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Local Anesthesia and Analgesics in Endodontic Pain

NCT ID: NCT01982799

Last Updated: 2016-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-09-30

Brief Summary

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For patients with a toothache, is pain relief after root canal procedure improved using long acting local anesthetic and analgesics? The purpose of this clinical trial is the investigate the effect of long acting local anesthetic with 1 of 4 oral medication groups, on post-operative endodontic pain.

Detailed Description

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Patients (n=220) presenting to the University of Minnesota Endodontic clinic, with moderate to severe pain from toothache requiring root canal treatment ,will be invited to participate in the study. The endodontic treatment is NOT part of the research. Patients will complete pain evaluation forms and take 2 doses of prescribed medication. Normally after a root canal procedure, patients will be suggested to take over-the-counter ibuprofen if needed, or prescribed an analgesic if they are having severe pain. We will be randomizing patients in double blind manner to receive regular or long acting local anesthesia and post-op medications (placebo or 1 of 3 analgesics), with the patient evaluating their pain before starting root canal (pre-treatment pain), after root canal, after analgesics and during the following day.

Conditions

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Odontalgia

Keywords

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Endodontic treatment, analgesics, anesthesia, post-operative pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Endododontic Tx + Long acting local anesthetic

long acting local anesthetic

Group Type EXPERIMENTAL

Oral placebo

Intervention Type DRUG

placebo

Oral ibuprofen

Intervention Type DRUG

Ibuprofen

oral naproxen

Intervention Type DRUG

naproxen

oral acetaminophen/hydrocodone + ibuprofen

Intervention Type DRUG

vicodin/ibuprofen

Endodontic Tx plus local anesthetic

local anesthetic

Group Type EXPERIMENTAL

Oral placebo

Intervention Type DRUG

placebo

Oral ibuprofen

Intervention Type DRUG

Ibuprofen

oral naproxen

Intervention Type DRUG

naproxen

oral acetaminophen/hydrocodone + ibuprofen

Intervention Type DRUG

vicodin/ibuprofen

Interventions

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Oral placebo

placebo

Intervention Type DRUG

Oral ibuprofen

Ibuprofen

Intervention Type DRUG

oral naproxen

naproxen

Intervention Type DRUG

oral acetaminophen/hydrocodone + ibuprofen

vicodin/ibuprofen

Intervention Type DRUG

Other Intervention Names

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Vicodin plus ibuprofen

Eligibility Criteria

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Inclusion Criteria

18-65 y.o. American Society of Anesthesiologists physical classification I or II Can understand and complete pain evaluation forms tooth pain (\>3 out of 10) needing root canal Ability to read and provide informed consent Must be able to swallow tablets

Exclusion Criteria

Allergy/intolerance to analgesics (ibuprofen, naproxen, vicodin) Patients who are pregnant Patients currently on pain medications for an unrelated condition Patients unwilling to fill out pain scales Liver or kidney disease Unable to understand and complete consent form and pain evaluation forms

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Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Walter Bowles, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota School of Dentistry

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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22245

Identifier Type: -

Identifier Source: org_study_id