The Effect of Simultaneous Versus Sequential Intramuscular Vaccine Injections on Pain Levels in Infants: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Pain was assessed using the FLACC
研究概览
简要总结
This study was designed as a randomized controlled trial comparing simultaneous and sequential administration of intramuscular vaccines in infants.
详细描述
The study was carried out in the pediatric outpatient vaccination clinic of a private hospital in Istanbul, Türkiye, between 1 September and 15 November 2021.
Infants were eligible if they were younger than 12 months, required two routine intramuscular vaccines during the same visit, and were accompanied by a parent or legal guardian able to provide informed consent.
Infants were excluded if they had received analgesics within six hours prior to vaccination, received vaccines other than hepatitis B, pentavalent combination vaccine (DTaP-IPV/Hib), or pneumococcal conjugate vaccine, or had known neurological, developmental, or motor impairments.
Infants were randomly assigned in a 1:1 ratio to either the simultaneous injection group or the sequential injection group using computer-generated randomization (www.randomizer.org). Allocation was completed prior to the vaccination procedure.
A total of 150 infants were assessed for eligibility; 40 did not meet inclusion criteria. The final sample included 110 infants (55 per group). No participants were lost to follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
All assessments were performed by the same experienced pediatric nurse who was not part of the research team and was unaware of the study hypotheses.
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The following criteria were determined: the child was ordered to receive two of the routine childhood IM vaccines (hepatitis B, quintuple combination vaccine, pneumococcal vaccine), the parents were willing to participate in the study, the child had not received painkillers in the last 6 hours, and the child did not have mental and motor retardation.
排除标准
- •It was determined that the child should be 1 year of age or older, the vaccines other than the quintuple mixed vaccine, Pneumococcal vaccine and Hepatitis B vaccine should have been ordered by the physician.
研究组 & 干预措施
Simultaneous injection group
Two trained pediatric nurses administered the vaccines simultaneously into different thighs (vastus lateralis muscles) following a coordinated countdown.
干预措施: Simultaneous injection (Other)
Sequential injection group
A single nurse administered the two vaccines consecutively into different thighs. A pause of approximately 10-15 seconds between injections allowed the infant to settle.
Vaccinations were performed individually in a quiet room to prevent distraction or distress from other children. Infants were positioned on an examination stretcher with the thigh exposed.
干预措施: Sequential injection (Other)
结局指标
主要结局
Pain was assessed using the FLACC
时间窗: Time Frame: Baseline; During injection (periprocedural); Immediately after injection (within 1 minute)
The scale has 5 behavioral assessment categories (facial expression, leg movement, activity, crying, consolability). Each category consists of three items and is scored between 0 and 2 points. The total scale score ranges from 0 to10, with higher scores indicating greater pain intensity.
次要结局
未报告次要终点
研究者
Sevil Inal
IstanbulUC
Istanbul University - Cerrahpasa