PRL0706: Analgesic Use and Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,773
- 试验地点
- 1
- 主要终点
- Dentist questionnaire
研究概览
简要总结
Opioid analgesics prescribed by dentists may contribute to the larger national issue of the use and abuse of the drug. On occasion dental pain may be sufficiently severe to support the use of opioids. This study used both dentist and patient input to evaluate the use of opioid and over-the-counter analgesics following one of seven coded common dental procedures. The study includes a five day patient follow up assessment of the effectiveness of the analgesic. Baseline questionnaires were completed by eligible participants, and they responded to the day 5 follow up questionnaires.
详细描述
Specific Aims The overall objective of the proposed study is to determine (1) the pattern of analgesic prescriptions (Rx and OTC) and recommendations (OTC) in dental practices; and (2) the effectiveness of and side effects associated with these medications as measured by patientreported outcomes (PROs).
Specific Aim 1: To document (a) dentists' postprocedural prescriptions and recommendations for analgesic medication: and (b) the effectiveness of these medications and side effects associated with their use as measured by PROs.
Specific Aim 2: To analyze by procedure class and anticipated pain severity the PROs of Rx and OTC analgesic medications.
Specific Aim 3: Determine the incidence of analgesic side effects of Rx and OTC analgesic medications.
The outcomes of Specific Aims 1-3 will be:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of erupted second molar teeth.
- •Scheduled for treatment in one procedure of the following six procedure classes:
- •extraction, endodontic therapy, pulp capping, crown preparation, periodontal surgery, abscess treatment
- •Expected by the P-I to experience postoperative pain sufficient to require an analgesic
- •Permanent dentition (erupted 2nd molar teeth)
- •Capacity to judge pain level
- •Ability and willingness to give verbal consent
排除标准
- •Under treatment for medical disorders, including dementia, Parkinson's disease, depression, severe anxiety, or any other medical condition, that, in the opinion of the P-I, would affect the subject's judgment of postoperative pain
- •Current participation in another dental or medical research study.
结局指标
主要结局
Dentist questionnaire
时间窗: baseline
dentists' postprocedural prescriptions were recorded by analgesic class: Opioid, NSAID, or other (Descriptive measures)
次要结局
- Patient questionnaire - OHIP-14 patient reported outcomes quality of life survey (questionnaire).(5 days after the dental procedure)
- Dentist questionnaire - anticipated pain by patients using VAS-5 pain scale(5 days after the dental procedure)