Efficacy of 50% Oral Dextrose As Pain Relief in Newborns Before Bladder Catheterization
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- change in blood pressure
研究概览
简要总结
The aim of this study is to determine the effect of 50% oral dextrose in reducing pain before Bladder Catheterization.
This study will answer the following question
Is there any effect of 50% dextrose in reducing pain response to infants from age 1-90 days undergoing bladder catheterization during their visit in emergency department it is double blind randomized control trial comparing 2ml 50% dextrose as oral solution with placebo 2ml of normal water
Primary Objective
- To evaluate the impact of administrating oral glucose on pain control compared with placebo in blood pressure , Heart rate, respiratory rate and oxygen saturation before and after the procedure
Secondary Objectives
- To compare random blood sugar before and after the procedure
- To compare the incident and the duration of crying in both groups
administration of oral solution 2ml of solutions to be administered orally as drops at tip of the tongue after that will wait for 2 minutes before the procedure start , after 2 minutes from the oral solution , the procedure will start
详细描述
During first days of the life of New-borns, they go through a lot of painful procedures such as blood tests and immunizations that lead to painful experiences and distress. For long period of time it was believed that young children do not feel the painful stimuli. Recent studies have proven that they have all the anatomical, physiological and neurochemical system to feel for the pain (1). In fact, they have low threshold for the pain stimuli due to immature suppressive mechanism (2). There are several consequences that pain can cause to children such as: respiratory distress, changes in the metabolic and intracranial system, induce significant behavioural reactions and increase sensitivity to pain.
For these reasons, as well as for ethical reasons, it is advisable to find an acceptable method to reduce pain and distress during painful procedures. Pharmacologic treatment is not recommended for New-borns with acute, recurring, and short-term painful procedures. Studies has reported an alternative way which can be used for pain relive such as using oral sweeteners (3). World-widely, national and international guidelines recommended the use of oral sweeteners such as Sucrose and glucose before painful procedures (4). Researchers found that administration of oral dextrose can raise the pain threshold by activating endogenous opioids (5). The maximum effect can be observed at 2 minutes after administration (6). It is not clear what is the exact effective dose that can be used during painful procedure (7). Several studies used 2ml of dextrose, but other studies have reported an effect with 0.05 mL (8).
Study done by thyr et al (9) shows sweet solution can be used as a simple and safe method to reduce the distress following immunization in infants up to 12 months. A systematic review by Harrison et al (10) reported that Infants aged 1-12 months received oral sucrose or glucose before immunization had moderately reduced incidence and duration of crying.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Randomization will be generated at the local pharmacy by a computer program in blocks of two and the randomization allotment only will be known by a pharmacist not involved in the care of the children.
after that the pharmacist will prepper the syringe than contain the 2ml 50% dextrose or the placebo 2ml normal water. each syringe will have code. the code key will be only with the pharmacist.
入排标准
- 年龄范围
- 1 Day 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 1 day to 90 days
- •Did not received analgesia for last 6 hours
排除标准
- •Preterm newborns presenting in ED younger than 38 weeks (corrected age)
- •Unstable child
- •Suspicion of enterocolitis
- •Esophageal- tracheal fistula not operated
- •Known case of fructose intolerance
- •Oral congenital malformation (cleft palate)
结局指标
主要结局
change in blood pressure
时间窗: 3 minutes, 5 minutes and 7 minutes after oral solution will be administrated
blood pressure will be measured before the procedure and 3 minutes, 5 minutes and 7 minutes after oral solution administration. each vital will be analyzed as single variable comparing it with the baseline. for example (baseline blood pressure will be compared with the blood pressure during procedure after oral solution) the different of both blood pressure will be analyzed whiter there is significant change or not in both group
change in The Neonatal Infant Pain Scale (NIPS)
时间窗: 3 minutes, 5 minutes and 7 minutes after administration of oral solution
the Neonatal Infant Pain Scale (NIPS) will be calculated by trained treating nurse staff 3 minutes, 5 minutes and 7 minutes after administration of oral solution
change in the heart rate
时间窗: 3 minutes, 5 minutes and 7 minutes after oral solution administration.
heart rate will be measured before the procedure and 3 minutes, 5 minutes and 7 minutes after oral solution administration. each vital will be analyzed as single variable comparing it with the baseline. for example (baseline heart rate will be compared with the heart rate during procedure after oral solution) the different of both heart rate will be analyzed whiter there is significant change or not in both group
change in respiratory rate
时间窗: 3 minutes, 5 minutes and 7 minutes after oral solution administration.
respiratory rate will be measured before the procedure and 3 minutes, 5 minutes and 7 minutes after oral solution administration. each vital will be analyzed as single variable comparing it with the baseline. for example (baseline respiratory rate will be compared with the respiratory rate during procedure after oral solution) the different of both heart rate will be analyzed whiter there is significant change or not in both group
次要结局
- random blood sugar(10 minutes)
- the duration of crying in placebo group(10 minutes)
- the duration of crying in dextrose group(10 minutes)
研究者
Ali Redha Taqi Al Qubtan
emergency resident
Oman Medical Speciality Board