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

Phase 4

Withdrawn

• Conditions: Oral Surgery
• Interventions: Drug: Vicodin; Drug: Dexamethasone

• Registration Number: NCT04008043
• Lead Sponsor: Boston University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-11
• Last Update Posted: 2019-11-13
• Study Start: 2020-02
• Primary Completion: 2021-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vicodin	Vicodin	Participants in this arm will take a vicodin tablet every 4-6 hrs as needed to a maximum of 8 tablets after surgery. Each tablet has 300 mg acetaminophen and 5 mg hydrocodone. Pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.
Dexamethasone	Dexamethasone	Participants in this arm will take a 6mg dexamethasone tablet the day before surgery, a 6 mg tablet the day of surgery, a 4mg tablet the day after surgery and a 2mg tablet the second day after surgery. Pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.

Primary Outcome Measures

Name	Time	Method
Study enrollment rate of eligible participants	12 months	The proportion of patients that provide consent for the study

Secondary Outcome Measures

Name	Time	Method
Number of participants with breakthrough pain	evening of the surgery, the day after the surgery and one week after the surgery
Number medications taken for breakthrough pain	evening of the surgery, the day after the surgery and one week after the surgery
Medications taken for breakthrough pain	evening of the surgery, the day after the surgery and one week after the surgery

Trial Locations

Locations (1)

Henry M. Goldman School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States