Dental Pain Study of Analgesics in Patients Undergoing Molar Removal
| Status: | Completed |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 17 - 55 |
| Updated: | 9/27/2018 |
| Start Date: | June 28, 2018 |
| End Date: | September 11, 2018 |
Randomized, Double-blind, Parallel Group, Single-center, Placebo-controlled Study to Evaluate Efficacy and Safety of Analgesic Combo in Prevention and Treatment of Post-surgical Dental Pain in Healthy Subjects
- 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.
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.
This is a 5 arm randomized, double-blind, parallel group, single-center, placebo-controlled
study to evaluate the efficacy and safety of pregabalin-acetaminophen combination in the
prevention and treatment of post-surgical dental pain in healthy patients.
Subjects in every treatment arm will receive a dose 60 min prior to surgery. It is not
required to receive a post-operative dose if patient does not feel pain at a scale of NRS≥ 5.
Dose 2 will be given post-surgically when patients report at least moderate pain on the
categorical scale and a score of ≥5 on 0-10 PI-NRS. Subsequent to dose 2, patients can
request rescue analgesic at any time.
study to evaluate the efficacy and safety of pregabalin-acetaminophen combination in the
prevention and treatment of post-surgical dental pain in healthy patients.
Subjects in every treatment arm will receive a dose 60 min prior to surgery. It is not
required to receive a post-operative dose if patient does not feel pain at a scale of NRS≥ 5.
Dose 2 will be given post-surgically when patients report at least moderate pain on the
categorical scale and a score of ≥5 on 0-10 PI-NRS. Subsequent to dose 2, patients can
request rescue analgesic at any time.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.)
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