The Effect of IM Dexamethasone Administered Pre-operatively Versus Post-operatively on Pain and Edema Following Surgical Extraction of Mesio-angularly Impacted Mandibular 3 rd Molars
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Edema of face in the mandibular region
研究概览
简要总结
TThis is a comparative clinical study which will be conducted in OMFS department of DIKIOHS, DUHS Ojha Karachi. In this study the investigators will be comparing the effect of dexamethasone on pain and edema when administered pre-operatively vs post-operatively following surgery of impacted lower 3rd molars. Time duration of this study will be 2 months. A total of 100 patients will be considered in this study which will be equally divided into two groups; group A and group B (50 in each group).Group A will receive dexamethasone 1 hour pre-operatively while group B will receive the same post-operatively. All surgeries will be performed by the same maxillofacial surgeon and duration of surgery will be around 30-45 mins.
详细描述
To compare the effect of dexamethasone (IM; 8mg) administered pre-operatively versus post-operatively on pain and edema following surgical extraction of mesio-angularly impacted mandibular 3rd molars.
This is a comparative clinical study. This study will be conducted in Oral Maxillofacial Surgery department of DIKIOHS, DUHS Teaching Hospital, Ojha, Karachi, Pakistan. Time duration of this study will be 2 months. A total of 100 patients will be considered in the study (50 in each group). Sample size was calculated through OpenEpi, taking mean values of post-operative 3rd day swelling (cm) of group A (12.15±0.78), group B (13.85±0.78) [Ref #], 95% confidence interval (two sided) and 80% of the power of the test. The sample size came out to be 8 patients (4 in each group). The sampling technique is Convenience Sampling. Patients will be randomly distributed into two groups; Group A & Group B. Group A will receive dexamethasone 8mg Intra-muscularly 1 hour pre-operatively while Group B will receive the same immediately after surgery. All surgeries will be performed by the same maxillofacial surgeon and duration of surgery will be around 30-45 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients coming to dental OPD of DIKIOHS, DUHS, Ojha with Mesioangular impactions
- •Age of patients: 20-50 years
排除标准
- •Patients with known co-morbidities
- •Patients allergic to dexamethasone
- •Patients with history of recent anti-inflammatory drug intake(NSAIDs, steroids, or antihistamines)
- •Pregnant/lactating females
研究组 & 干预措施
Group A
Group A will receive single dose of dexamethasone IM 8mg 1 hour pre-operatively.
干预措施: Dexamethasone injection (Drug)
Group B
Group B will receive a single dose of dexamethasone IM 8mg immediately after surgery.
干预措施: Dexamethasone injection (Drug)
结局指标
主要结局
Change in Edema of face in the mandibular region
时间窗: Change in edema will be assessed from baseline at 1st, 3rd and 7th day post-operatively
edema will be assessed using a measuring tape in three facial planes (M1,M2,M3) M1: Tragus of Ear to Corner of Mouth M2: Tragus of Ear to Pogonion M3: Lateral Canthus of Eye to Angle of Mandible.
次要结局
- Change in Intensity of Pain in the extracted site: Visual Analog Scale (VAS)(Change in the intensity of pain will be assessed from baseline to 1st, 3rd and 7th day post-operatively.)
研究者
Arfa baig
Senior Registrar
Dow University of Health Sciences