A Randomised Control Clinical Trial Comparing Diclofenac / Acetaminophen /Codeine and Ibuprofen/Acetaminophen/Codeine Combination for Pain Management After Third Molars Surgery
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- post operative pain
研究概览
简要总结
Randomised control clinical trial to compare which combination of analgesics in effective in pain management after third molar extraction of wisdom teeth. The study will assess post operative pain after third molar extraction of two groups of study participants who will be given one of the two combinations of Diclofenac/ acetaminophen/codeine and ibuprofen/acetaminophen/codeine .
详细描述
Double blind randomized control clinical trial to compare the level of pain relief that occurs after third molar extraction done under local anaesthesia at the maxillofacial center, Harare, Zimbabwe. The participants will be randomized into two arms upon fitting the inclusion criteria.The pharmacist will be in charge of randomization and will randomise the participants upon giving them the medications. One group will receive combination of diclofenac/acetaminophen/codeine and the other group will receive ibuprofen/acetaminophen/codeine as post extraction analgesia.The dosages of the medications will be Diclofenac 50mg, ibuprofen 400mg, acetaminophen 500mg and codeine 15mg respectively. Questionnaires will be given to the patient to complete after discharge from the surgery and other parts of the questionnaire will be completed on review after 7 days. A record will be done of the postoperative pain experience (using visual analogue scale), use of rescue medication and details pertaining to impacted tooth.
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 (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
- 是
入选标准
- •patients older than 18 years of age
- •patients undergoing third molar extractions
- •patients with or willing to get orthopantomogram for assessment of impacted third molars
排除标准
- •patients younger than 18 years
- •patients not willing to consent to the study
- •patients with associated co-morbidities
- •patients not willing to undergo radiological evaluation
- •patients allergic to medications used in the study
- •pregnant patients
研究组 & 干预措施
Diclofenac /Acetaminophen/Codeine
routine pain medication used in post extraction pain management
干预措施: diclofenac / acetaminophen /codeine (Drug)
Ibuprofen/Acetaminophen/codeine
routine pain medication used in post extraction pain management
干预措施: ibuprofen/acetaminophen/codeine (Drug)
结局指标
主要结局
post operative pain
时间窗: within 7 days post extraction
record of pain felt by patients on Visual analogue scale using a smiling face to show no pain and worst pain ever with a sad face measured line at 100mm . a score of 100mm indication worst pain and score of 0mm indicating no pain.
次要结局
- Time rescue medication is used(within 7 days post extraction)
- cheek swelling(with in 7 days post extraction)
研究者
Silas Bere
Lecturer
University of Zimbabwe