The Effect of Bupivacaine (Marcaine) in Reducing Early Post Tonsillectomy Pain
试验速览
- 阶段
- 4 期
研究概览
简要总结
Research Methodology:
It will be a prospective, randomized, placebo-controlled, single-blind, intra-individual study in which one tonsillar fossa will be the tested side, and the other fossa will be the control. And the tested side will be packed with bupivacaine for five minutes. In the other hand, the controlled side will be packed for five minutes with gauze soaked in normal saline. The selection of the tested side and controlled side will be randomized based on the last digit in the medical record number (i.e. if the last digit is even then the tested side is the right and if the last digit is odd then the tested side is the left). Pain evaluation will be by visual analog scale and it will be in frequency of 2, 4, 6, 8, 12, 24 hours post-op.
详细描述
Evaluation of The Effect of Bupivacaine (marcaine) in Reducing Early Post Tonsillectomy Pain (Prospective, randomized, intra-individual study.) Study guidelines
Aim of the study
- to evaluate the effectiveness of applying bupivacaine intra-operative in reducing early post-tonsillectomy pain
Patients and methods
- It will be a randomized, placebo-controlled, single-blinded study
- one tonsillar fossa will be the tested side, and the other fossa will be the control
- to insure the random selection, the tested and control sides will be selected based on unpredicted method e.g. based on the last number in pt MRN: If the last # is even (0, 2, 4, 6, 8) = right side will be the tested If the last # is odd (1, 3, 5, 7, 9) = left side will be the tested
- Exclusion criteria included :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients undergoing tonsillectomy
排除标准
- •pt with past history of unilateral peritonsillar abscess
- •the current, regular use of a systemic steroid or NSAID
- •a known hypersensitivity to bupivacaine
- •a combined with unilateral myringotomy or bilateral myringotomy with unilateral ventilation tube
- •pt with poor dental hygiene
研究组 & 干预措施
local anesthetic
local anesthetic agent
干预措施: Bupivacaine (Drug)
normal saline
comparator
干预措施: normal saline (Drug)
研究者
Abdulmalik S. Alsaied
otolaryngology specialist
King Saud University