Local Anesthesia and Analgesics in Endodontic Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Local Anesthesia and Analgesics in Post-Operative Endodontic Pain

Conditions
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Odontalgia

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


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endododontic Tx + Long acting local anesthetic<br>long acting local anesthetic | Drug: Oral placebo<br>* placebo<br>Drug: Oral ibuprofen<br>* Ibuprofen<br>Drug: oral naproxen<br>* naproxen<br>Drug: oral acetaminophen/hydrocodone + ibuprofen<br>* vicodin/ibuprofen<br>* Other names: Vicodin plus ibuprofen;|
| Experimental: Endodontic Tx plus local anesthetic<br>local anesthetic | Drug: Oral placebo<br>* placebo<br>Drug: Oral ibuprofen<br>* Ibuprofen<br>Drug: oral naproxen<br>* naproxen<br>Drug: oral acetaminophen/hydrocodone + ibuprofen<br>* vicodin/ibuprofen<br>* Other names: Vicodin plus ibuprofen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 36 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endodontic treatment, analgesics, anesthesia, post-operative pain