Percocet vs. Bupivicaine for Toothaches in the ED



Status:Terminated
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - Any
Updated:4/27/2018
Start Date:August 1, 2016
End Date:August 1, 2017

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A Comparison of the Analgesic Efficacy of Oral Opioid Medication vs. Injected Local Anesthetic in Emergency Department Patients With Toothache

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.

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.

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.
We found this trial at
1
site
Stony Brook, New York 11794
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Stony Brook, NY
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