Dental Pain Study of Analgesics in Patients Undergoing Molar Removal

Completed · Phase 2 · Has a placebo group

Conditions studied: Dental Pain

In brief

* Accessing the efficacy and safety of pregabalin when used alone and in combo with acetaminophen in a dental pain model. * To test whether pre-operative dose of pregabalin increases the time to significant post-operative pain (NRS ≥ 5), and hence time to first analgesia consumed post-operatively.

Key facts

Study ID

NCT03652818

Run by

Nevakar, Inc.

People needed

115

Starts

2018-06-15

Expected to finish

2018-09-20

Last updated by the study team

2021-11-23

Who can join

Age: 17 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients who are scheduled to undergo the surgical removal of up to 4 third molars of which at least 2 have to be mandibular molars with a difficulty rating of 4 or 5.
• Patient must have a negative urine drug screen for drugs of abuse (including tobacco) at screening and at the day of surgery.
• No alcohol for a minimum of 1 day prior to the surgery.

You may not qualify if…

• Patients should not be experiencing oral infections or symptoms of concomitant illness at the time of a scheduled surgery.
• Patients with a history of any type of malignancy within the past 5 years other than minor skin related cancers.
• Patients who currently have or have had a history of uncontrolled hypertension.
• Patients with a known allergy or hypersensitivity to any local anesthetic drug, NSAIDs, gabapentin or pregabalin;.
• Patients with conditions that affect the absorption, metabolism, or passage of drugs out of the body (e.g., sprue, celiac disease, crohn's disease, etc.)

Where it is running

• Jean Brown Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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