Comparison of antinociceptive effect of order of whole cell DTP and Hepatitis B vaccine in less than 4 months healthy infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- primary outcome was infant pain. Infant pain assessment was done by Modified facial coding System (MFCS) and 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 DTwP vaccine and the Hepatitis-B vaccine is affected by the order in which they are given. Setting: This study is carried out in the immunization clinic, Department of Paediatrics, LLRM Medical College , Meerut, India.Participants-Full term healthy infants, less than four months of postnatal age, who attend immunization clinic for first wDPT vaccine according to universal immunization program. Intervention- infant received either DTwP or Hepatitis B vaccine followed one minute later by other vaccine ..The primary outcome measure was infant pain, which was assessed by Modified facial coding system and Neonatal infant pain scale from the videotapes by a research assistant blinded to the study hypothesis. In addition heart rate , SPO2 was assessed prior to, within 20-30 sec of both vaccine injection . Duration of cry was also assessed as first cry duration ( maximum upto one minute ), second cry duration (maximum upto 3 min after second vaccine injection) and total cry duration ( adding the first and second cry duration)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 4.00 Month(s)（—）
- 性别
- All
入选标准
- •Full term healthy infants, less than four months of postnatal age, who attend immunization clinic for first wDPT vaccine according to universal immunization program.
排除标准
- •â€¢All infants who have required hospital admission more than 48 hrs.
- •â€¢Perinatal asphyxia (1 min Apgar Score <7) or delayed cry if born at home.
- •â€¢Intra-uterine growth retardation (IUGR) i.e. wt < 10th centile for gestational age •Pre-term deliveries.
- •(< 37 week of gestation ) •Previous surgery •Any congenital anomaly •Any chronic medical conditions, •Allergy to any of the vaccine components •Concurrently receiving topical local anaesthetics.
结局指标
主要结局
primary outcome was infant pain. Infant pain assessment was done by Modified facial coding System (MFCS) and Neonatal infant pain scale (NIPS)
时间窗: Pain score (MFCS and NIPS) were assessed prior to first vaccination, immediately after first vaccination, at 20-30 seconds after first vaccination, prior to second vaccination,immediately after second vaccination at 20-30 seconds after 2nd vaccination and at one minute after second vaccination.
次要结局
- secondary outcome was heart rate ,saturation of oxygen(SPO2), and duration of cry(Heart rate and SPO2 was assessed prior to,within 20-30 seconds of administration of both vaccine injection with TruscopeII multi utility Patient monitor(by Schiller).Duration of cry was assessed after first and second vaccine injection as first cry duration( maximum upto one minute after vaccine injection ),second cry duration (maximum upto 3 minutes after vaccine injection) respectively . Additionally total cry duration was calculated by adding first and second cry duration.)