ACTRN12618001908224尚未招募4 期
Pre-emptive analgesic and anti-inflammatory effects of etoricoxib and sustained-release ibuprofen following impacted mandibular third molar surgery.
Faculty of Dentistry, University of Otago0 个研究点目标入组 122 人开始时间: 2018年11月23日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 122
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 35 Years（—）
- 性别
- All
入选标准
- •All prospective participants must be seen by the principal investigator with the guidance from a Consultant Oral and Maxillofacial Surgeon (principal supervisor and co-supervisors) at the School of Dentistry, University of Otago.
- •i. Patients must be deemed appropriately suitable for participation in the present study by the principal investigator or a Consultant Oral and Maxillofacial Surgeon (principal supervisor and co-supervisors) at the School of Dentistry, University of Otago.
- •ii. The participant must be aged between 18 and 35 years.
- •iii. The participant must legitimately require removal of at least two mandibular third molars (and may require removal of maxillary third molar/s) as per third molar surgical protocol at the School of Dentistry, University of Otago.
- •iv. Expected bone removal and/or tooth sectioning for extraction of the impacted bilateral mandibular third molars.
- •v. The participant must be medically fit (American Society of Anaesthesiologist (ASA) physical status classification 1 or 2) to have their third molars removed.
- •vi. The participant must be assessed as appropriate for an intravenous (IV) sedation.
- •vii. The participant must consent to having their third molars removed under IV sedation and local anaesthesia.
- •viii. There will be no discrimination based on gender, race, and ethnicity. Non-English-speaking patients will be given equal opportunity to participate; an accredited interpreter will be employed as required.
排除标准
- •i. Patients under the age of 18 years and over 35 years of age
- •ii. Patients are excluded if they meet any of the following criteria:
- •1. Any significant systemic disease/s classified as ASA 3, 4, or 5
- •2. Active/history of gastrointestinal bleeding or ulceration
- •3. Currently pregnant or lactating
- •4. Body weight >120kg
- •5. Cardiovascular disease classified under ASA 3, 4, or 5
- •6. Non-steroidal anti-inflammatory drug (NSAID)-sensitive asthma
- •7. Respiratory depression, chronic obstructive pulmonary disease
- •8. Hepatic impairment
- •9. Renal impairment
- •10. Bleeding disorders
- •11. Therapeutic anticoagulation
- •12. Bone disorders
- •13. Metabolic diseases
- •14. Patients of bisphosphonates
- •15. Patients on long-term benzodiazepines, opioids, and liver enzyme induction agents/medications
- •16. Hypersensitivity to benzodiazepines, etoricoxib, ibuprofen, and codeine phosphate
- •17. Use of NSAIDs within 48 hours prior to the day of surgery
- •18. Presence of swelling, fever, trismus prior to third molar surgery
- •19. Opioid and illicit drug addiction
- •20. Alcoholism
- •21. Current smokers who refuse to stop smoking within 72 hours following third molar surgery
- •22. Patients opting to undergo third molar surgery under local or general anaesthesia
- •23. Patients unable to give informed consent
- •iii. Patients who have third molars with following:
- •1. Associated pathologies
- •2. Third molar/s requiring coronectomy
- •3. Third molars with higher risk of mandibular fracture
- •4. Maxillary third molar/s with higher risk of oro-antral communication
- •5. Oral surgery requiring more than four third molars extracted
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