Clinical trial NCT04008043: Pilot Study: Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain
Official title: The Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain After Periodontal Surgery Among Patients at the Henry M. Goldman School of Dental Medicine Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Oral Surgery
Keywords: Dexamethasone
Vicodin
Pain management
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Study enrollment rate of eligible participants
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants with breakthrough pain
timeFrame: evening of the surgery, the day after the surgery and one week after the surgery
measure: Number medications taken for breakthrough pain
timeFrame: evening of the surgery, the day after the surgery and one week after the surgery
measure: Medications taken for breakthrough pain
timeFrame: evening of the surgery, the day after the surgery and one week after the surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Henry M. Goldman School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: BU Goldman School of Dental Medicine
name: Sherif Said, BDS
role: PRINCIPAL_INVESTIGATOR
References: