Back to resultsPilot Study: Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain
Primary Purpose
Oral Surgery
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vicodin
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Oral Surgery focused on measuring Dexamethasone, Vicodin, Pain management
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
Sites / Locations
- Henry M. Goldman School of Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dexamethasone
Vicodin
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Study enrollment rate of eligible participants
The proportion of patients that provide consent for the study
Secondary Outcome Measures
Number of participants with breakthrough pain
Number medications taken for breakthrough pain
Medications taken for breakthrough pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04008043
Brief Title
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
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Inadequate resources to start the study at this site.
Study Start Date
February 2020 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Surgery
Keywords
Dexamethasone, Vicodin, Pain management
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
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.
Arm Title
Vicodin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vicodin
Other Intervention Name(s)
acetaminophen and hydrocodone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
corticosteroid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Study enrollment rate of eligible participants
Description
The proportion of patients that provide consent for the study
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of participants with breakthrough pain
Time Frame
evening of the surgery, the day after the surgery and one week after the surgery
Title
Number medications taken for breakthrough pain
Time Frame
evening of the surgery, the day after the surgery and one week after the surgery
Title
Medications taken for breakthrough pain
Time Frame
evening of the surgery, the day after the surgery and one week after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif Said, BDS
Organizational Affiliation
BU Goldman School of Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry M. Goldman School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study: Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain
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