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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
53
Analgesic assignment
Analgesic assignment
University of Illinois Chicago
Chicago, Illinois, United States
University of Maryland
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Rutgers University
Newark, New Jersey, United States
Pain Level
Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain imaginable)
Time frame: 1st day
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
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
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
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
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
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
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University of Rochester
Rochester, New York, United States
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
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
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
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
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