Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries
NCT ID: NCT02313675
Last Updated: 2018-05-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
44 participants
INTERVENTIONAL
2015-05-31
2017-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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IV tylenol
One time intra-operative IV acetaminophen administration
Acetaminophen
IV toradol
One time intra-operative IV ketorolac thromethamine administration
Ketorolac Tromethamine
IV tylenol/toradol combination
One time intra-operative IV combination of acetaminophen/ketorolac administration
Acetaminophen
Ketorolac Tromethamine
saline
One time intra-operative 50ml IV normal saline administration
Saline
Interventions
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Acetaminophen
Ketorolac Tromethamine
Saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* distal radius fracture surgery candidates
Exclusion Criteria
* pregnant women,
* prisoners
18 Years
ALL
Yes
Sponsors
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John Fowler
OTHER
Responsible Party
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John Fowler
MD
Locations
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Kaufmann Building
Pittsburgh, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PRO14110464
Identifier Type: -
Identifier Source: org_study_id
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