Multimodal Analgesic Protocol to Moderate Acute Pain

Pain, Post-operative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03456141
• Other study ID #: 18-0047
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2022
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain, Post-operative
• Pain, Postoperative

Intervention

Procedure:
• third molar surgery
The patient is asked to complete the diary each post-surgery day for 14 days. Recovery is organized into three QOL domains: lifestyle, oral function, and pain.

Locations

Country	Name	City	State
United States	University of North Carolina School of Dentistry	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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