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临床试验/NCT02021240
NCT02021240已完成3 期

Effects of Ketamine in Post-operative Pain and Recovery Outcomes in Bilateral Third Molar Surgery Under General Anaesthesia

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年2月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
150
试验地点
1
主要终点
Pain scores as numerical rating scale after operation

研究概览

简要总结

Low dose sub-anaesthetic dose of ketamine has been shown to reduce postoperative pain and analgesic consumption. However, due to the heterogeneous results, the standard dosing regimen has not been available. Recently, its effect in postoperative outcomes and the development of post-operative surgical pain has also been suggested.

Ketamine has been shown to reduce post-operative early inflammation especially serum IL-6. Therefore, study in its effects in post- operative pain and outcomes due to inflammation is suggested. Only few clinical studies assessed post-operative pain are related to inflammation.

Pain after third molar surgery is a good model of postoperative acute inflammatory pain.

A previous study showed that there was no benefit to administer ketamine before or after oral surgery for pain relief. However, other studies demonstrated that ketamine used as sedative or local ketamine in third molar surgery could reduce postoperative dental pain, swelling and trismus.

Postsurgical facial oedema is difficult to quantify accurately as it is three dimensional. Over the years, various measurement techniques have been tried to measure oedema objectively. These include direct linear measurement using tape or flexible rulers across fixed soft tissue landmarks, standardized stereophotographic measurements, computerized tomography (CT), magnetic resonance imaging (MRI), ultrasonography (US) and three - dimensional (3D) laser scanning. Recently, three dimensional image reconstructions using a reversed engineering technique has been developed and is used in the manufacturing industry. This technology could be applied in a clinical setting for monitoring soft tissue changes.

In this study, the investigators will aim to study the use of sub-anaesthetic dose of ketamine in post-operative dental pain and recovery outcomes.

The investigators hypothesise that post-operative pain after Bilateral Third Molar under General Anaesthesia is less in patients receiving sub-anaesthetic does of ketamine before incision. The magnitude of this effect will be compared with a positive control group (dexamethasone) as well as a placebo group (normal saline). Further, the investigators aim to demonstrate whether ketamine can reduce post-operative facial oedema and other post-operative outcomes.

详细描述

3 groups:

Ketamine group:

• Patient will receive single dose of intravenous ketamine 0.5mg/kg before incision.

Dexamethasone group:

  • Patient will receive single dose of intravenous dexamethasone 8mg before incision Control group
  • Patient will receive single dose of intravenous normal saline before incision.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I and II
  • Bilateral wisdom teeth extraction under general anaesthesia
  • Age over 18
  • Written informed consent

排除标准

  • Allergy to ketamine or dexamethasone
  • Patient refusal
  • Pregnancy
  • Alcohol or drug abuse
  • Known impaired renal function and liver function

研究组 & 干预措施

Ketamine

Active Comparator

Single dose of intravenous ketamine 0.5mg/kg before incision

干预措施: Ketamine (Drug)

Dexamethasone

Active Comparator

Single dose of intravenous dexamethasone 8mg before incision

干预措施: Dexamethasone (Drug)

Normal saline

Placebo Comparator

Single dose of intravenous normal saline before incision

干预措施: Normal Saline (Drug)

结局指标

主要结局

Pain scores as numerical rating scale after operation

时间窗: Every 15 minutes for 1 hour after operation, every 4 hourly at the first 24 hour after operation, and at postoperative 48th and 72rd hour

次要结局

  • Facial oedema measured by using 3D laser scanning of the face(Before operation and at post-operative day1 and day 2)
  • Number of patients having adverse effects(Postoperative day 1 to day 3)
  • Serum IL-6 and TNF - α(Before operation and at postoperative 6th and 16th hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Chi-Wai Cheung

Associate Professor

The University of Hong Kong

研究点 (1)

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