamethasone to local anesthetics infiltration has been proven to augment postoperative analgesia, prolongs anesthesia time and sometimes reduces the needed dose of local anesthetics and consequently, decreases their side effects and enhances early ambulation and hospital discharge (mainly due to decreased need for opioid use

详细描述

Long-term corticosteroids prescribing was associated with many adverse effects, as increased skin pigmentation, lowering immunity (catching opportunistic infections like herpes zoster, candida and cutaneous abscesses or even flaring localized infections), resistant hyperglycemia, renal impairment, hypertension, impaired healing, thinning skin that bruises easily, adrenal gland suppression, facial erythema, stria, acne, mild hirsutism, blurring vision, muscle weakness, glaucoma, cataract, thinning of hair, osteoporosis, and psychiatric disturbances (including mood fluctuations, depression or manic disorders).

Localized infection at site of injection is a known logical absolute contraindication for any injection including corticosteroids due to fearing of flaring of infection. Also, there is no single published article discussing an infection due to corticosteroids injection as an adjuvant to local anesthetics as it is always explained by inadequate aseptic technique performance.

In this study we will search if there is a role for corticosteroids in delaying healing process after orthopedic surgery. And compare the incidence of postoperative infection after surgery.

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
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 1month up to 18 years old
  • Orthopaedic surgeries with average time up to one hour
  • Traumatic and orthopaedic indications for surgery

排除标准

  • 1- Open fractures
  • Infected surgery
  • Hypersensitivity to dexamethasone
  • Bad nutritional conditions as Marasmus, Cerebral palsy and Kwashiorkor

结局指标

主要结局

Visual analogue scale

时间窗: 30 minutes after recovery

Visual analogue scale (VAS) for assessment of children's pain perception

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bahaaeldin Mohamed Abdelhafez

principal investigator

Assiut University

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