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临床试验/NCT05158348
NCT05158348Unknown3 期

A Comparative Study to Measure the Effect of Nebulized Dexmedetomidine - Lidocaine for Controlling Postoperative Pain After Tonsillectomy in Adults.

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年11月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
60
试验地点
1
主要终点
Postoperative pain 4 hours after tonsillectomy measured by visual analogue score

研究概览

简要总结

A comparative study to measure the effect of nebulized dexmedetomidine - lidocaine for controlling postoperative pain after tonsillectomy in adults.

详细描述

Tonsillectomy is one of the most common procedures in ear, nose, and throat surgery. It is usually performed as a day-stay procedure. [1] Pain is the most common reason for physician contact after discharge, indicating that post-tonsillectomy pain is intense and undertreated. [2] Patients need analgesics that are effective and can be used safely at home.

Adults have a different pattern of pain compared with children; this is related to the different indications and techniques of tonsillectomy. [3, 4] In adults, the surgery is usually performed for chronic infection with scarred tonsils that requires dissection with coagulation, thus causing intense and longer-lasting pain. [5] In children, the indication is usually hypertrophy or recurrent acute infections with smaller changes in tonsil tissues than in adults. [6] Multimodal analgesia has become the standard of care in postoperative pain management. Combinations of analgesics with different sites or modes of action are commonly used to improve analgesia and to reduce the doses of individual analgesics (especially opioids) and to reduce adverse effects.

Systematic reviews on various analgesics for post-tonsillectomy pain have been published for paediatric and adolescent patients.(7,8) Paracetamol (alone and in combination with ibuprofen)NSAIDS,dexamethasone or gabapentenoids(9) Dexmedetomidine is a highly selective adrenergic α-2 agonist that does not cause respiratory depression and can be used as a sedative for various procedures. [10,11] Recently, the use of dexmedetomidine as an additive to local anaesthetics was reported to have several advantages over conventional intravenous administration. [12,13]

Nebulized dexmedetomidine combined with other anaesthetics as a premedication for outpatient paediatric dental procedures has also been reported to provide smoother induction of general anaesthesia with a more rapid recovery and no significant side effects. [14] Nebulized dexmedetomidine-lidocaine inhalation as a premedication for flexible bronchoscopy was well tolerated during bronchoscopies performed under moderate sedation and was associated with a reduced incidence of moderate to severe coughing, a shorter recovery time and reduced vasoconstrictor consumption(15).However, there are no data regarding the use of nebulized dexmedetomidine-lidocaine for controlling postoperative pain after tonsillectomy.

Comparative study II. Study setting and location This study will be conducted at Kasr Al-Ainy tertiary Hospital, Cairo University after being approved by the anesthesia department Research committee and obtaining written informed consent of patients III. Study population 60 patients undergoing tonsillectomy operation will be enrolled in this study divided into 3 groups each of 20 patients. Group A will receive intra-operative local infiltration of saline in tonsillar bed and post-operative nebulised dexametomidine and lidocaine. Group B will receive intra-operative local infiltration of saline and post-operative will receive nebulised lidocaine and group C will receive intra-operative local infiltration of lidocaine and post-operative nebulised saline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of either sex, aged between 18-30 years old, ASA physical status I, II undergoing tonsillectomy.

排除标准

  • Patients were excluded if they had clinically important coronary atherosclerotic heart disease, a history of stroke or transient ischemic attack, Sinus bradycardia or heart block, coagulopathy, peritonsillar abscess, any infection at the site of injection, Known allergy to the study drugs (lidocaine, dexmedetomidine).

研究组 & 干预措施

Group A

Active Comparator

receive intra-operative local infiltration of saline in tonsillar bed and post-operative nebulised dexametomidine and lidocaine.

干预措施: Dexmedetomidine Hydrochloride (Drug)

Group B

Active Comparator

receive intra-operative local infiltration of saline and post-operative will receive nebulised lidocaine

干预措施: Nebulized lidocaine (Drug)

Group C

Active Comparator

receive intra-operative local infiltration of lidocaine and post-operative nebulised saline.

干预措施: Local infiltration of lidocaine (Drug)

结局指标

主要结局

Postoperative pain 4 hours after tonsillectomy measured by visual analogue score

时间窗: 4 hours postoperative

次要结局

  • Postoperative nausea and vomiting following tonsillectomy operation after1 hour , 2 hours and after 4 hours(4 hours postoperative)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dina Mahmoud Mohamed

Principal investigator, lecturer of anesthesia and ICU and pain management

Kasr El Aini Hospital

研究点 (1)

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