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

Oral Surgery Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04008043
• Other study ID #: H-38061
• Status: Withdrawn
• Phase: Phase 4
• Start date: February 2020
• Est. completion date: May 2021

Study information

• Verified date: November 2019
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oral Surgery
• Pain, Postoperative

Intervention

Drug:
• Vicodin
In addition to taking one tablet of vicodin for pain every 4-6 hours up to 8 tablets, pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.
• Dexamethasone
In addition to taking one tablet of dexamethasone for pain beginning the day before surgery and on the day of surgery, pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.

Locations

Country	Name	City	State
United States	Henry M. Goldman School of Dental Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study enrollment rate of eligible participants	The proportion of patients that provide consent for the study	12 months
Secondary	Number of participants with breakthrough pain		evening of the surgery, the day after the surgery and one week after the surgery
Secondary	Number medications taken for breakthrough pain		evening of the surgery, the day after the surgery and one week after the surgery
Secondary	Medications taken for breakthrough pain		evening of the surgery, the day after the surgery and one week after the surgery