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临床试验/CTRI/2026/03/105839
CTRI/2026/03/105839尚未招募1 期

A comparative study on the effect of pre incisional versus postoperative peritonsillar infiltration of 0 point 75 percentage ropivacaine among paediatric patients undergoing coblation tonsillectomy.

Bhagyashree Padickal1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年4月1日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
1 The outcomes to be measured Pain scoring will be done using the FACES pain scale scale at 4 coma 6 coma 24 hours post operative and day 7 of post operative day

研究概览

简要总结

This study aims to compare the effect of pre incisional verses post operative peritonsillar infiltration of 0 point 7 percent ropivacaine on post tonsillectomy pain in pediatric patients undergoing coblation tonsillectomy full stop post operative pain is a major cause of morbidity following tonsillectomy in children and may delay oral intake and recovery full stop Although local infiltration analgesia has been used to reduce pain limited evidence exists regarding the optimal timing of ropivacaine infiltration especially in coblation tonsillectomy full stop

This prospective study will include children aged 3 to 17 years diagnosed with chronic tonsillitis and planned for coblation tonsillectomy full stop Participants will be randomized into two groups full stop Group A will receive preincisonal peritonsillar infiltration of 0 point 75 percent ropivacaine at a dose of 0 point 2 milgram per kilogram full stop Group B will receive post operative infiltration of the same dose full stop Post operative pain will be assessed using Wong Baker FACES pain scale at 4 hours coma 6 hours coma 24 hours and on the seventh post operative day full stop Time to initiation of oral intake and parental satisfaction will also be recorded full stop

The study aims to determine whether the timing of ropivacaine infiltration provides better postoperative pain relief and facilitates early recovery in children undergoing coblation tonsillectomy full stop

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
3.00 Year(s) 至 17.00 Year(s)(—)
性别
All

入选标准

  • Patients with a diagnosis of Chronic tonsilitis fulfilling the Paradise guideline.

排除标准

  • Procedure other than Tonsillectomy Peritonsillar abscess Bleeding disorders Allergy to Ropivacaine.

结局指标

主要结局

1 The outcomes to be measured Pain scoring will be done using the FACES pain scale scale at 4 coma 6 coma 24 hours post operative and day 7 of post operative day

时间窗: 4 coma 6 coma 24 hours post operative and day 7 of post operative day

2 The time at which patients could tolerate

时间窗: 4 coma 6 coma 24 hours post operative and day 7 of post operative day

oral feeds will also be documented

时间窗: 4 coma 6 coma 24 hours post operative and day 7 of post operative day

3 Parental satisfaction regarding the pain outcomes will also be noted

时间窗: 4 coma 6 coma 24 hours post operative and day 7 of post operative day

次要结局

未报告次要终点

研究者

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

Bhagyashree Padickal

Al Azhar Medical Collage and Super Speciality Hospital

研究点 (1)

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