Surgery With Alternative Pain Management (SWAP): Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Pain levels following surgery using Wong Baker Faces pain scale
研究概览
简要总结
The purpose of this study is to evaluate the analgesic effects of cannabidiol for patients who have undergone simple tooth extraction. Participants will be randomized to one of four arms: treatment-as-usual (TAU), cannabidiol 17mg/mL, cannabidiol 37mg/mL, or placebo.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Since TAU participants will receive tablets instead of oil like the other 3 arms, the design is not completely double-blinded; however, the study will be double-blinded between the other three arms which all receive oil in a dropper vial.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting for an operatory appointment at University of Tennessee Health Science Center College of Dentistry Oral and Maxillofacial Surgery Department
- •Operation must be a simple tooth extraction which does not result in an opioid prescription
- •18 years of age or older
- •Have regular and direct access to a device that can send and receive texts and willing to accept any associated charges for 24 text messages
排除标准
- •Contraindication to ibuprofen
- •Contraindication to acetaminophen
- •Contraindication to cannabidiol or hemp oil
- •Contraindication to peppermint oil
- •Contraindication to almond or other tree nuts
- •Currently taking a form of cannabidiol and unwilling to stop use for one week post surgery
研究组 & 干预措施
Treatment As Usual (TAU)
Participants will receive a 5-day supply of acetaminophen 500mg and ibuprofen 200mg.
Instructions for use: Take one tablet of each medication at the same time every 4-6 hours as needed for pain.
干预措施: acetaminophen 500mg and ibuprofen 200mg combo (Drug)
Placebo
Participants will receive a 5-day supply (15mL) of inactive placebo in a dropper vial.
Instructions for use: Place 0.5mL of oil under tongue for 30 seconds then swallow. Use every 4-6 hours as needed for pain.
干预措施: placebo (Drug)
CBD 17mg/mL
Participants will receive a 5-day supply (15mL) of cannabidiol 17mg/mL.
Instructions for use: Place 0.5mL of oil under tongue for 30 seconds then swallow. Use every 4-6 hours as needed for pain.
干预措施: cannabidiol (Drug)
CBD 37 mg/mL
Participants will receive a 5-day supply (15mL) of cannabidiol 37mg/mL.
Instructions for use: Place 0.5mL of oil under tongue for 30 seconds then swallow. Use every 4-6 hours as needed for pain.
干预措施: cannabidiol (Drug)
结局指标
主要结局
Pain levels following surgery using Wong Baker Faces pain scale
时间窗: First 72 hours post-op
Self-reported pain recorded every 2 hours between 7am-9pm by automated SMS messaging.
Amount of medication used
时间窗: 1-week post-op
Self-report of total amount of pain medication used from participant diary
Worst pain following surgery using Wong Baker Faces pain scale
时间窗: 1-week post-op
Self-report of participant's worst pain after surgery
次要结局
未报告次要终点
研究者
Karen Derefinko, PhD
Assistant Professor
University of Tennessee