Multimodal Analgesic Protocol to Moderate Acute Pain

Prospective, Observational Study With a Multimodal Analgesic Protocol to Moderate Acute Pain After Third Molar Surgery

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.

Study Overview

• Status: Completed
• Conditions: Pain, Post-operative
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7450
      • University of North Carolina School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients scheduled for surgery at UNC oral and maxillofacial surgery clinic

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The impact of the surgery on the patient's post-surgery pain.	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.	14 days

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Glenn Reside, DMD, UNC oral and maxillofacial surgery

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain
• Other Study ID Numbers: 18-0047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No