Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries
Primary Purpose
Postoperative Pain, Carpal Tunnel Release, Distal Radius Fracture
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Ketorolac Tromethamine
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring carpal tunnel syndrome, opioid analgesics, postoperative pain, IV tylenol, IV toradol
Eligibility Criteria
Inclusion Criteria:
- carpal tunnel release surgery candidates,
- distal radius fracture surgery candidates
Exclusion Criteria:
- under 18 years of age,
- pregnant women,
- prisoners
Sites / Locations
- Kaufmann Building
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
IV tylenol
IV toradol
IV tylenol/toradol combination
saline
Arm Description
One time intra-operative IV acetaminophen administration
One time intra-operative IV ketorolac thromethamine administration
One time intra-operative IV combination of acetaminophen/ketorolac administration
One time intra-operative 50ml IV normal saline administration
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02313675
Brief Title
Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries
Official Title
Comparing Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol Administration for Carpal Tunnel Release and Distal Radius Fracture Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John Fowler
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Carpal Tunnel Release, Distal Radius Fracture
Keywords
carpal tunnel syndrome, opioid analgesics, postoperative pain, IV tylenol, IV toradol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV tylenol
Arm Type
Experimental
Arm Description
One time intra-operative IV acetaminophen administration
Arm Title
IV toradol
Arm Type
Experimental
Arm Description
One time intra-operative IV ketorolac thromethamine administration
Arm Title
IV tylenol/toradol combination
Arm Type
Experimental
Arm Description
One time intra-operative IV combination of acetaminophen/ketorolac administration
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
One time intra-operative 50ml IV normal saline administration
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
tylenol
Intervention Type
Drug
Intervention Name(s)
Ketorolac Tromethamine
Other Intervention Name(s)
toradol
Intervention Type
Drug
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Postoperative Pain (Pain Scores From 0-10 Scale)
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Opioid Consumption (Number of Pills Taken)
Description
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.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
carpal tunnel release surgery candidates,
distal radius fracture surgery candidates
Exclusion Criteria:
under 18 years of age,
pregnant women,
prisoners
Facility Information:
Facility Name
Kaufmann Building
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12631041
Citation
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.
Results Reference
background
PubMed Identifier
24654353
Citation
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.
Results Reference
background
PubMed Identifier
21627768
Citation
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.
Results Reference
background
PubMed Identifier
16613928
Citation
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.
Results Reference
background
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Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries
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