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临床试验/NCT02498184
NCT02498184Unknown不适用

Perioperative Acupuncture for Impacted Mandibular Third Molar Extractions - a Double Blinded Randomized Controlled Trial

Ziv Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
pain scale

研究概览

简要总结

This is a double-blinded, randomized, controlled study on the effect of perioperative acupuncture on pain after third molar extraction.

详细描述

Perioperative acupuncture for impacted mandibular third molar extractions - a double blinded randomized controlled trial.

The extraction of impacted third molar teeth is one of the most common surgical procedures performed by oral and maxillofacial surgeons. Post operative pain (POP) remains a significant challenge for all healthcare providers, and is a common complaint after dental and maxillofacial. NSAIDs are commonly used to treat POP and inflammation following a surgical procedure, but they are associated with unwanted side effects and can delay post operative recovery. . Third molar surgeries are associated with significant postoperative morbidity. Many clinicians have emphasized the necessity for better pain control in patients who undergo third molar surgery. Two recent systematic reviews of randomized clinical trials evaluating clinical evidence of the efficacy of acupuncture for postoperative pain control have concluded that perioperative acupuncture may be a useful adjunct for acute postoperative pain. The investigators propose a double-blinded, randomized, controlled study on the effect of perioperative acupuncture on pain in third molar surgery. Methods: 100 patients about to undergo impacted third molar extraction will be recruited. After signing an informed consent, patients will be randomized into two groups: real acupuncture and sham acupuncture. In both groups needles will be placed prior to dental treatment and will be left in place until treatment ends. Prior to treatment, all participants will fill a dental anxiety questionnaire. All patients will receive a detailed explanation regarding the dental procedure. Pre emptive etodolac 400mg will be given prior to starting the procedure. The operation will be performed under local anesthesia. Upon completion of the extraction, local lavage will be performed with physiological saline. If necessary, sutures will be placed using Rapid Vicryl 4/0. Antibiotics will not be given routinely. Patients will be advised to use Etodolac 400mg every 8 hours for the next 3 days, and to perform mouthwashes using commercially available Chlorhexidine digluconate 0.2% starting the following day. Patient follow up and data collection: Pain will be assessed using a VAS (Visual Analog Scale) by an attending nurse blinded to the randomization status, with no knowledge of acupuncture point location. VAS score will be recorded 10 minutes after the start of dental treatment and at treatment's end. Blood pressure and heart rate will be recorded during the procedure every 10 minutes. Post discharge follow up: On the day following discharge patients will be interviewed by telephone and asked to grade their general pain sensation, their ability to perform daily functions and the amount and type of analgesics they used. Inclusion criteria: Otherwise healthy adults above 18y, who are scheduled for an impacted third molar extraction, signed informed consent. Exclusion criteria: no informed consent, coagulopathy, hematological disorder, current corticosteroid therapy, known psychiatric disorder, pregnancy, immunosuppression. Data analysis: Data will be analyzed using standard statistical tests. Study location: Ziv medical center, department of maxillofacial surgery.

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
Triple (Participant, Care Provider, 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
是

入选标准

  • •Otherwise healthy adults above 18y, who are scheduled for an impacted third molar extraction, signed informed consent.

排除标准

  • •no informed consent, coagulopathy, hematological disorder, current corticosteroid therapy, known psychiatric disorder, pregnancy, immunosuppression.

研究组 & 干预措施

real acupuncture

Experimental

traditional chinese acupuncture

干预措施: acupuncture (Other)

sham acupuncture

Sham Comparator

non effective acupuncture

干预措施: acupuncture (Other)

结局指标

主要结局

pain scale

时间窗: 24 hours

次要结局

未报告次要终点

研究者

发起方
Ziv Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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