Percocet vs. Bupivicaine for Toothaches in the ED

NCT ID: NCT02862691

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-01
• Study Completion Date: 2017-08-01

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.

Conditions

Toothache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral analgesic

2 tablets of acetaminophen 325 mg/ oxycodone 5 mg orally once

Group Type: ACTIVE_COMPARATOR

Acetaminophen/Oxycodone (Oral analgesic)

Intervention Type: DRUG

2 oral tablets of acetaminophen 325 mg plus oxycodone 5 mg given once

Injectable local anesthetic

local injection or nerve block with bupivicaine 0.5%

Group Type: EXPERIMENTAL

Bupivicaine (Injectable local anesthetic)

Intervention Type: DRUG

local injection of bupivicaine 0.5% at root of maxillary tooth or nerve block for mandibular tooth

Interventions

Acetaminophen/Oxycodone (Oral analgesic)

2 oral tablets of acetaminophen 325 mg plus oxycodone 5 mg given once

Intervention Type: DRUG

Bupivicaine (Injectable local anesthetic)

local injection of bupivicaine 0.5% at root of maxillary tooth or nerve block for mandibular tooth

Intervention Type: DRUG

Other Intervention Names

Acetaminophen/Oxycodone; Bupivicaine

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Adam Singer

Vice Chairman of Reserach

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam J Singer, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Stony Brook University Hospital

Stony Brook, New York, United States

Countries

United States

Other Identifiers

901314-2

Identifier Type: -

Identifier Source: org_study_id