Local Anesthesia and Analgesics in Endodontic Pain

Local Anesthesia and Analgesics in Post-Operative Endodontic Pain

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01982799

Acronym

LAAEP

Enrollment

Registered

2013-11-13

Start date

2014-02-28

Completion date

2015-09-30

Last updated

2016-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Odontalgia

Keywords

Endodontic treatment, analgesics, anesthesia, post-operative pain

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.

Interventions

DRUGOral placebo

placebo

DRUGOral ibuprofen

Ibuprofen

DRUGoral naproxen

naproxen

DRUGoral acetaminophen/hydrocodone + ibuprofen

vicodin/ibuprofen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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 \-

Design outcomes

Primary

Measure	Time frame	Description
Effect of long acting anesthesia and analgesics on endodontic pain	36 hours	Pain evaluation time points - pretreatment, after endodontic treatment, 2 hrs after analgesic dosing, following day

Secondary

Measure	Time frame	Description
Effect of gender and age on post-operative endodontic pain treatment	36 hours	Effect of gender and age will be evaluated based on data from pain evaluation forms

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026