Phenotyping Acute Pain for Discovery Research and Directed Therapeutics

NCT02322996 | Withdrawn

• 1 other identifier: 14-001670
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the current study is to combine existing and new tools for quantifying patient self-report to characterize changes in acute pain. The ability to quantitatively measure self-report provides behavioral pain phenotypes that can serve as the basis for clustering patients into sub-groups based on their self-report of their symptoms, eliminating observer based perceptions of patients' pain.

Conditions

Post op Pain

Outcome Measures

Primary Outcomes (1)

• characterize changes in acute pain

  The goal of the current study is to combine existing and new tools for quantifying patient self-report to characterize changes in acute pain

  48 hours

Study Arms (1)

open label

After the surgery and the onset of moderate-severe pain, QST and PROMIS questionnaires will be repeated. Throughout these procedures, patients will rate their pain perception using a numeric rating scale. Approximately 2-3 hours after surgery at the onset of moderate pain, the rescue analgesic (toradol) will be administered via intramuscular injection. Again, QST and PROMIS protocols will be repeated after the drug is given and when patients report pain relief. A standard naproxen dose of 500 mg will be given to patients upon leaving the clinic and they will be instructed to take one pill orally each day before returning for evaluation after 48 hours.

Other: questionnaires

Interventions

questionnaires OTHER

The deep phenotyping of acute pain will be conducted using the oral surgery model. Before surgery, subjects will undergo QST and answer short-form questionnaires related to pain and activities of daily living.

open label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or females over 18 years of age

You may qualify if:

• Male and female patients aged 18 and older willing to undergo clinically indicated non-emergent oral surgery for the removal of impacted third molars with local anesthesia
• Indicated for the removal of third molars, at least a minimum of one partial-bony impacted third molar, with a total difficulty score total of not less than 4\*
• Communicate in spoken and written English
• Willing to undergo research observation for 4 hours postoperatively and 48 hour follow up visit
• In good health with an ASA status of 1 or 2 by self report and review of medical history
• Self-report of moderate or severe pain on a categorical scale with a minimum of 4 out of 10 on the numerical rating scale following the offset of local anesthesia
• =erupted, 2=soft tissue impaction, 3=partial bony impaction, 4=full bony impaction, 5 = unusual surgical difficulty

You may not qualify if:

• Current or history of mental disorder or substance abuse
• Allergy to aspirin, NSAIDS, or sulfonamide
• Pregnant and/or nursing
• History of peptic ulcers and/or GI bleeding
• Concurrent use of agents which may obscure pain report, e.g., alcohol, opioids, benzodiazepines, and depressants, etc
• Chronic use of medications confounding assessment of the inflammatory response or analgesia, e.g., antihistamines, NSAIDS, steroids, antidepressants

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

School of Dental Medicine At East Carolina University

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Raymond Dionne, DDS

  School of Dental Medicine at East Carolina University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Raymond A. Dionne, DDS, PhD Research Professor Department of Pharmacology & Toxicology Brody School of Medicine Department of Foundational Sciences School of Dental Medicine East Carolina University Greenville, NC 27834-4354

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 23, 2014
• Study Start: February 21, 2018
• Primary Completion: February 21, 2018
• Study Completion: February 21, 2018
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

US (1)