A Study to Assess the Role of Two Different Concentrations of Sucrose to Reduce Pain During Initiation of Venipuncture in Extremely Low Birth Weight Babies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Response to pain as assessed by Neonatal Facial Coding Score (NFCS)
研究概览
简要总结
Newborn infants in the neonatal intensive care nursery experience multiple, painful tissue damaging procedures daily.
Preterm especially extremely low birth weights and critically ill newborns admitted to a Neonatal Intensive Care Unit (NICU) undergo repeated skin-breaking procedures that are necessary for their survival. Sucrose is the accepted clinical standard nonpharmacological intervention for managing acute procedural pain for these infants.
However its role in extremely low birth weight infants still need to be addressed. The exact dose and concentration of oral sucrose is still not clear.
When a Medline search was carried out to evaluate the role of two different concentrations (12% vs 24%) of oral sucrose in reducing pain in extremely low birth weight babies, very limited data was available. Cochrane Systemic Review also indicated that specific attention to the efficacy and safety of sucrose administration in extremely low birth weight preterm infants needs to be further investigated. More so, no work on this aspect was identified from the Indian subcontinent. Hence, the current study was planned with an aim to study the effects of 12% and 24% oral sucrose in extremely low birth weight infants during initiation of venipuncture and also study the side effects if any associated with these concentrations. This is a preliminary work on this topic, the results would therefore need to be interpreted with caution. However, the findings and the study design of this work will provide suitable platform for future well powered studies on this population.
详细描述
Research Question
• Is 0.2 ml of 12% oral sucrose not inferior to 0.2 ml of 24% oral sucrose in reducing pain during initiation of venepuncture in extremely low birth weight infants?
Research Hypothesis
• 0.2 ml of 12% oral sucrose is not inferior to 0.2 ml of 24% oral sucrose in reducing pain during initiation of venepuncture in extremely low birth weight infants.
Aims and Objective
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All extremely low birth weight babies (<1000gm) regardless of gestational age being admitted in NICU
- •Within first 48 hrs of post natal life
- •Parental consent
排除标准
- •Neonates requiring ventilatory support
- •Neonates with any neurological impairment (HIE, seizures)
- •Receiving opiates or born to mothers receiving opiates
- •Newborns who have received muscle relaxants, sedatives,analgesics
- •Major congenital anomalies
- •5 mins Apgar of less than 7
- •Neonates undergoing any surgery
- •Birth trauma (especially precipitate deliveries)
- •Instrumental delivery
研究组 & 干预措施
24% Sucrose
The enrolled infants were administered sterile solution of 0.2 ml of 24% sucrose (active control) 2 min prior to procedure.
24% sucrose was prepared by mixing 2.4gm of sucrose in 10ml distilled water.
干预措施: 24% Sucrose (Drug)
12% Sucrose
The enrolled infants were administered 0.2 ml of 12% sucrose 2 min prior to procedure.
These solution were prepared under all sterile precautions by the laboratory staff unrelated to the study. 12%sucrose was prepared by mixing 1.2 gm of sucrose in 10 ml of distilled water. here were two study groups A & B. The enrolled infants were administered sterile solution of 0.2 ml of 24% sucrose (active control) 2 min prior to procedure.
Out of these solutions 1ml was measured by 1 ml syringe and packed and covered with serially numbered opaque sealed envelopes. At the initiation of venepuncture 2 min prior to procedure 0.2 ml of solution marked with patient serial no was administered by a pre-filled syringe to the patient on the anterior aspect of the tongue avoiding spillage, by the personnel carrying out the procedure. The above mentioned personnel was blinded to the contents of the solution.
干预措施: 12% Sucrose (Drug)
结局指标
主要结局
Response to pain as assessed by Neonatal Facial Coding Score (NFCS)
时间窗: The NFCS scale was scored at pre-procedure, intra-procedure (during the initiation of venepuncture). and post 30 sec, 1 min & 2 min of procedure.
In Neonatal Facial Coding System, ten actions were monitored which included brow bulge,eye squeeze,deepening of nasolabial furrow, open lips,vertical mouth stretch, horizontal mouth stretch,cupping of tongue,chin quiver,lip pursing to form O,and tongue protrusion.Each facial action was coded as 1 for occurrence and 0 for no occurrence/absence. The final score was assigned by adding these ten parameters.Thus minimum score could be 0 and the maximum score 10 for a preterm infants
次要结局
- Change in the heart rate from Baseline and the maximum heart rate obtained during the procedure(It was measured pre procedure to 30 sec,1 min and 2 minutes post venepuncture)
- Side effects associated with the administration of sucrose in both the groups.(Any time following 30 minutes of sucrose administration)
研究者
DR. VIKRAM DATTA
Professor
Lady Hardinge Medical College