跳至主要内容
临床试验/NCT04202224
NCT04202224已完成不适用

Pre-emptive Analgesia Effect in Different Psycho-emotional Status Patients During Lower Third Molar Surgical Extractions

Lithuanian University of Health Sciences1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2018年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Pre-emptive analgesia is effective in a negative psycho-emotional status patients

研究概览

简要总结

To increase the effectiveness of pain control, it is recommended to use drugs before the pain onset, therefore the pre-emptive analgesia method is considered as a method, which allows decreasing the post-operative pain to minimum. Previous studies evaluated effectiveness of pre-emptive analgesia but no relation to psycho-emotional status was addressed. Our authors believe that the effect of pre-emptive analgesia may vary based on different psycho-emotional status.

45 volunteers who needed extraction of lower third molars were examined and enrolled in the study (study group - 15; placebo - 15; control - 15 volunteers). Ibuprofen 400mg together with 500mg paracetamol was used for pre-emptive analgesia. Difficulty of the operation, heart rate measurements and operation protocol were documented. Surgeon filled his questionnaire after the procedure. Patients on consultation, operation day and 10 days postop. filled a questionnaire which consisted of general, special and pain evaluation sections. Less favorable psycho-emotional status correlated with more severe pain 6h after operation. This relation was mostly expressed in the control group. Psycho-emotional status of placebo patients was accounted for bigger analgesic consumption frequency. Postoperative pain in study group was minimal compared to other groups. Pre-emptive analgesia enhances patient's psycho-emotional status and sustains postoperative pain control during lower third molar surgical extractions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • Adult patients;
  • Indications for mandibular third molar removal.

排除标准

  • Presence of NSAID usage;
  • Acute inflammation in operating site;
  • General diseases that might negatively influence the outcomes of operation, such as epilepsy, unstable neurological condition;
  • Anticoagulant usage;
  • Diabetes mellitus;
  • Cardiovascular diseases.

研究组 & 干预措施

Study

Experimental

Receives pre-emptive analgesia 30min. prior to third molar extraction. NSAID: Ibuprofen 400mg and Acetaminophen 500mg/

干预措施: Ibuprofen 400 mg and Acetaminophen 500 mg (Drug)

Placebo

Placebo Comparator

Receives glucose tablets as pre-emptive analgesia 30min. prior to third molar extraction.

干预措施: Glucose (Drug)

Control

Active Comparator

Receives no medication prior to third molar extraction.

干预措施: No drug (Other)

结局指标

主要结局

Pre-emptive analgesia is effective in a negative psycho-emotional status patients

时间窗: 4 months

Pre-emptive analgesia prior to third molard extraction is effective in different psycho-emotional status patients

次要结局

未报告次要终点

研究者

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

Tomas Puidokas

Practitioner

Lithuanian University of Health Sciences

研究点 (1)

Loading locations...

相似试验

Pre-emptive Analgesia Effect in Different... | 临床试验