Local Anesthesia and Analgesics in Endodontic Pain

Odontalgia Clinical Trial

— LAAEP  

Official title:

Local Anesthesia and Analgesics in Post-Operative Endodontic Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01982799
• Other study ID #: 22245
• Status: Withdrawn
• Phase: N/A
• First received: October 31, 2013
• Last updated: November 2, 2016
• Start date: February 2014
• Est. completion date: September 2015

Study information

• Verified date: November 2016
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Odontalgia
• Toothache

Intervention

Drug:
• Oral placebo
placebo
• Oral ibuprofen
Ibuprofen
• oral naproxen
naproxen
• oral acetaminophen/hydrocodone + ibuprofen
vicodin/ibuprofen

Locations

Country	Name	City	State
United States	University of Minnesota School of Dentistry	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	University of Minnesota, MN

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No