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The purpose of this study is to determine the efficacy of intra-operative administration of IV tylenol and/or IV toradol in minimizing post-operative pain for carpal tunnel patients and distal radius fracture patients.
The study population will include patients presenting for surgery with carpal tunnel syndrome as well as surgical treatment of distal radius fracture. Patients will be treated intra-operatively with either IV tylenol, IV toradol, both, or neither. All patients will receive the standard post-operative prescriptions for pain management. Daily pain surveys scoring pain from 0-10 will be distributed to the subjects to be filled out over the course of 10 days prior to first post-operative visit, usually 10-14 days later. Number of pain pills used before the first post-operative visit will also be measured.
We hypothesize that the effects of intra-operative administration of IV tylenol and/or IV toradol will have a significant effect on decreasing post-operative pain in the first 10 days following distal radius fracture surgeries, with a significant difference in pain described as at least a 2 points on a 0-10 pain scale.
We also hypothesize that intra-operative administration of IV tylenol and/or IV toradol will not have such significant effect on decreasing post-operative pain for carpal tunnel release surgery.
A secondary aim is to evaluate the post-operative opioid consumption of patients within these treatment groups. We hypothesize that opioid consumption will be decreased in the groups receiving IV tylenol and/or toradol for distal radius fracture surgery compared to the placebo group. We do not expect such a difference for the carpal tunnel release surgery group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV tylenol | Experimental | One time intra-operative IV acetaminophen administration |
|
| IV toradol | Experimental | One time intra-operative IV ketorolac thromethamine administration |
|
| IV tylenol/toradol combination | Experimental | One time intra-operative IV combination of acetaminophen/ketorolac administration |
|
| saline | Placebo Comparator | One time intra-operative 50ml IV normal saline administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain (Pain Scores From 0-10 Scale) | This is an ordinal pain scale. The patient picks a number from 0-10 scale every 4 hours for 7 days post-operatively. 0 is no pain, 10 is the worst pain imaginable. Lower scores would be preferable to higher scores. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption (Number of Pills Taken) | Daily opioid consumption assessed as number of pills taken that day, each day for 7 days post-operatively Outcome measure reported below is mean number of opioid pills consumed per day. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaufmann Building | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12631041 | Background | Hahn TW, Mogensen T, Lund C, Jacobsen LS, Hjortsoe NC, Rasmussen SN, Rasmussen M. Analgesic effect of i.v. paracetamol: possible ceiling effect of paracetamol in postoperative pain. Acta Anaesthesiol Scand. 2003 Feb;47(2):138-45. doi: 10.1034/j.1399-6576.2003.00046.x. | |
| 24654353 | Background | Baley K, Michalov K, Kossick MA, McDowell M. Intravenous acetaminophen and intravenous ketorolac for management of pediatric surgical pain: a literature review. AANA J. 2014 Feb;82(1):53-64. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Tylenol | One time intra-operative IV acetaminophen administration Acetaminophen |
| FG001 | IV Toradol | One time intra-operative IV ketorolac thromethamine administration Ketorolac Tromethamine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2017 | Apr 2, 2018 |
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| Ketorolac Tromethamine |
| Drug |
|
|
| Saline | Drug |
|
| 21627768 | Background | Smith HS. Perioperative intravenous acetaminophen and NSAIDs. Pain Med. 2011 Jun;12(6):961-81. doi: 10.1111/j.1526-4637.2011.01141.x. Epub 2011 May 31. |
| 16613928 | Background | Alhashemi JA, Daghistani MF. Effects of intraoperative i.v. acetaminophen vs i.m. meperidine on post-tonsillectomy pain in children. Br J Anaesth. 2006 Jun;96(6):790-5. doi: 10.1093/bja/ael084. Epub 2006 Apr 13. |
| FG002 | IV Tylenol/Toradol Combination | One time intra-operative IV combination of acetaminophen/ketorolac administration Acetaminophen Ketorolac Tromethamine |
| FG003 | Saline | One time intra-operative 50ml IV normal saline administration Saline |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Tylenol | One time intra-operative IV acetaminophen administration Acetaminophen |
| BG001 | IV Toradol | One time intra-operative IV ketorolac thromethamine administration Ketorolac Tromethamine |
| BG002 | IV Tylenol/Toradol Combination | One time intra-operative IV combination of acetaminophen/ketorolac administration Acetaminophen Ketorolac Tromethamine |
| BG003 | Saline | One time intra-operative 50ml IV normal saline administration Saline |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Pain (Pain Scores From 0-10 Scale) | This is an ordinal pain scale. The patient picks a number from 0-10 scale every 4 hours for 7 days post-operatively. 0 is no pain, 10 is the worst pain imaginable. Lower scores would be preferable to higher scores. | Posted | Mean | 95% Confidence Interval | units on a scale | 7 days |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Opioid Consumption (Number of Pills Taken) | Daily opioid consumption assessed as number of pills taken that day, each day for 7 days post-operatively Outcome measure reported below is mean number of opioid pills consumed per day. | Posted | Mean | Full Range | pills consumed | 7 days |
|
Time frame is 90 days after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IV Tylenol | One time intra-operative IV acetaminophen administration Acetaminophen | 0 | 11 | 0 | 11 | 0 | 11 |
| EG001 | IV Toradol | One time intra-operative IV ketorolac thromethamine administration Ketorolac Tromethamine | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | IV Tylenol/Toradol Combination | One time intra-operative IV combination of acetaminophen/ketorolac administration Acetaminophen Ketorolac Tromethamine | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | Saline | One time intra-operative 50ml IV normal saline administration Saline | 0 | 11 | 0 | 11 | 0 | 11 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John R Fowler, MD | University of Pittsbur | 412-605-3245 | fowlerjr@upmc.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 25, 2017 | Apr 3, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000092503 | Wrist Fractures |
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D020911 | Ketorolac Tromethamine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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