The Effect of Single High Dose of Vitamin D3 on Short-term Postoperative Pain in Patients Under Craniotomy for Brain Tumor Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Short-term postoperative pain: measured by the visual analogue scale or visual analog scale (VAS) that is a pain rating scale
研究概览
简要总结
Vitamin D is a hormone mainly synthesized in the skin in the presence of sunlight. Like other hormones, vitamin D plays a role in a wide range of processes in the body. Some studies have shown vitamin D has anti-inflammatory effects in the body by reducing the release of pro-inflammatory cytokines and suppressing T-cell responses. Therefore, vitamin D may be effective on reduce pain by such mechanisms. In this trial patients with brain tumor under craniotomy will receive a single high dose vitamin D compared to the control group.
详细描述
A randomized, double blind, controlled trial will be conducted in intensive care unit (ICU) and neurosurgery ward, in Shohada-E-Tajrish hospital,Tehran, Iran. First, patients will be carefully checked for inclusion and exclusion criteria. Then, the eligible patients will complete the consent form for this study. 60 eligible brain tumor patients diagnosed by surgeon that are ready for craniotomy will be selected.These patients will be divided into two groups. Intervention group will be received an intramuscular (IM) single dose of vitamin D (300000 IU),while another group will not receive. Pain in patients will be checked daily by up to 3 days after surgery. Finally, the VAS pain score will be compared in both groups.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent of patient or legal representative
- •25(OH)D level below 20ng/dL
排除标准
- •Other trial participation, including previous participation in the pilot trial
- •Pregnant or lactating women
- •Hypercalcemia
- •Hyperphosphatemia
- •Tuberculosis
- •Sarcoidosis
- •History of nephrolithiasis
- •History of hyperparathyroidism
- •Medications that interfere with vitamin D metabolism
- •Renal Insufficiency
研究组 & 干预措施
Vitamin D
Intervention patients will be received a single dose of 300000 IU vitamin D via intramuscular injection
干预措施: vitamin D (Drug)
结局指标
主要结局
Short-term postoperative pain: measured by the visual analogue scale or visual analog scale (VAS) that is a pain rating scale
时间窗: Up to three days after surgery
By questioning from patients for daily pain intensity based on the VAS scale in which pain intensity score by 0 to 10. The "0" and "10" score indicates "no pain" and "worst pain",respectively. also "1-3" , "4-6" and "7-9" score indicates mild, mild to moderate and severe pain, respectively.
次要结局
未报告次要终点
研究者
Zahra Vahdat Shariatpanahi
Associate Professor
Shahid Beheshti University