Methodological Validation of Ibuprofen Verses Placebo for Post Operative Pain After Third Molar Extraction Surgery

Lotus Clinical Research

Status and phase

Completed

Phase 4

Conditions

Dental Pain

Treatments

Drug: Placebo

Drug: Ibuprofen

Study type

Interventional

Funder types

Other

Identifiers

NCT02096926

LCR-DEN-01C

Details and patient eligibility

About

This is a single center placebo controlled, prospective, randomized study on healthy adults undergoing third molar surgery.

Enrollment

40 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients who provide written informed consent prior to enrollment
Male or female and 18 to 40 years of age
Patients who are scheduled to undergo elective ipsilateral two (2) third molar extraction surgery under local anesthesia The mandibular third molar must involve full or partial bony impaction confirmed by radiographic evidence
Female subjects are eligible only if all of the following apply
- Not pregnant (subjects of child bearing potential must have a negative urine beta human chorionic gonadotropin (β-hCG) pregnancy test before surgery)
- Not lactating
- Not planning to become pregnant within the duration of the study
Patients who are willing and capable of understanding and cooperating with the requirements of the study
Patients able to understand and communicate in English

Exclusion criteria

Patients who have participated in a Lotus Clinical Research placebo response and pain scale education training program
Patients with a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation, safety, or conduct of the study such as but not limited to a history of severe renal or hepatic impairment, severe active hepatic disease, other acute or chronic pain conditions, or any other clinically significant medical condition
Patients who have a known history of intolerance, severe allergy or hypersensitivity to Ibuprofen, opioid analgesics, Lidocaine, or acetaminophen (APAP)
Patients who have abused any prescription medication or alcohol within two years before the start of the study
Patients who have surgical complications that could compromise safety of the subject or confound the results of the study
The subject is taking any corticosteroid chronically (except for an inhaled steroid for pulmonary disease) or has taken systemic corticosteroids within 4 weeks of the proposed date of surgery
The subject is taking central nervous system (CNS) active drugs such as benzodiazepines, tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) for pain. These drugs are permitted for non-pain indications throughout the study, if the dose has been stable for at least 30 days
The subject has used acetylsalicylic acid, acetaminophen or nonsteroidal antiinflammatory drug (NSAIDs) within 5 half-lives prior to the planned day of the surgery
The subject is taking an antihypertensive agent(s) or a diabetic regimen at a dose that has not been stable for at least 28 days.
Patients who have a history of seizures, or are currently taking anticonvulsants
Patients who have dysphagia and/or cannot swallow study medication whole
Patient who is unable to adequately communicate with study staff, properly give informed consent, or otherwise comply with study procedures
Patient who has participated in another clinical trial of an investigational drug or device within 30 days of screening visit or is schedule to receive an investigational product while participating in the study