Efficacy of Postoperative Analgesia Offered by Local Ketamine Wound Instillation Following Total Thyroidctomy; a Randomized, Double-blind, Controlled-clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- total opioid consumption
研究概览
简要总结
This study aims at exploring the analgesic efficacy, and safety of Ketamine instillation into the wound of total thyroidectomy compared to placebo,and to systemic ketamine administration (I.M. injection of the same dose) with respect to postoperative VAS, first request of analgesia, total opioid consumption, and with respect to possible side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with thyroid cancer scheduled for total thyroidectomy.
排除标准
- •Unstable ischaemic cardiac disease
- •Increased intracranial pressure
- •Increased intraocular pressure
- •Hypersensitivity or allergy to ketamine, local anesthetic, morphine, or other drugs used in the study.
- •Severe psychiatric disease
- •Unwillingness or inability to use PCA-device
- •Inability to use VAS scale
研究组 & 干预措施
local ketamine group
intra-wound instillation of ketamine (1 mg/ kg) and normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure, with closure of suction drain tube for 30 min. postoperatively.
干预措施: intra-wound instillation of ketamine (Drug)
control group
intra-wound instillation of normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure, with closure of suction drain tube for 30 min. postoperatively.
干预措施: intra-wound instillation of normal saline (Drug)
systemic ketamine group
Intra-muscular injection of ketamine at a dose of 1 mg/kg before wound closure.
干预措施: systemic administration of ketamine (Drug)
结局指标
主要结局
total opioid consumption
时间窗: 24 hours
the total amount of morphine consumed during follow up period
次要结局
- first request of analgesia(24 hours)
- VAS(24 hours)
研究者
Ahmad Mohammad Abd El-Rahman
lecturer of anesthesia, ICU, and pain management
Assiut University