Study Stopped
Difficulty recruiting patients
Percocet vs. Bupivicaine for Toothaches in the ED
A Comparison of the Analgesic Efficacy of Oral Opioid Medication vs. Injected Local Anesthetic in Emergency Department Patients With Toothache
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2016
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 8, 2016
CompletedFirst Posted
Study publicly available on registry
August 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedApril 25, 2018
April 1, 2018
1 year
August 8, 2016
April 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
60 minutes
Secondary Outcomes (2)
Absolute change in pain severity
60 minutes
The time to a 50% reduction in pain severity
60 minutes
Study Arms (2)
Oral analgesic
ACTIVE COMPARATOR2 tablets of acetaminophen 325 mg/ oxycodone 5 mg orally once
Injectable local anesthetic
EXPERIMENTALlocal injection or nerve block with bupivicaine 0.5%
Interventions
2 oral tablets of acetaminophen 325 mg plus oxycodone 5 mg given once
local injection of bupivicaine 0.5% at root of maxillary tooth or nerve block for mandibular tooth
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam J Singer, MD
Stony Brook University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Chairman of Reserach
Study Record Dates
First Submitted
August 8, 2016
First Posted
August 11, 2016
Study Start
August 1, 2016
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
April 25, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will share