Nebulised Dexmedetomidine Versus Nebulised Fentanyl for the Treatment of Post-Dural Puncture Headache (PDPH) Following Spinal Anaesthesia: A Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the severity of headache after 24 hours of 1st nebulisation
研究概览
简要总结
In this randomized controlled trial 80 patients meeting the inclusion criteria will be enrolled after obtaining written informed consent and randomized into two groups (Group D and Group F), each consisting of 40 patients, using online randomisation software (Open Epi Software Version 3.01). Random allocation will be stored in sequentially numbered opaque sealed envelopes, opened just before the intervention. Group D will receive nebulised Dexmedetomidine 1 mcg/kg (4 ml), and Group F will receive nebulised Fentanyl 1 mcg/kg (4 ml). Nebulisation will be administered every 12 hours for 72 hours post spinal anaesthesia in a semi-recumbent position using a nebuliser. Baseline vitals will be recorded using a monitor. Pain will be assessed using the Numerical Rating Scale (NRS) before and after each nebulisation and at 24 hours after the first session. The requirement of additional analgesics and adverse drug effects will be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to participate
- •Patients of physical status I/II according to American Society of Anaesthesiologists Grading
- •Patients developing PDPH post lower abdominal and lower limb surgeries under spinal anaesthesia within 72 hours
- •Patients qualifying for the criteria of PDPH (with headache severity score more than 4) as laid down by the International Headache Society.
排除标准
- •Patients having history of allergy to the study drug
- •Patients with body mass index less than 25kg/m2
- •Patient with history of migraine or other types of headache, on chronic treatment of headache
- •Patients with hemodynamic instability or bradyarrythmias.
结局指标
主要结局
To compare the severity of headache after 24 hours of 1st nebulisation
时间窗: 24 hours post 1st nebulisation
次要结局
- To assess the incidence rate of PDPH at tertiary care centre, calculate the number of patients requiring additional analgesics, asses any adverse effects (hypotension, bradycardia, oxygen desaturation, dry(mouth, sneezing and coughing) – during and after nebulisation, compare the analgesic effect of nebulised dexmedetomidine to fentanyl using VAS score)
研究者
DR KESHAVI BHARADWAJ
Indira Gandhi Institute of Medical Sciences