Percocet vs. Bupivicaine for Toothaches in the ED
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|ClinicalTrials.gov Identifier: NCT02862691|
Recruitment Status : Terminated (Difficulty recruiting patients)
First Posted : August 11, 2016
Last Update Posted : April 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Toothache||Drug: Acetaminophen/Oxycodone (Oral analgesic) Drug: Bupivicaine (Injectable local anesthetic)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparison of the Analgesic Efficacy of Oral Opioid Medication vs. Injected Local Anesthetic in Emergency Department Patients With Toothache|
|Actual Study Start Date :||August 1, 2016|
|Actual Primary Completion Date :||August 1, 2017|
|Actual Study Completion Date :||August 1, 2017|
Active Comparator: Oral analgesic
2 tablets of acetaminophen 325 mg/ oxycodone 5 mg orally once
Drug: Acetaminophen/Oxycodone (Oral analgesic)
2 oral tablets of acetaminophen 325 mg plus oxycodone 5 mg given once
Other Name: Acetaminophen/Oxycodone
Experimental: Injectable local anesthetic
local injection or nerve block with bupivicaine 0.5%
Drug: Bupivicaine (Injectable local anesthetic)
local injection of bupivicaine 0.5% at root of maxillary tooth or nerve block for mandibular tooth
Other Name: Bupivicaine
- Percentage of patients with significant pain relief at the end of the study period [ Time Frame: 60 minutes ]Patients whose pain is reduced from severe (7-10) to mild (0-3) will be considered as having a meaningful reduction in pain.
- Absolute change in pain severity [ Time Frame: 60 minutes ]Calculated by subtracting the 60-minute pain score from the initial pre-treatment pain score
- The time to a 50% reduction in pain severity [ Time Frame: 60 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862691
|United States, New York|
|Stony Brook University Hospital|
|Stony Brook, New York, United States, 11794|
|Principal Investigator:||Adam J Singer, MD||Stony Brook University|