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

NCT04008043 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: H-38061
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Surgery

Keywords

Dexamethasone; Vicodin; Pain management

Outcome Measures

Primary Outcomes (1)

• Study enrollment rate of eligible participants

  The proportion of patients that provide consent for the study

  12 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Dexamethasone

EXPERIMENTAL

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.

Drug: Dexamethasone

Vicodin

ACTIVE COMPARATOR

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.

Drug: Vicodin

Interventions

Vicodin DRUG

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.

Also known as: acetaminophen and hydrocodone

Vicodin

Dexamethasone DRUG

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.

Also known as: corticosteroid

Dexamethasone

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be scheduled for periodontal surgery
• Subjects must be aged 21 years old and above
• Able and willing to provide informed consent
• non-obese patients with BMI less than 30kg/m2
• obese patients with BMI greater than or equal to 30kg/m2
• Diabetic and hypertensive patients included

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Henry M. Goldman School of Dental Medicine

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

acetaminophen, hydrocodone drug combination; Dexamethasone; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Sherif Said, BDS

  BU Goldman School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: February 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)