Non-pharmacological Analgesia During Heel Prick: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- NIPS score during heel prick in healthy term neonates
研究概览
简要总结
Objective
To investigate the analgesic effect (measured with NIPS) of breastfeeding in addition to skin-to-skin contact versus other methods of non-pharmacological analgesia during blood sampling through heel lance in healthy term neonates. The influences of non-pharmacological methods on crying time, percentage of crying while sampling, heart rate, number of attempts and duration of sampling were studied.
Methods
Randomised controlled trial performed on 136 healthy term newborns in the maternity ward of a tertiary hospital. The inclusion criteria were: healthy term neonates, wish to breastfeed and absence of feeding during the previous 60 minutes. Neonates were randomly assigned to four groups: group 1, breastfed with skin-to-skin contact ; group 2, oral sucrose with skin-to-skin contact ; group 3, skin-to-skin contact ; or group 4, receiving oral sucrose Data for the primary objective was analysed per intention to treat. This study was approved by local ethical committee.
详细描述
Healthy term newborns commonly undergo painful procedures even if they do not need intensive care. Heel lance for neonatal screening is the most frequent standardized painful procedure performed in these newborns. Until recently, analgesics were rarely administered to neonates because it was believed that they were less sensitive to pain than more mature infants but current studies suggest that newborns are able to perceive pain. Regardless of the available evidence, appropriate systematic analgesia in common painful procedures in neonates is far from adequate.
Painful stimuli in neonates may have short-term physiologic (increase in intracranial pressure, increase in heart rate or decrease in oxygen saturation) and behavioural consequences (cry, eye squeeze); as well as long-term consequences (altered of pain response in later infancy). Different non-pharmacological methods of analgesia, such as sucrose, skin-to-skin contact (SSC), breastfeeding(BF) or music10, have been used to reduce pain in neonates undergoing venipuncture or heel lancing, and different physiologic pathways to explain the underlying mechanism have been proposed.
A variety of valid and reliable pain assessment instruments have been developed over the past decades. Yet, behavioural pain assessment remains challenging and controversial due to the lack of a gold standard for neonatal pain expression. The Neonatal Infant Pain Scale (NIPS) and the Premature Infant Pain Profile (PIPP) were selected by an international consensus neonatal pain group for acute procedural pain in neonates.
Our main objective was to investigate the analgesic effect (measured with NIPS) of breastfeeding in addition to SSC versus other methods of non-pharmacological analgesia during blood sampling through heel lance in healthy term neonates. Furthermore, the influences of non-pharmacological methods on crying time, percentage of crying while sampling, heart rate, number of attempts and time of sampling were studied.
METHODS
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
- Single (Care Provider)
入排标准
- 年龄范围
- 37 Weeks 至 41 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term neonates (37-41+6 weeks of gestation) confirmed through a routine physical exam during the first 24h of life
- •Wish to breastfeed
- •Absence of feeding during the previous 60 minutes.
排除标准
- •Maternal use of opioids.
- •Birth in general anesthesia.
- •Artificial feeding.
- •Previous capillar or venous sampling.
- •Previous admission to the neonatal unit.
结局指标
主要结局
NIPS score during heel prick in healthy term neonates
时间窗: Midpoint analysis will be conducted when half the patients are recruited (134 subjects), at an estimated time of 12 months.
The NIPS scale is a validated 6-indicator scale for the assessment of acute pain in neonates. Score ranges from 0 (no pain) to 7 (severe pain). NIPS score was evaluated at three time points (2 minutes before heel prick (NIPS-t0), during heel prick (NIPS-t1) and 2 minutes after heel lance (NIPS-t2))in 4 groups where different methods of non-pharmacological analgesia were applied. Results are shown as mean+-SD. NIPS score ≥4 means moderate-severe pain. Thus results are also shown as the % of patients with NIPS score ≥4 at different time points (t0, t1 and t2)
次要结局
- Crying time during heel prick in healthy term neonates(Midpoint analysis will be conducted when half the patients are recruited (134 subjects), at an estimated time of 12 months.)
- Percentage of crying during heel prick in healthy term neonates(Midpoint analysis will be conducted when half the patients are recruited (134 subjects), at an estimated time of 12 months.)
- Heart rate during heel prick in healthy term neonates(Midpoint analysis will be conducted when half the patients are recruited (134 subjects), at an estimated time of 12 months.)
- Sampling duration during heel prick in healthy term neonates(Midpoint analysis will be conducted when half the patients are recruited (134 subjects), at an estimated time of 12 months.)
- Number of attempts during heel prick(Midpoint analysis will be conducted when half the patients are recruited (134 subjects), at an estimated time of 12 months.)
研究者
Miguel Angel Marin Gabriel
Medical Doctor, Pediatrician, Principal Investigator.
Puerta de Hierro University Hospital