Effect of the Different Concentrations of Oral Dextrose Solution Applying Together With Supportive Positions on Pain During the Heel-Stick Sampling in Premature Infants: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Pain will be measured by N-PASS
研究概览
简要总结
Within the scope of the newborn screening (metabolic and endocrine diseases) tests (NSTs), this research aims to determine the effect of the different concentrations of oral dextrose solution applying together with supportive positions primarily on the pain scores and secondarily on the duration of crying time during the heel-stick sampling in premature infants.
详细描述
Background Premature infants admitted to the neonatal intensive care unit (NICU) experience pain most frequently due to heel-stick sampling, venipuncture, and peripheral IV placement. The heel-stick method for drawing capillary blood is the most common way to draw newborns' blood. It is used to collect blood for newborn screening tests, usually on the 2nd-7th days after birth. Heel-stick sampling is known to cause moderate to severe pain in premature infants. There is a lack of high-quality evidence in the relevant studies determining effective interventions in the management of pain caused by heel-stick sampling in premature babies.
Research Hypotheses H01: There is no difference in the mean N-PASS scores during the procedure between the groups.
H02: There is no difference in the mean N-PASS scores after the procedure between the groups.
H03: There is no difference in the mean durations of crying after the procedure between the groups.
Design and Settings:This parallel-group randomized trial will be conducted in a Level 4a NICU at a university hospital. For this experimental research, 128 premature infants who will be screened with the routine NSTs are enrolled and randomized into four groups one control group with "supportive positions + oral sterile water (n=32)", one group with "supportive positions + 10% oral dextrose (n=32)", "supportive positions + 20% oral dextrose (n=32)", "supportive positions + 30% oral dextrose (n=32)". The hospital provides education in the field of neonatal nursing (certification) and neonatology (sub-specialty) as a training hospital. The 25-bed unit is one of the tertiary care referral centers in the East Mediterranean Region of Turkey. The admission rate is nearly 214 infants per year on average. Generally, infants come from peripheral (40%), and central (40%) districts, or another city (20%). The unit design is a traditional open-bay type. Heel-stick sampling in premature infants is carried out on the 2nd-10th days after birth within the scope of the NSTs. The Turkish version of the Neonatal Pain Agitation and Sedation Scale (N-PASS) is used as a pain assessment tool in nursing forms. Pain scores of premature infants are evaluated and recorded at each shift change and interventional procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The opaque envelopes are stored in a locked cabinet by the researcher who performed the randomization. The group including the eligible premature infants will not be shared care provider and assessors. Parents will be masked to the groups. Data entries will be performed using the codes A, B, C, and D. Codes will be shared with the researchers after statistical analyses are conducted and the research report is written.
入排标准
- 年龄范围
- 2 Days 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age (GA) at birth 33+0 - 37+0 weeks
- •Admitted to NICU
- •Planned the heel-stick sampling within the scope of the NSTs
- •Parents are able to read, write and speak Turkish
排除标准
- •With a postnatal age of 8 days or more
- •Has contraindications for the administration of oral glucose (genetic, endocrine, metabolic diseases or neurological problems etc.)
- •Has major congenital anomalies
- •Has intubated or receiving a nCPAP
- •Has received analgesics or sedatives for less than 24 hours before the procedure
研究组 & 干预措施
Supportive Positions + Oral Sterile Water
The enrolled premature infants will be administered 1ml of the sterile water a first time 2 minutes before the procedure. After 2 minutes, heel-stick sampling (with an auto lancet for premature infants) will be performed immediately after administering 1 ml of sterile water a second time.
干预措施: Placebo (Other)
Supportive Positions + 10% Oral Dextrose
The enrolled premature infants will be administered 1ml of the 10% oral dextrose solution a first time 2 minutes before the procedure. After 2 minutes, heel-stick sampling (with an auto lancet for premature infants) will be performed immediately after administering 1 ml of 10% oral dextrose solution a second time.
(%10 oral dextrose solution: osmolarity= 550 mOsm/L, pH= 3.5-6.5, calorie=400 kcal/L)
干预措施: 10% Oral Dextrose Solution (Drug)
Supportive Positions + 20% Oral Dextrose
The enrolled premature infants will be administered 1ml of the 20% oral dextrose solution a first time 2 minutes before the procedure. After 2 minutes, heel-stick sampling (with an auto lancet for premature infants) will be performed immediately after administering 1 ml of 20% oral dextrose solution a second time.
(%20 oral dextrose solution: osmolarity= 1010 mOsm/L, pH= 3.2-6.5, calorie= 680 kcal/L)
干预措施: 20% Oral Dextrose Solution (Drug)
Supportive Positions + 30% Oral Dextrose
The enrolled premature infants will be administered 1ml of the 30% oral dextrose solution a first time 2 minutes before the procedure. After 2 minutes, heel-stick sampling (with an auto lancet for premature infants) will be performed immediately after administering 1 ml of 30% oral dextrose solution a second time.
(%30 oral dextrose solution: osmolarity= 1515 mOsm/L, pH= 3.2-6.5, calorie= 1020 kcal/L)
干预措施: 30% Oral Dextrose Solution (Drug)
结局指标
主要结局
Pain will be measured by N-PASS
时间窗: at 2st minute after the heel punction
It is scored with 0 to 2 points available for each criterion (crying/irritability, behavioral state, facial expression, extremity tone and vital signs) and ranged from 0 to 10. Higher values represent higher pain.
次要结局
- Duration of crying will be documented by video recordings(The total crying time is measured from where it starts until the over.)
研究者
Guzide UGUCU
Res. Asst., RN, MScN, PhD Candidate
Mersin University