Post Operative Pain
Conditions
Keywords
Opioids, Pain Management, Analgesics
Brief summary
The purpose of this study is to test protocols being developed for the conduct of a large sale multi-site clinical trial which will compare opioids to non-opioids for managing post-surgical impacted 3rd molar extraction pain.
Detailed description
A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.
Interventions
DRUGOPIOID
Analgesic assignment
DRUGNON-OPIOID
Analgesic assignment
Sponsors
University of Illinois at Chicago
University of Maryland, Baltimore
University of Michigan
University of Rochester
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Analgesic is formulate in capsules. Both OPIOID and NON-OPIOID analgesic formulas are packaged in the same capsules
Intervention model description
A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult men and non-pregnant women who are at least 18 years of age, who are able to refrain from driving or operating heavy machinery while taking the study medication will be able to participate. * Subjects who are English speaking and are able to provide consent will be considered. * Subjects must be in generally good health and able to take ibuprofen, paracetamol (acetaminophen), and hydrocodone.
Exclusion criteria
Subjects who self-report the following history will be excluded from participating: * Individual under the age of 18 * History of gastrointestinal bleeding and/or peptic ulcer * History of renal disease (excluding kidney stones) * History of hepatic disease * History of bleeding disorder * History of respiratory depression * Any prior respiratory effect of an opioid or other anesthetic drug that required respiratory support postoperatively * Active or untreated asthma * History of known allergic reaction to ibuprofen, acetaminophen, hydrocodone, and/or anesthesia * Currently taking any of the following medications: * CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), which may increase plasma concentrations of hydrocodone bitartrate and acetaminophen and prolong opioid adverse reactions, and which may cause potentially fatal respiratory depression * CNS depressants. * Consumes 3 or more alcoholic drinks every day and/or has a history of alcoholism * History of drug or alcohol abuse (excludes marijuana use) * Family history of drug or alcohol abuse in a first degree relative * Has had one or more opioid prescription filled within the past 6 months * Currently pregnant or lactating Patients would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes: * Prior participation in this study * Inability or refusal to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level | 1st day | Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain imaginable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | 1st night | Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible) |
| Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) | 1st day | Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always) The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others? Minimum = 6, Maximum = 30; lower is better and higher is worse outcome |
| Overall Satisfaction | Average for the first seven days post surgery | Subject's rating of overall satisfaction with the analgesic provided after surgery on a 5 point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Opioid Combination analgesic of hydrocodone 5mg/acetaminophen350 mg
OPIOID: Analgesic assignment | 25 |
| Non-Opioid Combination analgesic of ibuprofen 400mgacademinophen 350mg
NON-OPIOID: Analgesic assignment | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not receive intervention | 1 | 2 |
Baseline characteristics
| Characteristic | Opioid | Non-Opioid | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 7 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 18 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 7 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) White | 3 Participants | 11 Participants | 14 Participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 12 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 1 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Pain Level
Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain imaginable)
Time frame: 1st day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opioid | Pain Level | 5.67 score on a scale | Standard Error 0.59 |
| Non-Opioid | Pain Level | 4.09 score on a scale | Standard Error 0.59 |
Primary
Pain Level
Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain
Time frame: Average for the 1st and 2nd day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opioid | Pain Level | 5.10 score on a scale | Standard Error 0.58 |
| Non-Opioid | Pain Level | 3.57 score on a scale | Standard Error 0.58 |
Primary
Pain Level
Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain
Time frame: Average for the first seven days post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opioid | Pain Level | 4.00 score on a scale | Standard Error 0.54 |
| Non-Opioid | Pain Level | 2.74 score on a scale | Standard Error 0.54 |
Secondary
Overall Satisfaction
Subject's rating of overall satisfaction with the analgesic provided after surgery on a 5 point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied)
Time frame: Average for the first seven days post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opioid | Overall Satisfaction | 2.1 score on a scale | Standard Deviation 1.4 |
| Non-Opioid | Overall Satisfaction | 1.7 score on a scale | Standard Deviation 0.89 |
Secondary
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always) The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others? Minimum = 6, Maximum = 30; lower is better and higher is worse outcome
Time frame: Average for the 1st and 2nd day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opioid | Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) | 16.21 score on a scale | Standard Error 1.18 |
| Non-Opioid | Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) | 12.91 score on a scale | Standard Error 1.19 |
Secondary
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always) The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others? Minimum = 6, Maximum = 30; lower is better and higher is worse outcome
Time frame: Average for the 1st, 2nd and 3rd day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opioid | Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) | 15.50 score on a scale | Standard Error 1.15 |
| Non-Opioid | Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) | 12.19 score on a scale | Standard Error 1.16 |
Secondary
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always) The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others? Minimum = 6, Maximum = 30; lower is better and higher is worse outcome
Time frame: Average for the first seven days post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opioid | Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) | 13.74 score on a scale | Standard Error 1.12 |
| Non-Opioid | Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) | 11.01 score on a scale | Standard Error 1.13 |
Secondary
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always) The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others? Minimum = 6, Maximum = 30; lower is better and higher is worse outcome
Time frame: 1st day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opioid | Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) | 17.62 score on a scale | Standard Error 1.27 |
| Non-Opioid | Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b ) | 14.34 score on a scale | Standard Error 1.26 |
Secondary
Sleep Quality
Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)
Time frame: 1st night
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opioid | Sleep Quality | 5.45 score on a scale | Standard Error 0.69 |
| Non-Opioid | Sleep Quality | 3.76 score on a scale | Standard Error 0.7 |
Secondary
Sleep Quality
Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)
Time frame: Average for the 1st, 2nd and 3rd night
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opioid | Sleep Quality | 4.91 score on a scale | Standard Error 0.63 |
| Non-Opioid | Sleep Quality | 3.36 score on a scale | Standard Error 0.63 |
Secondary
Sleep Quality
Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)
Time frame: Average for the first seven nights post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opioid | Sleep Quality | 4.38 score on a scale | Standard Error 0.6 |
| Non-Opioid | Sleep Quality | 2.89 score on a scale | Standard Error 0.6 |
Secondary
Sleep Quality
Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)
Time frame: Average for the 1st and 2nd night
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opioid | Sleep Quality | 5.25 score on a scale | Standard Error 0.64 |
| Non-Opioid | Sleep Quality | 3.44 score on a scale | Standard Error 0.65 |