CTRI/2025/05/086328
尚未招募
4 期
Comparative study of post-operative analgesia using Diclofenac sodium suppository vs Acetaminofen suppository in children undergoing Adenotonsillectomy
Dr Mandava Bharath Kumar1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年5月23日最近更新:
概览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Dr Mandava Bharath Kumar
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess the Visual Analogue Scale(VAS) score post operatively
概览
简要总结
It is a prospective, randomized, double blinded comparative study to compare the the post-operative analgesia using diclofenac sodium and acetaminophen suppositories in children undergoing adenotonsillectomy
Parameters that will be compared between the two groups will be the the onset and duration of analgesia and time to rescue analgesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade I or II fit patients.
- •Patients aged between 5 and 12 years of age.
- •Patients undergoing elective adenotonsillectomy pediatric surgery.
- •Written informed consent from the concerned patient guardian.
排除标准
- •Patients who are not willing to participate in the study.
- •Patients with ASA grade III and above physical status.
- •Patients who are posted for emergency procedures.
- •Patients with known allergy to the study drugs.
- •Patients who have psychiatric, coagulopathies, neurological, neuromuscular, or cardiovascular disease or impairment of hepatic or renal function.
- •Patients with inflammatory conditions of rectum and anal canal.
结局指标
主要结局
To assess the Visual Analogue Scale(VAS) score post operatively
时间窗: At 10 and 20 | mins, and then hourly, till patients received rescue analgesic.
次要结局
- To assess the Visual Analogue Scale(VAS) score post operatively in children undergoing adenotonsillectomy(Duration of analgesia will be assessed post)
研究者
Mandava Bharath kumar
Dr. D.Y.Patil Medical College, Hospital and Research Centre
研究点 (1)
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