Percocet vs. Bupivicaine for Toothaches in the ED
Primary Purpose
Toothache
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen/Oxycodone (Oral analgesic)
Bupivicaine (Injectable local anesthetic)
Sponsored by
About this trial
This is an interventional treatment trial for Toothache focused on measuring toothache
Eligibility Criteria
Inclusion Criteria:
- Patients who present to the ED with a chief complaint of toothache, and a pain intensity rating of at least a 7 on an 11 item verbal numeric scale (from 0 or no pain to 10 or worst imaginable pain) will be eligible for enrollment.
- Patient should have the capacity to provide informed consent.
Exclusion Criteria:
- Patients presenting with a toothache due to trauma or post-operative procedure will be excluded as well as those requiring drainage of a dental abscess.
- Patients who have any contraindications to the medications used in the study (allergy, history of GI bleeding, etc.).
- Patients who cannot remain in the ED for at least 1 hour after study drug administration or do not have a ride home (if receiving Percocet) will be excluded from the study.
Sites / Locations
- Stony Brook University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Oral analgesic
Injectable local anesthetic
Arm Description
2 tablets of acetaminophen 325 mg/ oxycodone 5 mg orally once
local injection or nerve block with bupivicaine 0.5%
Outcomes
Primary Outcome Measures
Percentage of patients with significant pain relief at the end of the study period
Patients whose pain is reduced from severe (7-10) to mild (0-3) will be considered as having a meaningful reduction in pain.
Secondary Outcome Measures
Absolute change in pain severity
Calculated by subtracting the 60-minute pain score from the initial pre-treatment pain score
The time to a 50% reduction in pain severity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02862691
Brief Title
Percocet vs. Bupivicaine for Toothaches in the ED
Official Title
A Comparison of the Analgesic Efficacy of Oral Opioid Medication vs. Injected Local Anesthetic in Emergency Department Patients With Toothache
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Difficulty recruiting patients
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to compare the speed and adequacy of pain relief in Emergency Department patients with a toothache after an oral analgesic or a local anesthetic administered as a nerve block or by local infiltration.
Detailed Description
All adult patients reporting to the Stony Brook Medical Center Emergency Department with a toothache will be assessed for inclusion criteria. Patients who agree to participate in the study and meet the study criteria will be asked to rate their pain using an 11-item verbal numeric pain scale from 0 to 10, from none to worst. The patient will then be randomized to either two Percocet oral tablets (acetaminophen 325 mg and oxycodone 5 mg), or a single dose of Bupivicaine (as a root block for maxillary teeth or as a local infiltration for mandibular teeth). The intervention given to any particular patient will be determined using a randomization protocol described in Treatment Allocation. The patients will be stratified into depending on whether they have mandibular or maxillary tooth pain in order to account for any difference in outcome based on method of Bupivicaine administration (local block for maxillary teeth and nerve block for mandibular teeth). Half of the included patients will have maxillary toothaches and half will have mandibular toothaches. Administration of additional prescriptions and recommendations will be given as deemed necessary by the dental resident and attending physician (such as antibiotics or additional analgesics).
Measures and Outcomes Following the administration of treatment, the patient will be asked to rate their pain on the verbal numeric pain scale every 5 minutes up to 30 minutes following treatment. The pain of injection will also be measured, immediately following injection on the same pain scale. If after the first 30 minutes the patient still requires additional analgesia, then other analgesic interventions may be given at the discretion of the dental resident and attending physician.
The primary outcome will be the percentage of patients with significant pain relief at the end of the study period of 30 minutes. Patients whose pain is reduced from severe (7-10) to mild (0-3) will be considered as having a meaningful reduction in pain. Secondary outcomes will be the absolute change in pain severity at 30 minutes calculated by subtracting the 30-minute pain score from the initial pre-treatment pain score as well as the time to a 50% reduction in pain severity.
At the end of the trial patient satisfaction with the method of analgesia will be measured on a 5 point Likert scale: extremely dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, and extremely satisfied. Patients will also be asked if they would choose the same treatment for future toothaches.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toothache
Keywords
toothache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral analgesic
Arm Type
Active Comparator
Arm Description
2 tablets of acetaminophen 325 mg/ oxycodone 5 mg orally once
Arm Title
Injectable local anesthetic
Arm Type
Experimental
Arm Description
local injection or nerve block with bupivicaine 0.5%
Intervention Type
Drug
Intervention Name(s)
Acetaminophen/Oxycodone (Oral analgesic)
Other Intervention Name(s)
Acetaminophen/Oxycodone
Intervention Description
2 oral tablets of acetaminophen 325 mg plus oxycodone 5 mg given once
Intervention Type
Drug
Intervention Name(s)
Bupivicaine (Injectable local anesthetic)
Other Intervention Name(s)
Bupivicaine
Intervention Description
local injection of bupivicaine 0.5% at root of maxillary tooth or nerve block for mandibular tooth
Primary Outcome Measure Information:
Title
Percentage of patients with significant pain relief at the end of the study period
Description
Patients whose pain is reduced from severe (7-10) to mild (0-3) will be considered as having a meaningful reduction in pain.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Absolute change in pain severity
Description
Calculated by subtracting the 60-minute pain score from the initial pre-treatment pain score
Time Frame
60 minutes
Title
The time to a 50% reduction in pain severity
Time Frame
60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who present to the ED with a chief complaint of toothache, and a pain intensity rating of at least a 7 on an 11 item verbal numeric scale (from 0 or no pain to 10 or worst imaginable pain) will be eligible for enrollment.
Patient should have the capacity to provide informed consent.
Exclusion Criteria:
Patients presenting with a toothache due to trauma or post-operative procedure will be excluded as well as those requiring drainage of a dental abscess.
Patients who have any contraindications to the medications used in the study (allergy, history of GI bleeding, etc.).
Patients who cannot remain in the ED for at least 1 hour after study drug administration or do not have a ride home (if receiving Percocet) will be excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam J Singer, MD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Percocet vs. Bupivicaine for Toothaches in the ED
We'll reach out to this number within 24 hrs