Local Anesthesia and Analgesics in Post-Operative Endodontic Pain
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Effect of long acting anesthesia and analgesics on endodontic pain
研究概览
简要总结
For patients with a toothache, is pain relief after root canal procedure improved using long acting local anesthetic and analgesics? The purpose of this clinical trial is the investigate the effect of long acting local anesthetic with 1 of 4 oral medication groups, on post-operative endodontic pain.
详细描述
Patients (n=220) presenting to the University of Minnesota Endodontic clinic, with moderate to severe pain from toothache requiring root canal treatment ,will be invited to participate in the study. The endodontic treatment is NOT part of the research. Patients will complete pain evaluation forms and take 2 doses of prescribed medication. Normally after a root canal procedure, patients will be suggested to take over-the-counter ibuprofen if needed, or prescribed an analgesic if they are having severe pain. We will be randomizing patients in double blind manner to receive regular or long acting local anesthesia and post-op medications (placebo or 1 of 3 analgesics), with the patient evaluating their pain before starting root canal (pre-treatment pain), after root canal, after analgesics and during the following day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
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
- 是
入选标准
- •18-65 y.o. American Society of Anesthesiologists physical classification I or II Can understand and complete pain evaluation forms tooth pain (>3 out of 10) needing root canal Ability to read and provide informed consent Must be able to swallow tablets
排除标准
- •Allergy/intolerance to analgesics (ibuprofen, naproxen, vicodin) Patients who are pregnant Patients currently on pain medications for an unrelated condition Patients unwilling to fill out pain scales Liver or kidney disease Unable to understand and complete consent form and pain evaluation forms
研究组 & 干预措施
Endododontic Tx + Long acting local anesthetic
long acting local anesthetic
干预措施: Oral placebo (Drug)
Endododontic Tx + Long acting local anesthetic
long acting local anesthetic
干预措施: Oral ibuprofen (Drug)
Endododontic Tx + Long acting local anesthetic
long acting local anesthetic
干预措施: oral naproxen (Drug)
Endododontic Tx + Long acting local anesthetic
long acting local anesthetic
干预措施: oral acetaminophen/hydrocodone + ibuprofen (Drug)
Endodontic Tx plus local anesthetic
local anesthetic
干预措施: Oral placebo (Drug)
Endodontic Tx plus local anesthetic
local anesthetic
干预措施: Oral ibuprofen (Drug)
Endodontic Tx plus local anesthetic
local anesthetic
干预措施: oral naproxen (Drug)
Endodontic Tx plus local anesthetic
local anesthetic
干预措施: oral acetaminophen/hydrocodone + ibuprofen (Drug)
结局指标
主要结局
Effect of long acting anesthesia and analgesics on endodontic pain
时间窗: 36 hours
Pain evaluation time points - pretreatment, after endodontic treatment, 2 hrs after analgesic dosing, following day
次要结局
- Effect of gender and age on post-operative endodontic pain treatment(36 hours)