Injection Site Pain, Onset and Duration of Action of Botulinum Toxin Reconstituted in Normal Saline With and Without Sodium Bicarbonate; A Prospective, Single Center, Randomized, Double-Blind Interventional Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Injection site pain
研究概览
简要总结
This study was designed to investigate the effects of botulinum toxin type A injections diluted with the mixture of sodium bicarbonate (SB) and normal saline (NS) on pain reduction, onset of action and duration of action.
This is a prospective, randomized, double-blind clinical study, which included 30 female patients (age>25). The patients were randomized to receive botulinum toxin (BT) injections diluted with NS and SB on one side of the face and saline control injections on the other side. Pain severity was assessed using visual analogue scale. The onset and duration of action were recorded according to the patients' subjective opinions after 1 week and 3 months, respectively. The study was approved with an IRB (Institutional Review Board) number of RC19/371.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Any female patient who is in good health and has moderate dynamic forehead and glabellar wrinkles.
排除标准
- •• Patients <25 years old
- •Presence of neuromuscular disease or intake of drugs affecting muscle tone.
- •Any active infection in the treatment area.
- •Patients receiving anticoagulation or had a diagnosis of bleeding disorders.
- •Any patient who had undergone the following treatments to the forehead area in the past 6 months: botulinum toxin injections, ablative laser procedures, radiofrequency device treatments, ultrasound device treatments, or medium to deep chemical peels.
- •Any patient who had temporary soft-tissue augmentation material to the forehead area in the past 12 months, semi permanent soft-tissue augmentation material in the past 2 years, or permanent soft-tissue augmentation material at any point in the past.
- •Any patient with prior facial cosmetic surgical procedures such as eyebrow-lifts, blepharoplasties, and rhytidectomies.
研究组 & 干预措施
Sodium Bicarbonate
干预措施: Sodium Bicarbonate (Drug)
Normal Saline
干预措施: Normal Saline (Drug)
结局指标
主要结局
Injection site pain
时间窗: Immediately after the injections
Pain severity was assessed using Visual Analogue Scale (VAS).The VAS score ranged from 0 to 10, with 0 representing no pain and 10 the greatest imaginable pain. Higher scores indicated worse outcome.
次要结局
未报告次要终点
研究者
Leen Hijazi
Medical Intern
King Abdulaziz Medical City