Analgesic Effects Of Dexamethasone; Its Use To Reduce Post Operative Pain Scores: A Double Blinded Randomised Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Post- operative pain scores of the patients using the numerical rating scale, that grades pain from 1-10. The patients will have this scale explained to them. This will be done 24 hours following administration of intraoperative dexamethasone.
研究概览
简要总结
A randomised controlled clinical trial to assess the effect of intraoperative dexamethasone on the 24 hour post operative pain scores of adult patients in Mulago hospital undergoing mastectomies, laparotomies and thyroidectomies. The adverse effects of dexamethasone at this dose were also assessed for.
详细描述
RESEARCH QUESTION TO BE ADDRESSED BY THIS RESEARCH Does intraoperative dexamethasone 12mg reduce 24 hour post-operative pain scores of adult patients undergoing elective laparotomies, thyroidectomies and mastectomies in Mulago hospital RATIONALE FOR THE RESEARCH The treatment of acute post-operative pain is an important health care issue. Inspite of that, its under treatment has been widely recognised over the past two decades. A variety of cultural, attitudinal, religious, educational, political and logistical reasons can be attributed to this and there are a variety of physiological and psychological side effects of this pain.
Dexamethasone is a cheap and readily available drug in Uganda and it has been shown to have analgesic properties.
However, only a few studies have been done to assess these analgesic effects and they have majorly been in tonsillectomies and cardiac surgery. A few such studies have been done on general surgery patients. Most of these studies have been done outside Africa and yet they have demonstrated positive results with regards to optimising analgesia and reducing the post-operative opioid requirements of patients.
This study is yet to be done in Uganda and all the available literature may not necessarily apply to this setting.
GENERAL OBJECTIVE To study the effect of intraoperative dexamethasone 12 mg versus placebo on 24 hour post-operative pain scores of adult patients undergoing elective laparotomies, mastectomies and thyroidectomies in Mulago hospital.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patients scheduled for mastectomies, laparotomies and thyroidectomies that have given informed consent to participate.
- •ASA I & II, patients that have none or have mild to moderate systemic illness.
- •Adult patients, above 18 years old.
排除标准
- •• Patients with Cushing's disease or Cushing's syndrome
- •Patients with diabetes mellitus
- •Systemic infection
- •Previous history of TB infection
研究组 & 干预措施
group1
12 mg( 3 mls) of dexamethasone given 15 mins after induction of anesthesia
干预措施: dexamethasone (Drug)
group2
3 mls of placebo( normal saline) given 15 mins after induction of anesthesia
干预措施: Placebo (Drug)
结局指标
主要结局
Post- operative pain scores of the patients using the numerical rating scale, that grades pain from 1-10. The patients will have this scale explained to them. This will be done 24 hours following administration of intraoperative dexamethasone.
时间窗: 1 year
pain scores assessed using the numerical rating scale, at three points i.e the PACU, 12 and 24 hours post operatively
次要结局
- : Adverse effects of the dexamethasone(1 year)
研究者
College of Health Sciences
Medical doctor
Makerere University