Comparison of the Effects of Postoperative Oral Flurbiprofen (0.25%) Spray and Ice Cream on Analgesia and Voice Quality in Patients Undergoing Thyroidectomy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Feasibility of flurbiprofen (0.25%) spray and ice cream on voice quality
研究概览
简要总结
Researchers will compare oral flurbiprofen (%0.25) spray and ice cream to a placebo (a look-alike substance that contains no drug) to see if oral flurbiprofen (%0.25) spray and ice cream works to effect post-thyroidectomy throat pain and voice quality.
Participants will:
- Receive 1 puff of oral flurbiprofen (0.25%) spray or 105 ml of ice cream or 1 puff of oral spray prepared with drinking water (placebo) at 5 hours postoperatively according to randomization result
- Undergo voice analysis using Praat voice analysis (University of Amsterdam) at 6 hours postoperatively
- Undergo a visual analog scale for analgesia status at 6 hours postoperatively
详细描述
Patients undergoing thyroidectomy will be randomized into three groups using a card selection method (this method will be used to ensure that patients' personal medication/food preferences do not affect the randomization). The first group will receive one puff of oral flurbiprofen (0.25%) spray (for pain palliation) at 5 hours post-operatively; the second group will receive 105 ml of frozen ice cream at 5 hours post-operatively; and the third group will receive one puff of spray prepared with drinking water at 5 hours post-operatively as a placebo.
At 6 hours post-operatively, voice analysis will be performed using Praat voice analysis (University of Amsterdam / Netherlands) and analgesia status will be analyzed using a visual analog scale to compare the two methods with each other and with the placebo.
Routine proton pump inhibitor, analgesic, and antiemetic treatments will be administered post-operatively. The patient's clinical follow-up will be documented by the lead investigator and the associate investigator. A case report form will be completed for each registered patient and signed by the lead investigator or co-investigator. This will also apply to records of patients who do not complete the study. If a patient withdraws from the study, the reason will be recorded on the case report form. If a patient withdraws from the study due to a treatment-limiting adverse event, every effort will be made to clearly document the outcome. All forms will be completed legibly with indelible ink. Corrections will be initialed and dated by the lead investigator or co-investigator. The investigator is responsible for the accuracy of the data transferred to the forms and will sign them to demonstrate their consistency with the recorded data.
Patients participating in the study will have their detailed pre-operative allergic status checked and will undergo close vital sign monitoring during the procedure. Volunteer patients may withdraw from the study at any stage at their own request.
This study will be conducted in full compliance with the principles of the "Helsinki Declaration" and the laws and regulations of our country, and will also adhere strictly to the principles outlined in good clinical practice.
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 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No history of neck surgery
- •Age between 18-85 years
- •Undergoing thyroidectomy
- •Agreeing to participate in the study
- •Operation duration between 60-120 minutes
排除标准
- •History of neck surgery
- •History of radiotherapy to the head and neck region
- •Pre-operative or post-operative vocal cord paralysis
- •Pre-operative phonetic disorder
- •Pre-operative laryngeal pathology
- •Being under 18 years of age
- •Refusal to participate in the study
- •Flurbiprofen allergy
- •Lactose intolerance
研究组 & 干预措施
Ice cream group
This group will receive 105 ml of frozen ice cream at 5 hours post-operatively
干预措施: Food Effect cohort (Dietary Supplement)
Placebo group
This group will receive one puff of spray prepared with drinking water at 5 hours post-operatively as a placebo.
干预措施: Placebo Control (Drug)
Oral flurbiprofen (0.25%) spray group
This group will receive one puff of oral flurbiprofen (0.25%) spray (for pain palliation) at 5 hours post-operatively
干预措施: Flurbiprofen (Drug)
结局指标
主要结局
Feasibility of flurbiprofen (0.25%) spray and ice cream on voice quality
时间窗: From enrollment to the postoperative sixth hour.
To compare the effects of flurbiprofen (0.25%) spray and ice cream on voice quality (Praat voice analysis) in patients who underwent thyroidectomy, compared to a placebo group and each other.
Feasibility of flurbiprofen (0.25%) spray and ice cream on pain palliation
时间窗: From enrollment to the postoperative sixth hour.
To compare the effects of flurbiprofen (0.25%) spray and ice cream on pain palliation in patients who underwent thyroidectomy, compared to a placebo group and each other.
次要结局
未报告次要终点
研究者
Serkan Karaisli
Associate Professor, MD, F.E.B.S (End.)
Izmir Katip Celebi University
