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临床试验/CTRI/2025/08/093546
CTRI/2025/08/093546尚未招募3 期

Comparison of efficacy of Tapentadol nasal spray vs multimodal systemic analgesia for pain control in patient with multiple rib fracture

Sanjay Marwah1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月5日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the pain scores and rescue analgesia requirement in patients receiving Tapentadol nasal spray and multimodal systemic analgesia in patients with multiple rib fractures

研究概览

简要总结

Patients with chest trauma admitted through the emergency department will be managed as per ATLS guidelines, including resuscitation, stabilization, IV analgesics, intercostal nerve block, antibiotics, oxygen support and, if indicated intercostal chest drainage . After stabilization of patient and taking informed consent, they will be randomized by computer-generated numbers into two groups. Group A will receive Tapentadol nasal spray (22.5 mg per nostril, four times daily) along with intercostal nerve block . Group B will receive multimodal systemic analgesia (Tramadol, Paracetamol, Diclofenac in rotation) along with intercostal nerve block  as required. For initial 48 hours, Group A and Group B patients will receive blanket cover of intercostal nerve block (twice a day) and multimodal systemic analgesia /Tapentadol nasal spray. In both the groups, after 48 hours, rescue analgesia with injection diclofenac will be given whenever the pain score is >4. For assessment of pain VAS score is used, a 10-cm line marked on paper, with 0 meaning no pain and 10 denoting maximum pain will be used . Appropriate statistical test of significance will be used to study the differences between both the groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients with chest injury with two or more rib fracture Patients between 18-65 years of age.

排除标准

  • Chest injury without rib fracture or with a single rib fracture Glasgow coma scale less than 15 Patients on ventilator support Patients requiring epidural analgesia Patients leaving against medical advice or in hospital mortality Known allergy to study drug Patients with severe renal or hepatic impairment Patient refusal to participate in the study.

结局指标

主要结局

To compare the pain scores and rescue analgesia requirement in patients receiving Tapentadol nasal spray and multimodal systemic analgesia in patients with multiple rib fractures

时间窗: ENTIRE HOSPITAL STAY AND POST 7 DAY DISCHARGE

次要结局

  • To compare the tolerability and side effects of the drugs used in two groups.(To compare the satisfaction scores of patients receiving two types of analgesia as well as treating surgeons)

研究者

发起方
Sanjay Marwah
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sanjay Marwah

Pandit Bhagwat Dayal Sharma Post Graduate Institute Of Medical Sciences

研究点 (1)

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