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出境医 / 临床实验 / Pilot Study: Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain
Pilot Study: Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Oral Surgery | Drug: Vicodin Drug: Dexamethasone | Phase 4 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Estimated Study Start Date : | February 2020 |
| Estimated Primary Completion Date : | May 2021 |
| Estimated Study Completion Date : | May 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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.
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Drug: 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.
Other Name: corticosteroid
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Active Comparator: 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.
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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.
Other Name: acetaminophen and hydrocodone
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Outcome Measures
Primary Outcome Measures :
- Study enrollment rate of eligible participants [ Time Frame: 12 months ]The proportion of patients that provide consent for the study
Secondary Outcome Measures :
- Number of participants with breakthrough pain [ Time Frame: evening of the surgery, the day after the surgery and one week after the surgery ]
- Number medications taken for breakthrough pain [ Time Frame: evening of the surgery, the day after the surgery and one week after the surgery ]
- Medications taken for breakthrough pain [ Time Frame: evening of the surgery, the day after the surgery and one week after the surgery ]
Eligibility Criteria
| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Locations
| United States, Massachusetts | |
| Henry M. Goldman School of Dental Medicine | |
| Boston, Massachusetts, United States, 02118 | |
Sponsors and Collaborators
Boston University
Investigators
| Principal Investigator: | Sherif Said, BDS | BU Goldman School of Dental Medicine |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 2, 2019 | ||||||
| First Posted Date ICMJE | July 5, 2019 | ||||||
| Last Update Posted Date | November 13, 2019 | ||||||
| Estimated Study Start Date ICMJE | February 2020 | ||||||
| Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Study enrollment rate of eligible participants [ Time Frame: 12 months ] The proportion of patients that provide consent for the study
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| Original Primary Outcome Measures ICMJE |
Study enrollment rate of eligible participants [ Time Frame: 12 months ] | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Pilot Study: Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain | ||||||
| Official Title ICMJE | 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 | ||||||
| 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. |
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| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 4 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Oral Surgery | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Withdrawn | ||||||
| Actual Enrollment ICMJE |
0 | ||||||
| Original Estimated Enrollment ICMJE |
40 | ||||||
| Estimated Study Completion Date ICMJE | May 2021 | ||||||
| Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 21 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04008043 | ||||||
| Other Study ID Numbers ICMJE | H-38061 | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Boston University | ||||||
| Study Sponsor ICMJE | Boston University | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Boston University | ||||||
| Verification Date | November 2019 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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