Efficacy Study of IV Ibuprofen vs IV Acetaminophen Post Surgical Extraction

• Status: Unknown status
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare how effective a single dose of an intravenous (IV) ibuprofen is when compared to single dose of IV acetaminophen in reducing pain. We will administer this study medication thirty minutes prior to removal of wisdom teeth. We want to see if administering these drugs prior to surgery may reduce post-operative pain.

Administration of nonsteroidal anti-inflammatory drug before the onset of inflammation during surgery will reduce postoperative pain following third molar extraction when compared to the acetaminophen group. Subjects receiving nonsteroidal anti-inflammatory drug will consume less opioid medications compared to those receiving preemptive acetaminophen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tufts University School of Dental Medicine
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

• Patients should be at least 18 years old.

• Subjects for whom a decision has been made to extract at least two third molars classified as full or partially bony impacted in the mandible and/or maxilla in an outpatient setting under ambulatory general anesthesia.

1. Full bony: The entire tooth is below the level of the alveolar bone.

2. Partial bony: A portion of the height of the contour of the tooth is below the level of the alveolar bone.

• Subjects must be physically able to tolerate conventional surgical procedures (ASA I/II)

• Subjects must agree to follow the study protocol.

Exclusion Criteria:

• Subjects who are known to be pregnant or think they may be pregnant. (Female patients will be asked to perform a pregnancy test on the day of surgery to confirm they meet study criteria)

• Subjects with known allergy and/or contradiction to ibuprofen and acetaminophen.

• Subjects with history of alcohol or drug abuse (self-reported).

• Subjects who are currently receiving any anti-inflammatory or pain medication or they suffer from a chronic pain condition.

• Subjects that refuse to participate in the follow up protocol including completing pain diaries.

• Actively infected third molars with swelling, trismus, and/or purulent discharge.

• Subjects for whom the lidocaine with epinephrine is contraindicated (e.g., allergy to drug).