A Study of Two Injection Techniques Added to Proven Strategies to Reduce Pain in One- to Twelve-month Old Infants Undergoing Immunization
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Infant Pain as assessed by the Modified Behavioral Pain Scale
研究概览
简要总结
Immunization injections are a significant source of pain for infants. Tactile stimulation (rubbing/applying pressure) may be an effective and feasible pain-relieving intervention - it is cost neutral, and has been shown to be effective in children and adults undergoing injections. The aim of this study is to determine the added benefit of tactile stimulation when added to other proven analgesic interventions during routine infant immunization injections.
详细描述
Immunization injections are a significant source of pain for infants. At present, effective and feasible pain-relieving interventions include sugar water, fast injection without aspiration, and holding infants during the procedure. These methods, however, do not eliminate pain in all infants. Additional interventions are therefore needed.
Tactile stimulation (rubbing/applying pressure) has been shown to reduce injection pain in children and adults, and may be a suitable intervention for infant injections. It is cost neutral, requires no preparation, and is easily incorporated into practice.
The aim of this study is to determine the effectiveness of tactile stimulation when added to other proven analgesic interventions on reducing pain during infant immunization injections.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •infants 1-12 months of age receiving routine immunization injections in an outpatient pediatric clinic in Toronto
排除标准
- •impaired neurological development
- •history of seizure
- •use of topical anesthetics
- •use of sedatives or narcotics within 24 hours
- •fever or illness that would prevent administration of vaccine
- •prior participation in the trial
结局指标
主要结局
Infant Pain as assessed by the Modified Behavioral Pain Scale
时间窗: First 15 seconds after injection
assessed from videotaped procedure
次要结局
- Parent rating of infant pain using the Numerical Rating Scale(first minute after injection)
- Immunizer rating of infant pain using the Numerical Rating Scale(first minute after injection)
- Infant crying time(duration of crying after injection)
研究者
Anna Taddio
Associate Professor, Leslie Dan Faculty of Pharmacy
University of Toronto