Cold Spray for Pain Reduction During Subcutaneous Insulin Injection in the Emergency Department: A Randomized, Placebo-Controlled, Two-Period Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Injection pain on a 100-mm visual analog scale (VAS)
研究概览
简要总结
This randomized, double-blind, placebo-controlled, within-patient crossover trial evaluated whether a vapocoolant (cold) spray applied before subcutaneous insulin injection reduces injection pain compared with a placebo (sterile-water) spray in adults treated in a tertiary-care emergency department. Each participant received a cold spray before one clinically indicated insulin injection and a placebo spray before another, in randomized order, and marked injection pain on a 100-mm visual analog scale 10 seconds after each injection. The within-patient design allowed each participant to serve as their own control.
详细描述
Adults (>=18 years) receiving subcutaneous insulin in the emergency department and expected to require at least one further subcutaneous insulin injection during the same encounter were allocated 1:1 to one of two treatment sequences using block randomization (block size 4). Sequence 1 received the placebo (sterile-water) spray at the first eligible injection and the cold spray at the next; Sequence 2 received the conditions in reverse order. Allocation was concealed with sequentially numbered, opaque, sealed envelopes. The cold-spray and placebo canisters were identical and over-wrapped in identical opaque covering labeled only as canister number one or canister number two, so that both the participant and the administering clinician were blinded to allocation.
All injections were given in the abdomen (at least 5 cm from the umbilicus, alternating sides) using short-acting regular human insulin (100 IU/mL) at room temperature, administered with a 1-mL single-use syringe and a 25-gauge (0.50 x 25 mm) needle. For the active condition the cold spray was applied to the intended injection area for approximately 10 seconds from approximately 30 cm, and the injection was performed approximately 10 seconds later; the needle was kept in the skin for approximately 10 seconds before withdrawal. The placebo spray was delivered in an identical manner. The insulin dose, the interval between the two injections, and the timing of care followed routine clinical practice and were not standardized by the protocol.
The primary outcome was injection pain measured by each participant on a 100-mm paper visual analog scale (0 = no pain, 100 = worst pain imaginable) 10 seconds after each injection, recorded in millimeters. The primary analysis compared the within-patient VAS difference (cold spray minus placebo) across paired observations, with the validity of the crossover design examined using the standard two-by-two decomposition into carry-over, period, and treatment effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Receiving subcutaneous insulin in the emergency department
- •Expected to require at least one further subcutaneous insulin injection during the same encounter
- •Able to complete a 100-mm visual analog scale (VAS)
排除标准
- •Allergy to the spray content
- •Local abnormality at the intended abdominal injection site (e.g., active skin infection, hematoma, extensive scarring, or lipohypertrophy)
- •Cognitive condition precluding reliable VAS assessment (e.g., dementia or Alzheimer disease)
结局指标
主要结局
Injection pain on a 100-mm visual analog scale (VAS)
时间窗: 10 seconds after each injection
Injection pain measured by each participant on a 100-mm paper visual analog scale (0 = no pain, 100 = worst pain imaginable), measured with a ruler and recorded in millimeters. Compared within-patient between the cold-spray and placebo conditions.
次要结局
未报告次要终点
研究者
Faruk Danış, MD
Assistant Professor, Department of Emergency Medicine
Abant Izzet Baysal University