40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose But Not Sufficiently Reliefs Acute Pain in Term Neonates: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pain reactivity changes after orally administered 0.5 ml/ kg body 40% dextrose gel or 25% dextrose as procedural pain relief in term neonates requiring a routine heel stick 72 hours after birth.
研究概览
简要总结
The aim of this study was to evaluate the safe of 40% Dextrose oral administration on blood glucose concentration and to reducing of pain before painful procedures on healthy term neonate 72 hours aged.
详细描述
During the study period around 2000 term neonates were born in the university affiliated hospital. Five to 7 term neonates were assessed weekly by the principal investigator (PI) for study eligibility. The parents of neonates who met the inclusion criteria received information about the study after which they were invited to participate. Written informed consent from parent was obtained. The PI entered data into the online Research Randomizer which provided a randomization number corresponding to a numbered treatment pack containing two syringes, each containing 2ml of an identical and therefore blinded liquid. Study investigators, clinical staff, parents and monitors remained blinded to treatment allocation until data analysis was completed. To ensure standardization the included term infants were not breastfeed 30' prior to the heel stick and a standardized heel lance was used.Each infant was taken to a separate room with the mother by the assigned nurse to provide a quite environment. All infants were awake at the time of the procedure. Their clothes were removed and wet diapers were changed. In both groups, the infants were placed in a supine position on a changing table. Dextrose administration and the heel stick were undertaken by an experienced staff neonatal nurse. The heel was warmed with a warm wet towel up 2' minutes before the procedure. The heel was disinfected shortly before the procedure started.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 3 Days 至 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •were born at ≥ 37 weeks of gestation were
- •APGAR score of ≥ 7 five minutes after birth
- •had a postnatal age of ≥ 72 hours
- •were breastfed (but not 30' prior to the testing HS)
- •were undergoing a routine heel stick for metabolic screening between the third and fifth postnatal day
排除标准
- •any kind of medical instabilities needing a transfer to the neonatal intensive care unit (NICU)
- •severe intrapartum asphyxia defined as a 5' Apgar score less than 3
- •parenteral nutrition and the presence of neurological symptoms
- •congenital anomalies
- •other conditions requiring treatment for hypo- or hyperglycemia
- •those in which the heel lance procedure failed
研究组 & 干预措施
Dextrose gel 40%
before heel lance, 2 ml oral dextrose gel 40% was administered, and pain related intensity was evaluated with premature infant pain profile scale
干预措施: Dextrose (Drug)
Dextrose gel 25%
before heel lance, 2ml oral dextrose gel 25% was administered, and pain related intensity was evaluated with premature infant pain profile scale
干预措施: Dextrose (Drug)
结局指标
主要结局
Pain reactivity changes after orally administered 0.5 ml/ kg body 40% dextrose gel or 25% dextrose as procedural pain relief in term neonates requiring a routine heel stick 72 hours after birth.
时间窗: one routine heel stick 72 hours after birth
Pain reactivity changes were assessed using the Premature Infant Pain Profile-revised (PIPP-R scale) which is composed of three behavioral, two physiological and two contextual pain indicators. Five measurements were undertaken during one routine heel stick which took place 72 hours after birth, on the bed side and coded through direct observation during 15 seconds at 5 different time points: 1. t0: before the heel lance (= baseline 30 minutes without stimuli before heel stick); 2. t1: at the end of the heel lance (after the ending of the squeezing of the heel and successful collection of blood drops); 3. t2: at 1 minute recovery time; 4. t3: at 2 minutes recovery time; 5. t4: at 5' minutes recovery time.
次要结局
- Blood glucose levels changes after orally administered 0.5 ml/kg body 40% dextrose gel or 25% dextrose as procedural pain relief in term neonates requiring a routine heel stick 72 hours after birth.(one routine heel stick 72 hours after birth and at 30 minutes after orally 0.5 ml/kg body 40% dextrose gel or 25% dextrose)