EFFECT OF FENTANYL NASAL PACK IN REDUCING POST-OPERATIVE PAIN AMONG ADULT POPULATION UNDERGOING SEPTAL AND TURBINATE SURGERIES IN TERTIARY CARE CENTRE IN WAYANAD DURING 2025-2027-A RANDOMISED CONTROL TRIAL
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- This study represents a step forward in the use of fentanyl for managing acute nasal pain, particularly postoperative nasal pain. While many hospitals already employ intravenous fentanyl for postoperative pain control, our findings demonstrate that topical intranasal administration is both localized and effective.
研究概览
简要总结
Fentanyl Citrate is commonly used in injectable form and diluted with saline for nasal application. A standard dose of 25 micrograms is applied to each nasal cavity. The preparation involves mixing 1 milliliter of 50 micrograms per milliliter fentanyl with 4 milliliters of saline to make a concentration of 10 micrograms per milliliter. Gauze or cotton is soaked in this solution and inserted into the nose for 24 hours to provide pain relief and reduce bleeding. Continuous monitoring is essential due to the risk of systemic absorption and respiratory depression.
The experimental group receives nasal packing with fentanyl while the control group gets saline. Pain is measured at 1, 2, 4, 8, and 24 hours using a numeric scale from 0 to 10. Patient satisfaction is rated on the same scale. The same medical staff records all data to ensure consistency. Additional pain relief includes intravenous paracetamol and tramadol, given if needed and recorded.
Risks include respiratory depression, sedation, opioid toxicity, allergic reactions, and nasal irritation. A qualified safety officer monitors for adverse effects. Emergency protocols are in place. Adverse effects are reported to the ethics board within 24 hours.
Stopping rules include two or more cases of respiratory depression or one confirmed overdose. Staff are trained in opioid safety and emergency procedures. Data is collected systematically and kept confidential through secure storage and deidentification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18–65 years 2.Undergoing elective nasal surgery(septoplasty/Turbinate surgeries)requiring nasal packing.
排除标准
- •Allergy or hypersensitivity to opioids, Chronic opioid use or substance abuse
- •Nasal pathology that may alter drug absorption
- •Pregnant or lactating women.
结局指标
主要结局
This study represents a step forward in the use of fentanyl for managing acute nasal pain, particularly postoperative nasal pain. While many hospitals already employ intravenous fentanyl for postoperative pain control, our findings demonstrate that topical intranasal administration is both localized and effective.
时间窗: Assessments were conducted at 1,2,4,8 and 24 hours after surgery.
次要结局
未报告次要终点
研究者
Dr Pallavi T Joy
Dr.Moopens Medical College Hospital