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OpenTrials
Completed

NCT Number: NCT04271917

Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients

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.

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Key information

Conditions

Pain, Acute Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cannabidiol

Drug

Use of cannabidiol as an alternative to standard of care treatment of acute pain.

Other names: CBD oil

Placebo

Drug

Inactive placebo oil to imitate CBD oil

acetaminophen 500mg and ibuprofen 200mg combo

Drug

standard of care

Primary outcomes

  1. Worst pain following surgery using Wong Baker Faces pain scale

    Time frame: 1-week post-op

    Self-report of participant's worst pain after surgery

  2. Amount of medication used

    Time frame: 1-week post-op

    Self-report of total amount of pain medication used from participant diary

  3. Pain levels following surgery using Wong Baker Faces pain scale

    Time frame: First 72 hours post-op

    Self-reported pain recorded every 2 hours between 7am-9pm by automated SMS messaging.

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Registry information

Official study title

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

Acronym: SWAP

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2020
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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