Local Anesthesia and Analgesics in Endodontic Pain

Not Applicable

Withdrawn

• Conditions: Odontalgia
• Interventions: Drug: Oral placebo; Drug: Oral ibuprofen; Drug: oral naproxen; Drug: oral acetaminophen/hydrocodone + ibuprofen

• Registration Number: NCT01982799
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-10-31
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-13
• Study Start: 2014-02
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endododontic Tx + Long acting local anesthetic	Oral placebo	long acting local anesthetic
Endododontic Tx + Long acting local anesthetic	Oral ibuprofen	long acting local anesthetic
Endododontic Tx + Long acting local anesthetic	oral naproxen	long acting local anesthetic
Endododontic Tx + Long acting local anesthetic	oral acetaminophen/hydrocodone + ibuprofen	long acting local anesthetic
Endodontic Tx plus local anesthetic	oral acetaminophen/hydrocodone + ibuprofen	local anesthetic
Endodontic Tx plus local anesthetic	Oral placebo	local anesthetic
Endodontic Tx plus local anesthetic	Oral ibuprofen	local anesthetic
Endodontic Tx plus local anesthetic	oral naproxen	local anesthetic

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Minnesota School of Dentistry; 🇺🇸 Minneapolis, Minnesota, United States