Does Preventive Single Dose of Intravenous Dexketoprofen Reduce Pain and Swelling After Orthognathic Surgery? A Prospective, Randomized, Double Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Postoperative 6th hours Pain Score on the Visual Analog Scale
研究概览
简要总结
Background The purpose of this study was to evaluate the effect of a single-dose intravenous dexketoprofen administration for preventive analgesia on postoperative pain and reducing swelling in double jaw surgery.
Material and Methods The authors designed a prospective, randomized, and double-blind cohort study. Patients who have Class III malocclusion were randomly divided in two groups. 50 mg intravenous dexketoprofen trometamol were administrated 30 minutes before incision in treatment group, while intravenous sterile saline was administrated 30 minutes before incision in placebo group. The primary predictor variable was treatment group. Primary outcomes were pain, swelling and 24-hour opioid intake. Patient- controlled analgesia with tramadol was given for management of postoperative pain. Other variables were demographic and operation related parameters. Visual analogue scale was used to evaluate postoperative pain. 3dMD Face System (3dMD, USA) was used to measure postoperative swelling. Data were analysed using two independent samples t test and Mann Whitney U test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for this study were as follows;
- •patients,
- •18-45-year-olds,
- •ASA I status,
- •Class III malocclusion,
- •elective double jaw surgery.
排除标准
- •Exclusion criteria were ASA II and above,
- •drug allergy,
- •liver and kidney failure,
- •pregnant or breastfeeding,
- •long-term use of pain relievers such as NSAIDs and opioids,
研究组 & 干预措施
Drug: Dexketoprofen Tremetamol
50 mg iv dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, Istanbul, Turkey) were administrated 30 minutes before incision in the treatment group (deksketoprofen trometamol n= 15)
干预措施: iv dexketoprofen trometamol (Arveles 50mg/2mL; UFSA, İstanbul, Turkey) (Drug)
Drug: Steril Salin (control)
iv sterile saline were administrated 30 minutes before incision in the placebo group (saline n= 15)
干预措施: Steril Salin (control) (Drug)
结局指标
主要结局
Postoperative 6th hours Pain Score on the Visual Analog Scale
时间窗: postoperative 6th hours.
The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 6th hours."0" represents least pain, "50" represents moderate pain, and 100 represents maximum pain.
Postoperative 1st hours Pain Score on the Visual Analog Scale
时间窗: postoperative 1st hours
The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 1st hours. "0" represents least pain, "50" represents moderate pain, and 100 represents maximum pain.
Postoperative 3rd hours Pain Score on the Visual Analog Scale
时间窗: postoperative 3rd hours.
The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 3rd hours. "0" represents least pain, "50" represents moderate pain, and 100 represents maximum pain.
Postoperative 9th hours Pain Score on the Visual Analog Scale
时间窗: postoperative 9th hours.
The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 9th hours."0" represents least pain, "50" represents moderate pain, and 100 represents maximum pain.
Postoperative 12th hoursPain Score on the Visual Analog Scale
时间窗: postoperative 12th hours.
The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 12th hours. "0" represents least pain, "50" represents moderate pain, and 100 represents maximum pain.
Postoperative 24th hours Pain Score on the Visual Analog Scale
时间窗: postoperative 24th hours.
The postoperative pain was assessed using a 10-cm visual analogue scale (VAS) at postoperative 24th hours. "0" represents least pain, "50" represents moderate pain, and 100 represents maximum pain.
3D measure of postoperative swelling
时间窗: 3D images were taken 90 (T90) day after surgery.
3dMD Face System (3dMD, ATLANTA, GA, USA) was used for 3D imaging of postoperative swelling. The same clinician took the 3D images from patients in natural head position, maximum intercuspation and eyes open. The 3dMD Vultus Software (3dMD, Atlanta, GA) was used to analyse the images. The 3-month postoperative 3D image (t90) was selected as the reference image to compare with other images. After cutting and customizing the images by anatomical structures, scans t0-t30 were matched to the reference scan t90. The forehead, nasion, tragus, medial and lateral canthus were used for surface matching. After surface matching, the volume difference between the masks was calculated
次要结局
未报告次要终点
研究者
Yusuf Nuri Kaba
Principal Investigator
TC Erciyes University