Comparison of Minimal Effective Dose of Sucrose for Pain Relief in Neonates After Minor Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- pain intensity in neonates
研究概览
简要总结
Type of Study: Randomized Controlled Trial Aim: To compare the effectiveness of two doses of sucrose solution for pain relief in neonates after minor procedures.
Participants' Tasks:
Receive either 0.2 ml or 0.5 ml of sucrose solution. Undergo minor procedures. Pain intensity assessment using the Premature Infant Pain Profile (PIPP).
Comparison Groups:
Researchers compared the effects of administering 0.2 ml and 0.5 ml doses of sucrose solution on post-procedural pain in neonates.
详细描述
This study is a randomized controlled trial conducted at the Department of Pediatric Surgery, Holy Family Hospital, Rawalpindi, from March 2023 to February 2024. It aims to compare the effectiveness of two different doses of sucrose solution (0.2 ml versus 0.5 ml) for pain relief in neonates after minor procedures.
Objective:
To compare the outcome of 0.2 ml versus 0.5 ml sucrose solution for pain relief in neonates after minor procedures.
Study Design:
Randomized Controlled Trial
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
- Single (Investigator)
盲法说明
The investigators responsible for assessing the primary outcome measure, pain intensity using the Premature Infant Pain Profile (PIPP), are blinded to the treatment allocation. While neonates and healthcare providers administering the interventions are aware of the treatment groups, the investigators conducting the outcome assessments remain unaware of which dose of sucrose solution each neonate received. This masking of the investigators helps mitigate potential bias in the assessment of pain relief efficacy. However, it is acknowledged that complete masking of all parties involved is not feasible due to the nature of the interventions
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term neonates admitted to the neonatal intensive care unit (NICU) and high dependency unit (HDU) at the Department of Pediatric Surgery, Holy Family Hospital, Rawalpindi.
排除标准
- •Neonates with contraindications for sucrose administration, including:
- •Inability to swallow. Pharmacological muscle relaxation. Heavy sedation. Neonates who are unable to clearly view the infant's face, hindering accurate pain assessment
研究组 & 干预措施
Group I: Neonates receiving a 0.2 ml dose of sucrose solution
Participants in this arm receive a 0.2 ml dose of sucrose solution. Care providers administer the specified dose of sucrose solution to neonates who have undergone minor procedures and are experiencing post-procedural pain. The dose is administered orally, following standardized protocols. Participants in this group are monitored for pain intensity using the Premature Infant Pain Profile (PIPP) by investigators who are masked to the treatment allocation. Data on pain scores and any adverse events are recorded and analyzed as part of the study.
干预措施: 0.2 ml dose of sucrose (Drug)
Group II: Neonates receiving a 0.5 ml dose of sucrose solution.
Participants in this arm receive a 0.5 ml dose of sucrose solution. Similar to Arm 1, care providers administer the specified dose orally to neonates following minor procedures. The administration is conducted according to standardized protocols. Pain intensity in this group is also monitored using the Premature Infant Pain Profile (PIPP) by investigators who remain masked to the treatment allocation. Data collected includes pain scores and any adverse events experienced by participants.
干预措施: 0.2 ml dose of sucrose (Drug)
结局指标
主要结局
pain intensity in neonates
时间窗: immediately after administrating the sucrose
The primary outcome of this study is the measurement of pain intensity in neonates following minor procedures, assessed using the Premature Infant Pain Profile (PIPP). The PIPP is a validated tool used to evaluate pain in preterm and term neonates based on behavioral and physiological indicators.
次要结局
未报告次要终点
研究者
Mehak Fatima
Mehak Fatima
Rawalpindi Medical College