Multimodal Analgesic Protocol to Moderate Acute Pain

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Recruiting
CT.gov ID
NCT03456141
Collaborator
(none)
100
1
55
1.8

Study Details

Study Description

Brief Summary

With a prospective, observational study assess post-surgery pain levels and patient's use of opioids and other analgesic drugs to moderate pain following third molar surgery.

Condition or Disease Intervention/Treatment Phase
  • Procedure: third molar surgery

Detailed Description

SPECIFIC AIMS Using the UNC surgery clinic multi-modal protocol of drugs/dosages to control acute pain after third molar surgery assess each post-surgery day(PSD) the patient reported

  1. pain levels post-surgery as recorded by Likert-type and Gracely scales

  2. quality of life(QOL) outcomes for lifestyle and oral function

  3. number of opioid doses taken by subject-patients

  4. number of NSAID and acetaminophen doses taken by subject-patients.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Prospective, Observational Study With a Multimodal Analgesic Protocol to Moderate Acute Pain After Third Molar Surgery
Actual Study Start Date :
Mar 1, 2018
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Outcome Measures

Primary Outcome Measures

  1. The impact of the surgery on the patient's post-surgery pain. [14 days]

    Likert scales for average pain and worst pain are assessed with 7-point scales with verbal anchors of "no pain" and "worst pain imagined". Recovery for pain on the Likert scales is defined as the number of PSD until the patient reports a score of 1 or 2 on the 7-point scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • ASA I,II At least two lower 3rd molars scheduled for removal
Exclusion Criteria:
  • Patient being treated for opioid addiction/abuse including having Rx for suboxone, methadone

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of North Carolina School of Dentistry Chapel Hill North Carolina United States 27599-7450

Sponsors and Collaborators

  • University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Glenn Reside, DMD, UNC oral and maxillofacial surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT03456141
Other Study ID Numbers:
  • 18-0047
First Posted:
Mar 7, 2018
Last Update Posted:
Apr 14, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2022