Pain, Acute
Conditions
Keywords
cannabidiol, CBD, acute pain, alternative pain management, simple extraction
Brief summary
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.
Interventions
DRUGcannabidiol
Use of cannabidiol as an alternative to standard of care treatment of acute pain.
DRUGplacebo
Inactive placebo oil to imitate CBD oil
DRUGacetaminophen 500mg and ibuprofen 200mg combo
standard of care
Sponsors
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Worst pain following surgery using Wong Baker Faces pain scale | 1-week post-op | Self-report of participant's worst pain after surgery |
| Amount of medication used | 1-week post-op | Self-report of total amount of pain medication used from participant diary |
| Pain levels following surgery using Wong Baker Faces pain scale | First 72 hours post-op | Self-reported pain recorded every 2 hours between 7am-9pm by automated SMS messaging. |
Countries
United States
Outcome results
None listed