Pain response in newborns to the order of injecting BCG and Hepatitis-B vaccines
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- The primary outcome measure was the neonatal pain. Pain assessment was done using the neonatal infant pain scale (NIPS).
研究概览
简要总结
This is a Single-center, randomized, parallel group, active controlled trial to determine if acute pain response after administration of the BCG vaccine and the Hepatitis-B vaccine is affected by the order in which they are given. Setting: Vaccination room in the Pediatrics Outpatient Department at KVG Medical College; Karnataka, India. Participants: Healthy term neonates undergoing routine immunization. Interventions: Newborns received either BCG vaccine or the Hepatitis-B vaccine first, followed by the other vaccine. Main Outcome Measures: The primary outcome was neonatal pain during vaccine injection as assessed by a validated measure, the Neonatal Infant Pain Scale (NIPS), scored by resident doctors blinded to the study purpose and hypothesis. In addition, a nurse rated pain using a 10-cm visual analog scale (VAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Randomized study of full term healthy newborns who received the routine dose of BCG and the Hepatitis-B vaccine in the vaccination room of Pediatric Department; KVG Medical College Hospital; Sullia.
排除标准
- •We excluded sick newborns , 5 minute APGAR<7, low birth weight babies, and those who were discharged before the weekly vaccination day.
结局指标
主要结局
The primary outcome measure was the neonatal pain. Pain assessment was done using the neonatal infant pain scale (NIPS).
时间窗: it was measured prior to the vaccine injections and during the vaccine injections.
次要结局
- 10-cm visual analog scale (VAS)(Obtained immediately after the first and second vaccine injections.)