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Local Anesthesia and Analgesics in Endodontic Pain (LAAEP)

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ClinicalTrials.gov Identifier: NCT01982799
Recruitment Status : Withdrawn (Not enough funding)
First Posted : November 13, 2013
Last Update Posted : November 3, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Odontalgia Drug: Oral placebo Drug: Oral ibuprofen Drug: oral naproxen Drug: oral acetaminophen/hydrocodone + ibuprofen

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Local Anesthesia and Analgesics in Post-Operative Endodontic Pain
Study Start Date : February 2014
Primary Completion Date : September 2015
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Endododontic Tx + Long acting local anesthetic
long acting local anesthetic
Drug: Oral placebo
placebo
Drug: Oral ibuprofen
Ibuprofen
Drug: oral naproxen
naproxen
Drug: oral acetaminophen/hydrocodone + ibuprofen
vicodin/ibuprofen
Other Name: Vicodin plus ibuprofen
Experimental: Endodontic Tx plus local anesthetic
local anesthetic
Drug: Oral placebo
placebo
Drug: Oral ibuprofen
Ibuprofen
Drug: oral naproxen
naproxen
Drug: oral acetaminophen/hydrocodone + ibuprofen
vicodin/ibuprofen
Other Name: Vicodin plus ibuprofen


Outcome Measures

Primary Outcome Measures :
  1. Effect of long acting anesthesia and analgesics on endodontic pain [ Time Frame: 36 hours ]
    Pain evaluation time points - pretreatment, after endodontic treatment, 2 hrs after analgesic dosing, following day


Secondary Outcome Measures :
  1. Effect of gender and age on post-operative endodontic pain treatment [ Time Frame: 36 hours ]
    Effect of gender and age will be evaluated based on data from pain evaluation forms


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01982799


Locations
United States, Minnesota
University of Minnesota School of Dentistry
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota, MN
Investigators
Principal Investigator: Walter Bowles, DDS University of Minnesota - Clinical and Translational Science Institute
More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01982799     History of Changes
Other Study ID Numbers: 22245
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Endodontic treatment, analgesics, anesthesia, post-operative pain

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics
Acetaminophen
Ibuprofen
Naproxen
Acetaminophen, hydrocodone drug combination
Analgesics
Hydrocodone
Oxycodone
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gout Suppressants