Dental Pain Study of Analgesics in Patients Undergoing Molar Removal
NCT ID: NCT03652818
Last Updated: 2021-11-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
115 participants
INTERVENTIONAL
2018-06-15
2018-09-20
Brief Summary
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* 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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A
Pre-op Placebo 1;
Post-op Placebo 1;
Post-op Placebo 2
Pre-Op Placebo 1
Placebo 1 will be administered 60 min prior to surgery.
Post-Op Placebo 1
Placebo 1 will be administered post-operatively.
Post-Op Placebo 2
Placebo 2 will be administered post-operatively.
Group B
Pre-op Placebo 1;
Post-op Placebo 2;
Post-op acetaminophen.
Pre-Op Placebo 1
Placebo 1 will be administered 60 min prior to surgery.
Post-Op Placebo 1
Placebo 1 will be administered post-operatively.
Post-Op acetaminophen
Acetaminophen will be administered Post-operatively.
Group C
Pre-op Placebo 1;
Post-op pregabalin;
Post-op Placebo 2.
Pre-Op Placebo 1
Placebo 1 will be administered 60 min prior to surgery.
Post-Op pregabalin
Post-op pregabalin will be administered Post-operatively.
Post-Op Placebo 2
Placebo 2 will be administered post-operatively.
Group D
Pre-op Placebo 1;
Post-op pregabalin
Post-op acetaminophen.
Pre-Op Placebo 1
Placebo 1 will be administered 60 min prior to surgery.
Post-Op pregabalin
Post-op pregabalin will be administered Post-operatively.
Post-Op acetaminophen
Acetaminophen will be administered Post-operatively.
Group E
Pre-op pregabalin;
Post-op Placebo 1;
Post-op acetaminophen.
Pre-Op pregabalin
Pre-op pregabalin will be administered 60 min prior to surgery.
Post-Op Placebo 1
Placebo 1 will be administered post-operatively.
Post-Op acetaminophen
Acetaminophen will be administered Post-operatively.
Interventions
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Pre-Op pregabalin
Pre-op pregabalin will be administered 60 min prior to surgery.
Pre-Op Placebo 1
Placebo 1 will be administered 60 min prior to surgery.
Post-Op pregabalin
Post-op pregabalin will be administered Post-operatively.
Post-Op Placebo 1
Placebo 1 will be administered post-operatively.
Post-Op Placebo 2
Placebo 2 will be administered post-operatively.
Post-Op acetaminophen
Acetaminophen will be administered Post-operatively.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.)
17 Years
55 Years
ALL
Yes
Sponsors
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Nevakar, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kenneth Somberg, MD
Role: STUDY_DIRECTOR
Nevakar, Inc.
Locations
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Jean Brown Research
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CP-NVK009-0001
Identifier Type: -
Identifier Source: org_study_id