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Local Anesthesia and Analgesics in Endodontic Pain (LAAEP)

Primary Purpose

Odontalgia

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral placebo
Oral ibuprofen
oral naproxen
oral acetaminophen/hydrocodone + ibuprofen
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Odontalgia focused on measuring Endodontic treatment, analgesics, anesthesia, post-operative pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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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Sites / Locations

  • University of Minnesota School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Endododontic Tx + Long acting local anesthetic

Endodontic Tx plus local anesthetic

Arm Description

long acting local anesthetic

local anesthetic

Outcomes

Primary Outcome Measures

Effect of long acting anesthesia and analgesics on endodontic pain
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
Effect of gender and age will be evaluated based on data from pain evaluation forms

Full Information

First Posted
October 31, 2013
Last Updated
November 2, 2016
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01982799
Brief Title
Local Anesthesia and Analgesics in Endodontic Pain
Acronym
LAAEP
Official Title
Local Anesthesia and Analgesics in Post-Operative Endodontic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Not enough funding
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Odontalgia
Keywords
Endodontic treatment, analgesics, anesthesia, post-operative pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endododontic Tx + Long acting local anesthetic
Arm Type
Experimental
Arm Description
long acting local anesthetic
Arm Title
Endodontic Tx plus local anesthetic
Arm Type
Experimental
Arm Description
local anesthetic
Intervention Type
Drug
Intervention Name(s)
Oral placebo
Intervention Description
placebo
Intervention Type
Drug
Intervention Name(s)
Oral ibuprofen
Intervention Description
Ibuprofen
Intervention Type
Drug
Intervention Name(s)
oral naproxen
Intervention Description
naproxen
Intervention Type
Drug
Intervention Name(s)
oral acetaminophen/hydrocodone + ibuprofen
Other Intervention Name(s)
Vicodin plus ibuprofen
Intervention Description
vicodin/ibuprofen
Primary Outcome Measure Information:
Title
Effect of long acting anesthesia and analgesics on endodontic pain
Description
Pain evaluation time points - pretreatment, after endodontic treatment, 2 hrs after analgesic dosing, following day
Time Frame
36 hours
Secondary Outcome Measure Information:
Title
Effect of gender and age on post-operative endodontic pain treatment
Description
Effect of gender and age will be evaluated based on data from pain evaluation forms
Time Frame
36 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Bowles, DDS
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota School of Dentistry
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Local Anesthesia and Analgesics in Endodontic Pain

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