Comparative Effectiveness of Preemptive Ibuprofen, Ketamine, and Their Combination in Postoperative Pain and Trismus Management Following Third Molar Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups
研究概览
简要总结
The goal of the clinical trial is to compare the efficacy of ibuprofen, ketamine, and their combination in managing postoperative pain and trismus following third molar surgery. The main question it aims to answer is: which is the best way to control pain and trismus after third molar surgery?
详细描述
Materials and methods The study will comprise 100 individuals who requested to have their mandibular third molar tooth extracted at the Erciyes University Faculty of Dentistry. Participants were randomly allocated into four groups, with 25 patients in each group.
The first group (Intrafen group): Each patient in this group will be administered intravenous Ibuprofen (400 mg/8 ml i.v. infusion) for pre-emptive analgesic effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution). The impacted third molars of the patients will be removed.
The second group (Ketamine group): Each patient in this group will be administered intravenous 100 ml saline (Poliflex 0.9% isotonic 100 ml solution) for a placebo effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution) plus 0,3 mg/kg of ketamine (Ketalar 500 mg). The impacted third molars of the patients will be removed.
The third group (Combined group): Each patient in this group will be administered intravenous Ibuprofen (400 mg/8 ml i.v. infusion) for pre-emptive analgesic effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution) plus 0,3 mg/kg of ketamine (Ketalar 500 mg). The impacted third molars of the patients will be removed.
The fourth group (Control group): Each patient in this group will be administered intravenous 100 ml saline (Poliflex 0.9% isotonic 100 ml solution) for a placebo effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution). The impacted third molars of the patients will be removed.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a fully embedded third molar tooth in the mandible
- •Patients with regular attendance for routine follow up
- •Patients with a healthy general systemic condition
排除标准
- •Patients with a fully erupted or partially embedded third molar tooth in the mandible
- •Patients who have previously experienced allergies to NSAIDs, local anesthetics, and ketamine
- •Pregnant or breastfeeding patients
- •Patients who have recently used a different group of NSAIDs for a different condition
结局指标
主要结局
The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups
时间窗: The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups. [The maximum mouth opening of all study participants will be measured and recorded seven days after the surgery].
Trismus was evaluated on the seventh day postoperatively by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at the maximum opening of the jaws.
The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
时间窗: The pain level measurements of all patients will be evaluated by a visual analog scale (VAS) 24 hours following impacted third molar surgery. [All study participants were asked to record their pain levels 24 hours after surgery].
VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)
The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups.
时间窗: The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups. [The maximum mouth opening of all study participants will be measured and recorded before surgery].
Trismus was evaluated preoperatively by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at the maximum opening of the jaws.
次要结局
- The secondary outcome measure is the amount of rescue analgesia used by all participants after impacted third molar tooth surgery.(The mean amount of rescue analgesia used by all participants within the first 24 hours after surgery will be calculated.)
研究者
Cihan Topan
Assistant professor, Principal Investigator, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry
TC Erciyes University