The Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain After Periodontal Surgery Among Patients at the Henry M. Goldman School of Dental Medicine Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Study enrollment rate of eligible participants
研究概览
简要总结
The main objective of the pilot study is to investigate the process that includes recruitment (to estimate the rate of enrollment), feasibility, protocol refinement, and willingness of the subject to be randomized. To provide a sample estimate of the population parameter which is the true value in the target population to be used in the planning of a larger confirmatory study.
Secondary objectives include:
To examine the efficacy of pre/post-operational administration of dexamethasone vs Vicodin (acetaminophen and hydrocodone) for post-operative pain control following periodontal surgery at the Henry M. Goldman School of Dental Medicine.
To examine how BMI alters the response to dexamethasone and hydrocodone following periodontal surgery since obese patients have shown higher pain scores and increased pain sensitivity in previous experimental models of pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be scheduled for periodontal surgery
- •Subjects must be aged 21 years old and above
- •Able and willing to provide informed consent
- •20 non-obese patients with BMI less than 30kg/m2
- •20 obese patients with BMI greater than or equal to 30kg/m2
- •Diabetic and hypertensive patients included
排除标准
- •Patients allergic to any formulations used in the study
- •Patients with chronic use of nonsteroidal anti-inflammatory drugs or chronic use of narcotics; chronic defined as frequent use or misuse/ abuse so much as once a month
- •Pregnant or lactating female patients; pregnancy test will be performed alongside the medical history
- •Patients with kidney dysfunction
- •Patients at risk for infective endocarditis determined by the medical history or past medical records
研究组 & 干预措施
Dexamethasone
Participants in this arm will take a 6mg dexamethasone tablet the day before surgery, a 6 mg tablet the day of surgery, a 4mg tablet the day after surgery and a 2mg tablet the second day after surgery. Pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.
干预措施: Dexamethasone (Drug)
Vicodin
Participants in this arm will take a vicodin tablet every 4-6 hrs as needed to a maximum of 8 tablets after surgery. Each tablet has 300 mg acetaminophen and 5 mg hydrocodone. Pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.
干预措施: Vicodin (Drug)
结局指标
主要结局
Study enrollment rate of eligible participants
时间窗: 12 months
The proportion of patients that provide consent for the study
次要结局
- Number of participants with breakthrough pain(evening of the surgery, the day after the surgery and one week after the surgery)
- Number medications taken for breakthrough pain(evening of the surgery, the day after the surgery and one week after the surgery)
- Medications taken for breakthrough pain(evening of the surgery, the day after the surgery and one week after the surgery)