drugset / Trial / NCT04008043

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

NCT04008043

Phase 4 Withdrawn Boston University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-02
Primary completion
2021-05
Completion
2021-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 300 mg
Subject Dexamethasone Small molecule 6 mg
Comparator Hydrocodone Unknown 5 mg

Indications

No indication recorded.