Local Anesthesia and Analgesics in Endodontic Pain (LAAEP)

University of Minnesota (UMN)

Status: Withdrawn

Conditions: Odontalgia

Treatments: Drug: Oral placebo; Drug: oral acetaminophen/hydrocodone + ibuprofen; Drug: Oral ibuprofen; Drug: oral naproxen

Study type: Interventional

Funder types: Other

Identifiers

NCT01982799

22245

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Endododontic Tx + Long acting local anesthetic

Experimental group

Description:

long acting local anesthetic

Treatment:

Drug: Oral ibuprofen

Drug: Oral placebo

Drug: oral naproxen

Drug: oral acetaminophen/hydrocodone + ibuprofen

Endodontic Tx plus local anesthetic

Experimental group

Description:

local anesthetic

Treatment:

Drug: Oral ibuprofen

Drug: Oral placebo

Drug: oral naproxen

Drug: oral acetaminophen/hydrocodone + ibuprofen