Pilot Study: Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain

• Status: Withdrawn
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of the pilot study is to investigate the process that includes recruitment (to estimate the rate of enrollment), feasibility, protocol refinement, and willingness of the subject to be randomized. To provide a sample estimate of the population parameter which is the true value in the target population to be used in the planning of a larger confirmatory study.

Secondary objectives include:

To examine the efficacy of pre/post-operational administration of dexamethasone vs Vicodin (acetaminophen and hydrocodone) for post-operative pain control following periodontal surgery at the Henry M. Goldman School of Dental Medicine.

To examine how BMI alters the response to dexamethasone and hydrocodone following periodontal surgery since obese patients have shown higher pain scores and increased pain sensitivity in previous experimental models of pain.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston University
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; BB 1101; Dexamethasone; Dexamethasone acetate; Hydrocodone; Oxycodone

Criteria

Inclusion Criteria:

• Must be scheduled for periodontal surgery

• Subjects must be aged 21 years old and above

• Able and willing to provide informed consent

• 20 non-obese patients with BMI less than 30kg/m2

• 20 obese patients with BMI greater than or equal to 30kg/m2

• Diabetic and hypertensive patients included

Exclusion Criteria:

• Patients allergic to any formulations used in the study

• Patients with chronic use of nonsteroidal anti-inflammatory drugs or chronic use of narcotics; chronic defined as frequent use or misuse/ abuse so much as once a month

• Pregnant or lactating female patients; pregnancy test will be performed alongside the medical history

• Patients with kidney dysfunction

• Patients at risk for infective endocarditis determined by the medical history or past medical records