Effectiveness of Dexketoprofen Trometamol in the Management of Postoperative Endodontic Pain. Controlled Clinical Trial of Multiple Doses
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- post operative pain measurement in symptomatic irreversible pulpitis, after multiple doses of dexketoprofen trometamol
研究概览
简要总结
The purpose of this study is to investigate the analgesic efficacy of multiple doses of Dexketoprofen Trometamol 25 mg on postoperative pain following emergency endodontic treatment in teeth with irreversible pulpitis, using as control Ibuprofen 600 mg and a placebo group.
Hypothesis:
Dexketoprofen trometamol when administered in multiple doses produces a greater effect to control postoperative pain after treating symptomatic irreversible pulpitis; in patients undergoing pulpotomy as an emergency procedure
详细描述
Pain management is an integral part of Endodontics, according to previously published results, pulp therapy and endodontic treatment induce postoperative pain more frequently than other dental procedures.
The prevalence of postoperative pain has been reported in 3-58% of cases, a positive association has been demonstrated between postoperative pain and the presence of apprehension and preoperative pain.
Although the incidence of moderate pain decreases within 1 day and substantially to minimal levels in 7 days after the endodontic treatment, severe postoperative pain occurs during the first 24 h.
Some drugs can prevent the production of inflammatory mediators involved in producing pain, such as prostaglandins.
Prostaglandin tissue levels are associated with patient reports of pain, and therefore, nonsteroidal anti-inflammatory drugs (NSAID's) may be key drugs for inflammatory pain abatement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Subjects aged 18 years and older with moderate-to-severe dental pain assessed by numerical rating scale (NRS) associated with irreversible pulpitis.
排除标准
- •• Female pregnant or breastfeeding
- •Used pain relievers or anti-inflammatory drugs within 24 hours preceding emergency endodontic treatment
- •Have any significant medical condition
- •Taking any medications for anxiety, depression or schizophrenia
- •Have a history of hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs)
研究组 & 干预措施
IBUPROFEN
Administration of 600mg of Ibuprofen, 1 pill right after clinical procedure, the other 3 every 8 until the 24 hours administration period is completed
干预措施: Ibuprofen (Drug)
dexketoprofen trometamol
Administration of 25mg of Dexketoprofen Trometamol, 1 pill right after clinical procedure, the other 3 every 8 until the 24 hours administration period is completed
干预措施: Dexketoprofen trometamol (Drug)
PLACEBO
4 doses of sugar pills, 1 pill right after clinical procedure, the other 3 every 8 until the 24 hours administration period is completed
干预措施: PLACEBO (Drug)
结局指标
主要结局
post operative pain measurement in symptomatic irreversible pulpitis, after multiple doses of dexketoprofen trometamol
时间窗: 1 observation after 72 hours of emergency clinical procedure (Pulpotomy) for pain management
Using a visual analogue scale, each patient is asked to inform the researcher team about postoperative pain levels at 1, 8, 16, 24, 48 and 72 hours after pulpotomy procedure as emergency clinical manage of endodontic pain in irreversible pulpitis cases. Patients will be asked to take multiple doses of either Dexketoprofen Trometamol 25mg, Ibuprofen 600mg or placebo pills. Also, aspects like local anesthetic effect duration and local/systemic side effects will be monitored. Each patient will have a personal file to record the information during each period (1, 8, 16, 24, 48 and 72 hours )
次要结局
- Duration of the activity of the analgesic treatment(observation periods of 1, 8, 16, 24, 48 AND 72 hours)
研究者
Daniel Chavarría Bolaños
Basic Sciences Laboratory, Dentistry School
Universidad Autonoma de San Luis Potosí