Comparison Of The Effect Of Dexamethasone Added To Bupivacaine With Plain Bupivacaine For Caudal Block In Patients For Herniotomy.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 96
- 主要终点
- time to first analgesic requirement
研究概览
简要总结
It is a prospective double blind randomized study on the effect of dexamethasone added to bupivacaine with plain bupivacaine for caudal block in patient for herniotomy.
96 patients between the ages 1-6 years will be randomly selected and divided into two groups; B and BD.
Group B will receive 1ml/kg bupivacaine 0.25% (maximum volume 20mls) and group BD will receive a mixture of 0.2mg/kg dexamethasone in 1ml/kg bupivacaine 0.25% (maximum volume = 20mls).
Data taken will then be analyzed and interpreted.
详细描述
METHODOLOGY STUDY DESIGN. The study will be a prospective study. All the patients will be randomized into two groups, B and BD. In group B, patients will receive 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml). In group BD, patients will receive a mixture of 0.2 mg/kg dexamethasone in 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml). The total volume injected will be 1 ml/kg in all patients.
RESEARCH SETTING. The study will take place at Gbagada, Alimosho and Ifako Ijaye General Hospitals in Lagos.
They are all secondary health care facilities with 800 bed spaces in Gbagada, 400 at Alimosho and 300 at Ifako Ijaye. General Hospital Gbagada was established in 1983 and situated in Gbagada, Alimosho in 2006, situated at Igando while Ifako ijaye was created in 2005 and located at Ifako. These three areas are densely populated suburbs of Lagos.
SAMPLE SIZE ESTIMATION. The minimum sample size for this study was calculated with the formula below 21
n= z 2 x p x q d2 Assuming a 95% interval, 5% level of precision and a proportion of 90% 21 .
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 1-6 years, classified as American Society of Anesthesiologist (ASA) 1 and 11 who are undergoing herniotomy and whose parents or legal guardian has duly signed an informed consent form.
排除标准
- •Patients with hypersensitivity to any local anesthetics
- •Children with Bleeding diathesis
- •Presence of Infections at puncture sites
- •Preexisting neurological disease
- •Patients with diabetes mellitus
- •Failure to consent by parents
研究组 & 干预措施
dexametasone (BD),
BD ,a mixture of 0.2mg/kg dexamethasone in 1ml/kg bupivacaine
干预措施: Dexamethasone (Drug)
Bupivacaine,B
B ,1ml/kg bupivacaine:
干预措施: Bupivacaine (Drug)
结局指标
主要结局
time to first analgesic requirement
时间窗: within the first 24 hours post operatively
defined as the time from the caudal injection till the first rescue analgesia was administered (Modified Objective Pain Score, mOPS score of 4 or more).
次要结局
- the number of oral paracetamol(required in the first 24 hours post operatively)
研究者
FAGBOHUN ADUNNI OMOLOLA
Dr
Lagos State University