Acetaminophen/Codeine vs Acetaminophen/Ibuprofen for Pain Control and Patient Satisfaction After Hand Surgery
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|ClinicalTrials.gov Identifier: NCT02647788|
Recruitment Status : Recruiting
First Posted : January 6, 2016
Last Update Posted : July 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Acetaminophen/Ibuprofen Drug: Acetaminophen/Codeine||Phase 4|
To establish, through a randomized control trial, whether post-operative Acetaminophen and Ibuprofen (non-opioid regimen) would provide equivalent post-operative analgesia to ambulatory hand surgery patients compared to Acetaminophen and Codeine (opioid regimen).
To establish whether the opioid versus non-opioid post-operative pain regimen influences patient satisfaction.
Sixty-three patients enrolled for each group (non-opioid and opioid). Approximately 145 patients will be required to achieve complete data for 63 patients in each group (assuming 15% lost to follow-up & failure to comply with study protocol).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Pilot Study, Blinded Randomized Control Trial, Single Center Study to Compare Acetaminophen & Codeine Versus Ibuprofen/Acetaminophen for Pain Control and Patient Satisfaction After Ambulatory Hand Surgery|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||July 2018|
Active Comparator: Acetaminophen/Ibuprofen
Group 1: Acetaminophen 650 mg; Ibuprofen 400 mg
After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit
Other Name: Tylenol/Advil
Active Comparator: Acetaminophen/Codeine
Group 2: Acetaminophen 300mg, Codeine 30 mg
After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit
Other Name: Tylenol 3
- Assessing change in pain using the Visual Analogue Scale Pain Score [ Time Frame: 3 times a day each day after hand surgery (at dinner time, before going to sleep and in the middle of the night), until post-op appointment (between 4 and 8 days after surgery) ]To establish, through a randomized control trial, whether post-operative Acetaminophen and Ibuprofen (non-opioid regimen) would provide equivalent post-operative analgesia to ambulatory hand surgery patients compared to Acetaminophen and Codeine (opioid regimen).
- Quality of Recovery-9 (QoR-9). [ Time Frame: Postoperative Day 2 ]To establish whether the opioid versus non-opioid post-operative pain regimen influences patient satisfaction through Quality of Recovery (QoR) scores in ambulatory hand surgery.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647788
|Contact: Colleen E Pellegrini, BA||(215) firstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pennsylvania Health System||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Colleen E Pellegrini, BA 215-294-9611 email@example.com|
|Principal Investigator: David Steinberg, MD|
|Principal Investigator:||David Steinberg, MD||University of Pennsylvania|