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CompletedNCT03456141Updated Feb 23, 2023

Multimodal Analgesic Protocol to Moderate Acute Pain

An observational study in Pain, Post-operative, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-23.

Sponsored by University of North Carolina, Chapel Hill · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Pain, Post-operative
03

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients scheduled for surgery at UNC oral and maxillofacial surgery clinic

Inclusion criteria

  • ASA I,II At least two lower 3rd molars scheduled for removal

Exclusion criteria

Exclusion Criteria:

  • Patient being treated for opioid addiction/abuse including having Rx for suboxone, methadone
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Interventions

  • Procedurethird 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 14 days

06

Study locations

1 site
  • University of North Carolina School of Dentistry
    Chapel Hill, North Carolina 27599-7450, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03456141
Lead sponsor
University of North Carolina, Chapel Hill
Responsible party
Sponsor
First posted
Mar 7, 2018
Start date
Mar 1, 2018
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Feb 23, 2023

Study contacts

Glenn Reside, DMD
principal investigator · UNC oral and maxillofacial surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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