ACTRN12613000984796已完成未知
In patients who have had mandibular wisdom teeth surgically removed, does the addition of codeine 60mg four times daily to paracetamol 1000mg four times daily and ibuprofen 400mg three times daily, compared to paracetamol 1000mg four times daily and ibuprofen 400mg three times daily alone, improve pain relief?
Head of the Department of Oral Diagnostic and Surgical Sciences0 个研究点目标入组 131 人开始时间: 2013年9月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 131
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
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 17 Years 至 o limit(—)
- 性别
- All
入选标准
- •The patient must be aged 17 years or over.
- •There will be no discrimination (e.g. gender; race; ethnicity). Moreover, non-English speaking people will not be excluded; an accredited interpreter will be employed per required need.
- •Patient participation is entirely voluntary.
- •Patients must have been seen by a consultant oral and maxillofacial surgeon at the
- •University of Otago, or by one of their oral and maxillofacial surgery trainees, and be
- •deemed appropriate for participation in the present study by this clinician.
- •The patient must legitimately require at least the removal of one or both of their mandibular third molars.
- •Expected bone removal for extraction of the mandibular third molar(s).
排除标准
- •Patients under 17 years of age are not eligible for participation in this research project. This is to provide a safeguard around the level of drug doses used.
- •The patient must not have any of the following conditions or reasons which contraindicate or caution the use of paracetamol, ibuprofen, or codeine, as described in the latest edition of MIMS New Ethicals:
- •Anyone who needs to drive a motor vehicle or operate machinery within the 48 hour period following surgery
- •NSAID-sensitive asthma
- •Active gastrointestinal bleeding or ulceration
- •Bleeding disorder
- •Patients on anticoagulants P
- •Renal impairment
- •Hepatic impairment
- •Cardiovascular disease
- •Systemic lupus erythematosus
- •Patients on hepatic enzyme inducers (e.g. certain anticonvulsants)
- •Pregnancy and lactation
- •Respiratory depression; COPD
- •Raised intracranial pressure
- •Opioid addiction
- •Patients on CNS depressants
- •G-6-PD deficiency
- •Hypersensitivity to morphine
- •Furthermore, the patient must not have any of the following conditions or reasons which contraindicate or caution the use of midazolam or dexamethasone, as described in the latest edition of MIMS New Ethicals:
- •Hypersensitivity to benzodiazepines
- •Myasthenia gravis
- •Systemic viral, bacterial, or fungal infection
- •Osteoporosis
- •Finally, the patient must not have a contraindication to either intravenous sedation or general anaesthetic.
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