Post op PainNCT02322996
Phenotyping Acute Pain for Discovery Research and Directed Therapeutics
An observational study of Post op Pain, run by East Carolina University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post op Pain
- What is being tested?
- questionnaires
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2018to 21 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male or females over 18 years of age
Who may be able to join
- 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
- 1=erupted, 2=soft tissue impaction, 3=partial bony impaction, 4=full bony impaction, 5 = unusual surgical difficulty
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Dental Medicine At East Carolina University
Greenville, North Carolina, 27834
About this study
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.
Read the detailed description
Pain is a therapeutic challenge as well as a public health problem that is estimated to affect over 116 million American adults [1]; reduces quality of life; and is estimated to cost up to $635 billion annually. Growing recognition of the need for evidence-based, individual-centered treatment strategies raises expectations that health care will be improved by matching proven effective treatments with knowledge of patients' unique characteristics to optimize efficacy and safety. Essential to the goal of matching treatments to patients to enhance analgesic drug development and therapy is identification of intermediate phenotypes that capture the mechanistic complexity, genetic expression and epigenetic changes of hundreds of ongoing processes and mediators that influence treatment efficacy and safety and may form the basis for differential responses to drug therapy. The ability to identify functional variants in the genomic responses to pain and therapeutics at the sub-group and patient levels, however, has been limited to date by lack of thorough phenotyping for patients with pain.
The need for a more comprehensive understanding of human phenotypes has spawned a new method of phenotyping studies referred to as "deep phenotyping." Deep phenotyping for pharmacogenomic studies requires both breath and depth to better interpret the complexities of genomic variations that may underlie individual differences in pain report. One approach to address this complexity is to use quantitative testing of clinical features to identify more homogeneous subsets within a group of patients with a given diagnosis or characteristic. Variations in quantitative measures may identify intermediate phenotypes that are genetically less complex yet have potentially stronger signals closer to the site of gene action. In pain, quantitative testing is often termed "quantitative sensory testing", or QST.
Exclusion
- 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
- Concurrent or history of chronic diseases, e.g., diabetes, rheumatoid arthritis, liver disease, cancer, hypertension or obesity (body mass index >35)
- Expectation of excessive surgical difficulty, resulting in a difficulty score of 5 for any tooth (determined from panoramic radiograph)
- Subjects with extreme anxiety and who are candidates for general anesthesia or conscious sedation
- Conditions
- Post op Pain
- Being tested
- questionnaires
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study start21 Feb 2018
- Primary completion21 Feb 2018
- Study completion21 Feb 2018
Why it stopped: never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post op PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Dionne, East Carolina University
- Investigators
- Raymond Dionne, DDS, Principal investigator, School of Dental Medicine at East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322996
- Sponsor's protocol ID
- 14-001670
- Status last verified
- Feb 2018
- First submitted
- 10 Dec 2014
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping Acute Pain for Discovery Research and Directed Therapeutics
- ClinicalTrials.gov ID
- NCT02322996
- Acronym / sponsor ID
- 14-001670
- Conditions
- Post op Pain
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 21 Feb 2018 (actual)
- Study completion
- 21 Feb 2018 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pain is a therapeutic challenge as well as a public health problem that is estimated to affect over 116 million American adults [1]; reduces quality of life; and is estimated to cost up to $635 billion annually. Growing recognition of the need for evidence-based, individual-centered treatment strategies raises expectations that health care will be improved by matching proven effective treatments with knowledge of patients' unique characteristics to optimize efficacy and safety. Essential to the goal of matching treatments to patients to enhance analgesic drug development and therapy is identification of intermediate phenotypes that capture the mechanistic complexity, genetic expression and epigenetic changes of hundreds of ongoing processes and mediators that influence treatment efficacy and safety and may form the basis for differential responses to drug therapy. The ability to identify functional variants in the genomic responses to pain and therapeutics at the sub-group and patient levels, however, has been limited to date by lack of thorough phenotyping for patients with pain.
The need for a more comprehensive understanding of human phenotypes has spawned a new method of phenotyping studies referred to as "deep phenotyping." Deep phenotyping for pharmacogenomic studies requires both breath and depth to better interpret the complexities of genomic variations that may underlie individual differences in pain report. One approach to address this complexity is to use quantitative testing of clinical features to identify more homogeneous subsets within a group of patients with a given diagnosis or characteristic. Variations in quantitative measures may identify intermediate phenotypes that are genetically less complex yet have potentially stronger signals closer to the site of gene action. In pain, quantitative testing is often termed "quantitative sensory testing", or QST.
Exclusion
- 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
- Concurrent or history of chronic diseases, e.g., diabetes, rheumatoid arthritis, liver disease, cancer, hypertension or obesity (body mass index >35)
- Expectation of excessive surgical difficulty, resulting in a difficulty score of 5 for any tooth (determined from panoramic radiograph)
- Subjects with extreme anxiety and who are candidates for general anesthesia or conscious sedation
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label | – | Other: questionnairesAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male or females over 18 years of age
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesThe 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. | Other | open label |
Primary outcome
characterize changes in acute pain
Time frame: 48 hours
The goal of the current study is to combine existing and new tools for quantifying patient self-report to characterize changes in acute pain
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Dionne, DDS principal investigator
School of Dental Medicine at East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post op Pain, run by East Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
characterize changes in acute pain (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.