Multimodal Analgesic Protocol to Moderate Acute Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03456141
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : November 14, 2018
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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
Pain, Post-operative 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
Estimated Enrollment : 35 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 : March 1, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : May 2019

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. The impact of the surgery on the patient's post-surgery pain. [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03456141

Contact: Glenn Reside, DMD 919-537-3944
Contact: Raymond White, DDS, PhD 919-537-3944

United States, North Carolina
University of North Carolina School of Dentistry Recruiting
Chapel Hill, North Carolina, United States, 27599-7450
Contact: Raymond P White Jr, DDS, PhD    919-537-3944   
Contact: Glenn Reside, DDS    919-537-3944   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Principal Investigator: Glenn Reside, DMD UNC oral and maxillofacial surgery

Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT03456141     History of Changes
Other Study ID Numbers: 18-0047
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Acute Pain
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs