Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients

Study Overview
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Brief Summary
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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.

Official Title
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Surgery With Alternative Pain Management (SWAP): Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients

Conditions
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Pain, Acute

Intervention / Treatment
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* Drug: cannabidiol
* Drug: placebo
* Drug: acetaminophen 500mg and ibuprofen 200mg combo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment As Usual (TAU)<br>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. | Drug: acetaminophen 500mg and ibuprofen 200mg combo<br>* standard of care<br>|
| Placebo Comparator: Placebo<br>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. | Drug: placebo<br>* Inactive placebo oil to imitate CBD oil<br>|
| Experimental: CBD 17mg/mL<br>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. | Drug: cannabidiol<br>* Use of cannabidiol as an alternative to standard of care treatment of acute pain.<br>* Other names: CBD oil;|
| Experimental: CBD 37 mg/mL<br>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. | Drug: cannabidiol<br>* Use of cannabidiol as an alternative to standard of care treatment of acute pain.<br>* Other names: CBD oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worst pain following surgery using Wong Baker Faces pain scale | Self-report of participant's worst pain after surgery | 1-week post-op | 
| Amount of medication used | Self-report of total amount of pain medication used from participant diary | 1-week post-op | 
| Pain levels following surgery using Wong Baker Faces pain scale | Self-reported pain recorded every 2 hours between 7am-9pm by automated SMS messaging. | First 72 hours post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cannabidiol, CBD, acute pain, alternative pain management, simple extraction