Local Anesthesia and Analgesics in Endodontic Pain (LAAEP)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01982799
First received: October 31, 2013
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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 Intervention
Odontalgia
Drug: Oral placebo
Drug: Oral ibuprofen
Drug: oral naproxen
Drug: oral acetaminophen/hydrocodone + ibuprofen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Official Title: Local Anesthesia and Analgesics in Post-Operative Endodontic Pain

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Effect of long acting anesthesia and analgesics on endodontic pain [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
    Pain evaluation time points - pretreatment, after endodontic treatment, 2 hrs after analgesic dosing, following day


Secondary Outcome Measures:
  • Effect of gender and age on post-operative endodontic pain treatment [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
    Effect of gender and age will be evaluated based on data from pain evaluation forms


Estimated Enrollment: 200
Study Start Date: December 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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

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  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982799

Contacts
Contact: Walter R Bowles, PhD DDS 512-624-9613 bowle001@umn.edu
Contact: Jane Schwensohn 612-624-9900 schwe008@umn.edu

Locations
United States, Minnesota
University of Minnesota School of Dentistry Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Walter R Bowles, DDS PhD    612-624-9613    bowle001@umn.edu   
Contact: Jane Schwensohn    612-624-9900    schwe008@umn.edu   
Principal Investigator: Walter R Bowles, DDS PhD         
Sub-Investigator: Steven Wiswall, DDS         
Sub-Investigator: Riley Lewis, DDS         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Walter Bowles, DDS University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01982799     History of Changes
Other Study ID Numbers: 22245
Study First Received: October 31, 2013
Last Updated: November 13, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Acetaminophen
Acetaminophen, hydrocodone drug combination
Analgesics
Anesthetics
Anesthetics, Local
Ibuprofen
Oxycodone
Analgesics, Non-Narcotic
Analgesics, Opioid
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Central Nervous System Agents
Central Nervous System Depressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014