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临床试验/CTRI/2025/11/097713
CTRI/2025/11/097713尚未招募Phase 3 4

Comparing pain management outcomes: Pre-emptive intravenous Paracetamol versus Ibuprofen in pediatric cleft palate surgeries under General Anaesthesia - a single blinded randomised controlled trial

Tanushree Potluri1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年11月30日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
108
试验地点
1
主要终点
effectiveness of paracetamol and ibuprofen for postoperative pain for cleft palate surgeries

研究概览

简要总结

Postoperative pain management is a critical aspect of patient care in cleft lip and cleft palate surgeries. Cleft palate repair surgery can be associated with significant postoperative pain, discomfort, and distress for the child, highlighting the necessity for adequate pain management strategies. Non-opioid analgesics such as acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and gabapentinoids optimize pain relief while minimizing opioid use. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) known for its analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) properties. Intravenous administration of ibuprofen allows for rapid onset of action, making it useful for managing acute pain in postoperative or perioperative settings. It can be particularly beneficial in multimodal pain management approaches. Healthcare providers use the CHIPPS score, or Children’s International Postoperative Pain Scale, to systematically evaluate and quantify postoperative pain in children, allowing for more effective pain management strategies to be implemented. The CHIPPS score evaluates pain intensity, behavior, and facial expression to provide a comprehensive assessment of pain in children.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
1.00 Year(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 1-5yrs, ASA grade I and II, undergoing cleft palate surgeries under general anaesthesia.

排除标准

  • patients of ASA grades III or IV, hypersensitive to NSAIDs or those with existing cardiac or respiratory disorders.

结局指标

主要结局

effectiveness of paracetamol and ibuprofen for postoperative pain for cleft palate surgeries

时间窗: Pain score immediately assessed after completion of surgery when patient is shifted to the recovery

次要结局

  • efficacy of ibuprofen & paracetamol in reducing post operative opioid consumption in cleft palate surgeries(24 hours after surgery)
  • stable post operative hemodynamics for cleft palate surgeries(24 hours after surgery)

研究者

发起方
Tanushree Potluri
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Tanushree Potluri

Jawaharlal Nehru Medical College, KLE University

研究点 (1)

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