Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pain: reduction in severity based on VAS score.
研究概览
简要总结
Pain is an unpleasant sensory experience associated with actual or potential tissue damage. Acute pain management is an important aspect of perioperative anesthetic care. Moreover, it is the most important factor related to patient discomfort after surgery. Adequate pain management, ideally resulting in the complete absence of postoperative pain, not only provides comfort to patients, but may also contribute to improved healing and a reduction in the incidence of postoperative complications. Inadequate postoperative analgesia has been shown to contribute to adverse outcomes, including, but not limited to, immunosuppression, hyperglycemia, poor rehabilitation, and progression to chronic pain.
详细描述
Patients who are scheduled for submucosal resection of nasal septum with or without turbinectomy will be recruited for the study The patients will be will be assigned to either the treatment group who will be administered ketamine prior to the operation or the control group who will receive a normal saline injection, both in identicle syringes.
All patients will be operated on by the same surgoens and by the same method of dissection and hemostasis (2-5 2 ml lidocadrain carpules, monopolar suction-cautery set on 25).
Patients folow-up will be reported in their medical charts. The post operative analgetic effect will be assessed by the amount of analgesia required in the post-operative period and by regular pain measurements using VAS (Visual Analogue Scale) - at 0.5 hours post operation in the recovery room, 8 hours post operation and the morning of first post operative day in the otolaryngology - head and neck department
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing submucosal resection of nasal septum with or without turbinectomy.
- •Over 18 years of age.
- •ASA (anesthsiology Severity Score) score of 1-
- •Signed informed consent by patient or caregiver.
排除标准
- •Allergy to Ketamine
- •Unable/ unwilling to comply with the protocol requirements
- •Pregnancy or breast feeding
- •Chronic use of analgetics
- •History of alcohol and/or drug abuse
- •Previous nasal surgry
研究组 & 干预措施
0.5 mg/kg body weight Ketamin
Patients allocated to this arm will receive an iv dose of 0.5 mg/kg body weight ketamine.
干预措施: Ketamine i.v (Drug)
5 ml normal saline as placebo
Patients allocated to this arm will receive an iv dose of 5ml saline as placebo.
干预措施: Ketamine i.v (Drug)
结局指标
主要结局
Pain: reduction in severity based on VAS score.
时间窗: the morning of first post operative day
The post operative analgetic effect will be assessed by the amount of analgesia required in the post-operative period and by regular pain measurements using VAS (Visual Analogue Scale) - at 0.5 hours post operation in the recovery room, 8 hours post operation and the morning of first post operative day
consumption of postoperative pain medication type, dosage and reduction in the demand postoperatively.
时间窗: the morning of first post operative day
The data will be collected from the medical file
次要结局
- Readmission for any reason.(one week)
- Duration of hospital stay.(one week)
研究者
Ronen Ohad
MD,
Western Galilee Hospital-Nahariya