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临床试验/NCT06514222
NCT06514222进行中(未招募)早期 1 期

Pain Control Following Impacted Mandibular Third Molar Surgery: A Comparison of the Effectiveness of Two Different Protocols

University of Sharjah1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
进行中(未招募)
入组人数
56
试验地点
1
主要终点
Visual Analogue Scale

研究概览

简要总结

In this study, the investigators recruited patients undergoing surgical removal of impacted third molar teeth. Participants will be randomly divided into two groups Group 1: The patient will receive 400mg of ibuprofen plus 1000mg of Paracetamol simultaneously every 8 hours for two days.

Group 2- The patient will receive 400mg ibuprofen and 1000mg Paracetamol at 4 hours in intervals for two days. With a total of 3 doses of ibuprofen and 3 doses of paracetamol per day Then, pain control will be assessed using various primary and secondary outcome scales.

详细描述

Surgical removal of an impacted mandibular third molar is one of the most common procedures in oral and maxillofacial surgery. Ten million third molars are extracted from approximately 5 million people in the United States each year. Research suggests that wisdom tooth removal has an immediate negative impact on patients' working and social lives: in one study, patients took an average of 1.6 days off work, with over one-third of patients stating that the surgery had affected their performance at work. Postoperative complications may include swelling, bruising, and limited mouth opening, along with difficulty with eating, which can be a major concern to patients and has not been appreciated by healthcare professionals in the past. However, patients are often most concerned about postoperative pain, which may be severe. Approximately one in two patients will experience pain despite analgesic therapy, even one week after surgery. The inflammatory response to surgical trauma is associated with edema, discomfort, dehiscence, and trismus, and these factors may affect the patient's everyday life. The control of these symptoms is frequently based on pharmacological manipulation of local and systemic pain and inflammation mediators. Combining two analgesic agents with distinct mechanisms or sites of action, such as combining a peripherally acting analgesic with a centrally acting analgesic, has been advocated for many years. A common example is the analgesic formulation containing acetaminophen combined with the opioid hydrocodone or paracetamol with ibuprofen. The pain control of single showed that the maximum effect is recorded in the first 2 to 3 hours. Combining two agents tends to increase the effect for 6 to 8 hours. However, as both medication actions commence simultaneously in the latter combination, they are likely to fade in the same way. This may make the patient likely to overdose on such medicine to ensure the continuity of pain relief. This research aims to test the combination of classical pain medication but in a novel alternate way to minimize the dosage and avoid the risk of side effects and toxicity.

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 (Investigator, Outcomes Assessor)

盲法说明

The evaluators responsible for data collection and analyses are blinded to the analgesic medication regime used by the patients

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years,
  • Need for surgical extraction of at least one fully or partially impacted lower third molar with a degree of difficulty of 5 points or more on the Pedersen scale,
  • ASA I-II status according to the American Society of Anesthesiologists, and
  • No allergy to the drugs under study.

排除标准

  • Breastfeeding
  • ASA III or above
  • Consumption of antibiotics in the week before surgery; and
  • Clinical evidence of acute infection on the day of surgical intervention
  • Radiographic evidence of peri-radicular pathology in impacted teeth requiring extraction

研究组 & 干预措施

study

Experimental

patient will receive 400mg ibuprofen and 1000mg Paracetamol at 4 hours in intervals for two days. With a total of 3 doses of ibuprofen and 3 doses of paracetamol per day

干预措施: Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given together every 8 hours (Drug)

Control

Active Comparator

The patient will receive 400mg of ibuprofen plus 1000mg of Paracetamol simultaneously every 8 hours for two days.

干预措施: Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given alternatively every four hours (Drug)

结局指标

主要结局

Visual Analogue Scale

时间窗: 48 hours

Pain was analyzed in 2 ways: (1) as the mean of pain intensity VAS score evaluated at 0, 4, 8, 12, 24, 36, and 48 hours post-extraction. Range 0-10

The maximum pain experienced by patients

时间窗: 48 hours

a)No pain, b)Some pain, c)Noticeable pain and d)Extreme pain

次要结局

  • Duration of pain control(48 hours)
  • Onset of pain control(48 hours)
  • the rescue medicine intake(48 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kamis Gaballah

Program Director for MDS-Oral Surgery, Associate Professor

University of Sharjah

研究点 (1)

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