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临床试验/NCT03631433
NCT03631433已完成4 期

An Evaluation of Postoperative Pain Using Ibuprofen Versus Ibuprofen/Acetaminophen in Patients With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis

Ohio State University0 个研究点目标入组 102 人开始时间: 2016年2月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
102
主要终点
Number of Participants

研究概览

简要总结

Aim: The purpose of this study was to compare ibuprofen versus an ibuprofen/acetaminophen combination for postoperative pain control in patients requiring root canal treatment with a tooth that is painful to cold and biting.

Methodology: Following regular root canal treatment, patients randomly received identical appearing tablets of 600 mg ibuprofen or 600 mg ibuprofen/650 mg acetaminophen to be taken every 6 hours as needed for pain. A 4-day diary was used to record pain and medication use.

详细描述

This was a single-center, double-blind, interventional trial where (randomly) one group received ibuprofen and the other group received ibuprofen and acetaminophen.

Before the experiment, the ibuprofen and ibuprofen/acetaminophen groups were assigned 6-digit random numbers. The number assignment determined which drug regimen would be administered postoperatively for each patient. Only the random numbers were recorded on the data collection sheet in order to maintain blinding of the experiment.

The blinding of the ibuprofen and ibuprofen/acetaminophen medications was done as follows. A registered pharmacist compounded identical appearing tablets of 200 mg ibuprofen and tablets of 200 mg ibuprofen/216.7 mg acetaminophen. The tablets were placed in identical-appearing bottles (60 tabs of 200 mg ibuprofen or 60 tabs of a combination of 200 mg ibuprofen/216.7 mg acetaminophen). The pharmacist prepared the master code sheet and assigned the random numbers to the bottles. Therefore, the medication was blind to both the patient and the operator. A copy of the master list of random numbers was supplied by the compounding pharmacist solely to the lead researcher and was not made available to anyone else during the data collection period.

At the end of the debridement appointment, the patient received either a bottle containing 60 tabs of 200 mg ibuprofen or 60 tabs of 200 mg ibuprofen/216.7 mg acetaminophen. The patients were instructed to take 3 tablets every 6 hours as needed for pain.

The patients received a diary for 4 days post-treatment to record pain, percussion pain, and the amount and type of study medications taken. Patients were instructed to tap on the tooth that had emergency endodontic treatment and record this as their percussion pain. Patients recorded their pain levels on a VAS as described earlier for postoperative treatment pain. Starting on the morning after their appointment, patients also recorded the number of study medications taken within each 24-hour period.

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 (Participant, Care Provider, Investigator)

盲法说明

identical appearing tablets and random allocation

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • mandibular (bottom) or maxillary (top) posterior (back) tooth requiring root canal treatment
  • mandibular (bottom) or maxillary (top) posterior (back) tooth with symptomatic irreversible pulpitis and symptomatic apical periodontitis (painful tooth to cold and biting)
  • between the ages of 18 and 65 years of age
  • American Society of Anesthesiologist classification I

排除标准

  • patients younger than 18 or older than 65 years of age
  • American Society of Anesthesiologist classification II or higher
  • allergies or contraindications to ibuprofen
  • allergies or contraindications to acetaminophen
  • inability to give informed consent

研究组 & 干预措施

ibuprofen

Active Comparator

A registered pharmacist compounded identical appearing tablets of 200 mg ibuprofen and tablets of 200 mg ibuprofen/216.7 mg acetaminophen. The tablets were placed in identical-appearing bottles (60 tabs of 200 mg ibuprofen or 60 tabs of a combination of 200 mg ibuprofen/216.7 mg acetaminophen). At the end of the debridement appointment, the patient received either a bottle containing 60 tabs of 200 mg ibuprofen or 60 tabs of 200 mg ibuprofen/216.7 mg acetaminophen. The patients were instructed to take 3 tablets every 6 hours as needed for pain.

干预措施: Ibuprofen 600 mg (Drug)

ibuprofen/acetaminophen combination

Experimental

A registered pharmacist compounded identical appearing tablets of 200 mg ibuprofen and tablets of 200 mg ibuprofen/216.7 mg acetaminophen. The tablets were placed in identical-appearing bottles (60 tabs of 200 mg ibuprofen or 60 tabs of a combination of 200 mg ibuprofen/216.7 mg acetaminophen). At the end of the debridement appointment, the patient received either a bottle containing 60 tabs of 200 mg ibuprofen or 60 tabs of 200 mg ibuprofen/216.7 mg acetaminophen. The patients were instructed to take 3 tablets every 6 hours as needed for pain.

干预措施: ibuprofen 600 mg and acetaminophen 650 mg (Drug)

结局指标

主要结局

Number of Participants

时间窗: 4 day postoperative survey

Number of participants requiring escape pills

Heft Parker Visual Analog Scale Pain Scale Pain Measurements

时间窗: 4 day postoperative survey

Heft-Parker Visual Analog Scale measurements (0-170mm scale) Higher values are a worse outcome.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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