Overview

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

Status:
Withdrawn
Trial end date:
2021-05-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Boston University
Treatments:
Acetaminophen
Acetaminophen, hydrocodone drug combination
BB 1101
Dexamethasone
Dexamethasone acetate
Hydrocodone
Oxycodone