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Percocet vs. Bupivicaine for Toothaches in the ED

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02862691
Recruitment Status : Terminated (Difficulty recruiting patients)
First Posted : August 11, 2016
Last Update Posted : April 25, 2018
Information provided by (Responsible Party):
Adam Singer, Stony Brook University

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.

Condition or disease Intervention/treatment Phase
Toothache Drug: Acetaminophen/Oxycodone (Oral analgesic) Drug: Bupivicaine (Injectable local anesthetic) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Absolute change in pain severity [ Time Frame: 60 minutes ]
    Calculated by subtracting the 60-minute pain score from the initial pre-treatment pain score

  2. The time to a 50% reduction in pain severity [ Time Frame: 60 minutes ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02862691

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United States, New York
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Stony Brook University
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Principal Investigator: Adam J Singer, MD Stony Brook University

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Responsible Party: Adam Singer, Vice Chairman of Reserach, Stony Brook University Identifier: NCT02862691     History of Changes
Other Study ID Numbers: 901314-2
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Adam Singer, Stony Brook University:

Additional relevant MeSH terms:
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Tooth Diseases
Stomatognathic Diseases
Facial Pain
Neurologic Manifestations
Signs and Symptoms
Anesthetics, Local
Acetaminophen, hydrocodone drug combination
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics, Opioid
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents