A STUDY ON THE ANALGESIC EFFECTS OF DIRECT BREASTFEEDING AND 24 %SUCROSE SOLUTION AGAINST A CONTROL GROUP DURING VACCINATION IN HEALTHY TERM INFANTS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- The primary outcome variable- acute behavioural pain response, will be assessed using a composite score obtained from the modified behavioural pain score for infants.
研究概览
简要总结
This is a randomized control trial of healthy Infants under 1 year of age coming for vaccination to paediatric OPD of MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE Children are randomised into 3 groups using computer generated block randomisation . Analgesic effect of 24%sucrose and breast feeding against a control group is assessed during vaccination. Pain is evaluated using modified behavioural pain scale (MBPS) Along with heart rate, Saturation monitoring as a secondary outcome Each group a sample size of 47 is expected So, total sample size of 141 together in all 3 groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 45.00 Day(s) 至 1.00 Year(s)（—）
- 性别
- All
入选标准
- •Term infants, who are exclusively or partially breastfed and attending the immunization clinic for infantrix Hexa(GSK) vaccination under 1 year of age (6weeks ) .
- •Healthy, developmentally appropriate infants born at 37to 42 weeks’ gestation, with birth weight ≥2.5 kg, All infants should have been fed within three hours prior to the intervention, but shouldn’t have had a feed in the past 30 minutes.
排除标准
- •EXCLUSION CRITERIA: Infants with a current illness -unable to tolerate fluids by mouth.
- •with cerebral palsy where response to painful stimuli may be altered -with perinatal asphyxia with congenital malformations and developmental delay.
结局指标
主要结局
The primary outcome variable- acute behavioural pain response, will be assessed using a composite score obtained from the modified behavioural pain score for infants.
时间窗: 2 years
次要结局
- Duration of cry ,latency of onset(from administration to onset of cry) - Heart rate measurement prior(5min) and post administration at 5 minutes - SpO2 monitoring will also be done at 5 minutes before and after(10min)